Sexual concerns are among the most common reasons women seek care in gynecology, menopause, functional and aesthetic medicine practices. In the National Health and Social Life Survey, Laumann, Paik and Rosen reported sexual dysfunction in 43 percent of women aged 18 to 59 in 1999, and the PRESIDE survey of 31,581 women by Shifren and colleagues in 2008 found that 43.1 percent reported a sexual problem and 12.0 percent a problem that caused them distress, a share that reached 14.8 percent between ages 45 and 64.
Regenerative biologics are studied in this area in three forms: platelet-rich plasma injected into the anterior vaginal wall, the clitoral region or the vulva; adipose-derived cells and fat grafting for vulvar disease; and umbilical cord mesenchymal stromal cells and their extracellular vesicles, studied mainly in menopause and ovarian models. This review sets out the physiology each targets, what the clinical trials report domain by domain, what the preclinical vesicle literature shows about blood flow and tissue, the registered trials, and the documentation a practice keeps. It is written for gynecology, urogynecology, menopause, aesthetic and regenerative practices and for investigators.
Regulatory position, stated once
PRP prepared at the point of care is a blood component, which 21 CFR 1271.3(d)(2) excludes from the definition of HCT/Ps, and PRP preparation systems reach the US market through 510(k) clearance under product code ORG, whose cleared indication is mixing with bone graft. The FDA states that there are no FDA-approved exosome products, and allogeneic umbilical cord or Wharton's jelly cell products used for treatment generally fall outside the four criteria of 21 CFR 1271.10(a) and follow the biologics pathway. Which material, for which patient and by which route are practitioner decisions this article does not make, and ExaVeyra Sciences supplies exosome material for topical aesthetic use by licensed practitioners and for IND-authorized research.
Desire, arousal and orgasm rely on blood flow, nerve supply and estrogen-responsive tissue
Genital arousal in women is a neurovascular event that parallels the male response. Nitric oxide and vasoactive intestinal polypeptide relax the smooth muscle of the clitoral corpora and the vaginal wall, inflow rises, the clitoris engorges and plasma transudate across the vaginal epithelium provides lubrication, a sequence that the clitoral anatomy work of O'Connell and colleagues placed in a larger erectile complex than older texts described.
Sensation travels mainly through the dorsal nerve of the clitoris, a branch of the pudendal nerve, while desire is governed centrally and is shaped by hormones, mood, relationship context and medications. The vulvovaginal tissue itself is estrogen-dependent, so the fall in estradiol at menopause thins the epithelium, reduces blood flow and lubrication and raises the vaginal pH, the cluster now named genitourinary syndrome of menopause. Regenerative research has concentrated on that tissue and vascular level, which is why most trials measure arousal, lubrication, pain and tissue quality more often than desire.
| Component | Role in sexual function | What disrupts it | Where regenerative research looks |
|---|---|---|---|
| Clitoral and vaginal vasculature | Engorgement, lubrication | Menopause, diabetes, vascular disease, smoking | Angiogenic signaling and blood flow in ovariectomized and diabetic rat models |
| Dorsal clitoral and pudendal nerves | Sensitivity, afferent input to orgasm | Pelvic surgery, childbirth injury, neuropathy | Neurotrophic signaling; sensitivity as a secondary trial endpoint |
| Vaginal epithelium and lamina propria | Barrier, elasticity, comfort during intercourse | Estradiol decline, lichen sclerosus, radiation | Collagen, elastin and epithelial thickness after PRP or MSC-derived material |
| Vulvar skin | Comfort, architecture of the clitoral hood and labia | Lichen sclerosus scarring | PRP, fat grafting and adipose-derived cells in clinical studies |
| Pelvic floor and urethral support | Continence and confidence during sex | Childbirth, age, estradiol decline | PRP and cell injections in stress urinary incontinence trials |
| Ovaries and central circuits | Hormonal milieu, desire | Menopause, premature ovarian insufficiency, depression, medications | Ovarian function research with umbilical cord MSCs; hormone optimization |
Because these components are separate, trial endpoints differ widely. The Female Sexual Function Index (FSFI) scores desire, arousal, lubrication, orgasm, satisfaction and pain separately, with a total up to 36 and a cutoff of 26.55 commonly used to identify dysfunction, so the trials below are described by the domains they actually reported.
PRP has moved from pilot series to randomized trials in four areas of women's sexual health
Sexual function: from an 11-patient pilot to a saline-controlled trial
The PRP literature in female sexual function began with an 11-woman pilot by Runels and colleagues in 2014, which reported a rise in total FSFI from 24.13 to 29.63 at 12 to 16 weeks after injection near the clitoris and the anterior vaginal wall, with gains in the arousal, lubrication and orgasm domains. Two participants reported transient heightened arousal that resolved within one to two weeks, and the first author originated the trademarked procedure the study describes.
Sukgen and colleagues reported a larger retrospective series in 2019, 52 women with sexual dysfunction or orgasmic disorder treated with four monthly PRP sessions to the lower anterior vaginal wall and peri-clitoral area. Total FSFI rose from 13.61 to 27.88 at six months, the orgasm domain from 2.11 to 4.48, every domain improved, half the women reached a total FSFI of 26 or above afterwards, and no adverse effects were reported.
The first saline-controlled randomized trial of vaginal PRP for sexual function in premenopausal women was published by Clarke, Dieter and colleagues at MedStar in 2026 (NCT05769283). It randomized 52 sexually active premenopausal women to one anterior vaginal wall injection of PRP or saline, and reported a median FSFI change of 2.2 with PRP against 0.3 with saline at six weeks (P = .05), with 69.2 percent of the PRP group reporting improvement on the Patient Global Impression of Improvement at six months against 34.6 percent with saline (P = .01). Subdomain differences did not reach significance after adjustment, injection was more painful with PRP, and there were no serious adverse events. Dankova and colleagues had earlier systematically reviewed 12 studies of 327 women in 2023 and reported improvement in most of the sexual dysfunction studies and in all seven incontinence studies, with minor adverse events in under 1 percent, while calling for high-quality randomized trials of the kind that has now begun to appear.
Genitourinary syndrome of menopause and vulvovaginal atrophy
In postmenopausal women with vulvovaginal atrophy, Abdel Hamid and colleagues at Ain Shams University randomized 60 women to vaginal mucosal PRP or saline (NCT03898401) and reported a total FSFI of 19.0 against 9.7 at four months (P < .001), with significant gains in lubrication, satisfaction and pain and no significant difference in desire, arousal or orgasm. The authors describe the study as a pilot.
Breast cancer survivors, for whom vaginal estradiol is often avoided or used only after oncology review, are a group of particular research interest. Hersant and colleagues treated 20 survivors with PRP combined with hyaluronic acid in a 2018 phase 2 pilot and reported a significant rise in the Vaginal Health Index and a 17 percent fall in sexual distress at six months, without adverse events. Chen, Trabuco and colleagues at Mayo Clinic gave 20 survivors a single diffuse vaginal PRP injection in a phase 1 study (NCT04535323), reported that every participant tolerated it, and found improvement in all secondary measures at weeks 4, 12 and 26 except the vaginal maturation index, with no difference between women taking aromatase inhibitors and those who were not. Waghe and colleagues reviewed the GSM literature in 2024 and found the strongest signals for PRP in combination protocols.
Vulvar lichen sclerosus
Lichen sclerosus scars the vulva, can bury the clitoris and narrow the introitus, and so bears directly on sexual function. Goldstein and colleagues reported reduced inflammation on biopsy in 7 of 12 women after intradermal PRP in 2017, and Tedesco and colleagues reported in 2022 that, among 51 women in a 94-patient cohort, pain fell from 33.3 to 7.8 percent, burning from 51.0 to 15.7 percent and itching from 80.4 to 21.6 percent, with no adverse outcomes. Medina Garrido and colleagues reported mid-term relief of itching, burning and soreness in 23 women in 2023.
The one double-blind randomized trial to date, by Goldstein and colleagues in 2019 (NCT03045172), compared PRP with saline in 29 women (19 PRP, 10 saline) and found no statistically significant difference between arms in histologic inflammation or in patient-reported symptom scores, which improved in both arms. Beutler and colleagues reviewed 13 regenerative studies of 360 women in 2025 and concluded that PRP, adipose-derived cells and mesotherapy may help, and a 68-patient double-blind trial in Adelaide whose protocol was published in 2025 closed enrollment early at 34 participants because of slow recruitment, with results expected.
Stress urinary incontinence and sexual confidence
Incontinence during intercourse is a frequent and under-reported concern, and PRP to the anterior vaginal wall near the mid-urethra is now in randomized trials. Athanasiou and colleagues randomized 50 women to PRP or sham in 2024 and reported subjective cure in 32 percent with PRP against 4 percent with sham (P < .001), with greater pad-test improvement at six months. Saraluck and colleagues added PRP to pelvic floor muscle training in 60 women and reported about 8 g more reduction in pad weight at five months, Ashton and colleagues found no significant difference between a single PRP injection and saline in 50 women, and Long and colleagues reported 60 percent success at six months in a 20-woman series, in which FSFI rose from 17.9 to 20.3 without reaching significance.
| Study | Design | n | Population | Main sexual-health endpoint reported | Follow-up |
|---|---|---|---|---|---|
| Clarke 2026 | Single-blind RCT, PRP vs saline | 52 | Premenopausal, sexually active | FSFI change 2.2 vs 0.3 (P = .05); PGI-I 69.2 vs 34.6% at 6 months | 6 months |
| Abdel Hamid 2025 | RCT, PRP vs saline | 60 | Postmenopausal, vulvovaginal atrophy | FSFI 19.0 vs 9.7 (P < .001) | 4 months |
| Chen 2025 | Phase 1, single arm | 20 | Breast cancer survivors with GSM | Feasibility; secondary measures improved | 26 weeks |
| Hersant 2018 | Phase 2 pilot, PRP plus hyaluronic acid | 20 | Breast cancer survivors with atrophy | Vaginal Health Index; distress down 17% | 6 months |
| Sukgen 2019 | Retrospective series | 52 | Sexual dysfunction or orgasmic disorder | FSFI 13.61 to 27.88 | 6 months |
| Runels 2014 | Uncontrolled pilot | 11 | Sexual dysfunction | FSFI 24.13 to 29.63 | 12 to 16 weeks |
| Goldstein 2019 | Double-blind RCT, PRP vs saline | 29 | Vulvar lichen sclerosus | Histology and symptom score; no significant difference between arms | After 2 sessions |
| Tedesco 2022 | Cohort | 94 (51 women) | Genital lichen sclerosus | Pain, burning, itching prevalence | Per protocol |
| Athanasiou 2024 | RCT, PRP vs sham | 50 | Stress urinary incontinence | Reported subjective cure 32 vs 4% | 6 months |
| Saraluck 2024 | RCT, PRP plus pelvic floor training | 60 | Stress urinary incontinence | Pad weight | 5 months |
| Dankova 2023 | Systematic review | 12 studies, 327 women | Sexual dysfunction and SUI | Improvement in most FSD studies and all SUI studies | Varied |
Cell-based studies span vulvar tissue, continence and ovarian function, and umbilical cord cells lead the ovarian work
Fat grafting and adipose-derived cells in vulvar lichen sclerosus
Adipose tissue carries stromal vascular fraction cells and adipose-derived stromal cells, and it is the most clinically studied cell source in vulvar disease. Boero and colleagues treated 36 women with autologous fat grafting between 2011 and 2014 and reported improved vulvar trophism in 94 percent, better introital caliber and elasticity in 75 percent, reduced clitoral burying in half, and significant gains in quality of life and FSFI, with most patients able to stop routine topical steroids.
Monreal reported 39 women treated with stromal vascular fraction enriched fat grafting in 2020, with improvement in 94.9 percent and a fall in the global symptom score from 93.56 to 43.59 at 24 months, alongside a fall in the sexual functioning subscore from 15.64 to 8.44, where lower scores indicate fewer symptoms. Almadori and colleagues reported improved sexual function, pain, itching and tissue architecture in a 33-woman prospective cohort treated with autologous fat grafting in 2020.
Autologous muscle-derived cells in stress urinary incontinence
The largest cell trial in female pelvic health is the phase 3 iltamiocel study reported by Kaufman and colleagues in 2024 (NCT01893138), which randomized 297 women 2:1 to 150 million autologous muscle-derived cells or placebo. The primary endpoint was similar between arms, 52 against 53.6 percent achieving at least a 50 percent reduction in stress episodes, and in the prespecified subgroup with prior incontinence surgery 40 percent of the cell group reached a 75 percent reduction against 16 percent with placebo (P = .037).
Umbilical cord MSCs and ovarian function
Umbilical cord mesenchymal stromal cells, most often isolated from Wharton's jelly, are the cell population studied most in ovarian research, which bears on sexual health through the hormonal environment that supports desire and vulvovaginal tissue. Yan and colleagues treated 61 women aged 35 or younger with premature ovarian insufficiency using ultrasound-guided intraovarian umbilical cord MSC injection in 2020 (NCT03033277), and reported mature follicles in 31.1 percent after the first injection, any follicular development in 67.2 percent, better response with shorter amenorrhea, and four deliveries, with five mild and transient adverse events.
The Wharton's jelly source guide on this blog explains why the perivascular cord tissue yields a young-donor, HLA-DR negative cell population with a characteristic secretome, and why the tissue origin of a cell or vesicle product should be stated on its documentation. Published human gynecologic studies have described their cells as umbilical cord MSCs without always naming the cord compartment, and a registered phase 1 study of autologous stromal vascular fraction and PRP for ovarian rejuvenation, NCT04444245, lists 100 planned participants.
Vesicle research reports thicker vaginal epithelium, new microvessels and restored ovarian markers in animal models
Extracellular vesicles carry the proteins, microRNAs and lipids of the cells that secrete them, and the women's health literature has studied umbilical cord MSC vesicles in particular. Zhang and colleagues delivered umbilical cord MSC exosomes in a hydrogel to ovariectomized rats in 2023 and reported a thicker vaginal epithelium than in untreated ovariectomized animals, more proliferating cells by Ki67 and more microvessels by CD31, without a uterotrophic effect; estradiol restored epithelial thickness closer to that of intact animals, which gives the exosome result a useful reference point.
The vascular side of arousal now has a dedicated model. Li and colleagues established a rat model of female genital sexual arousal disorder in 2022 by combining vaginal dilatation with ovariectomy, and reported the largest fall in nerve-stimulated vaginal blood flow in that group, with lower smooth muscle actin, vessel density and VEGF and disrupted collagen and elastic fibers, endpoints that make blood flow measurable when biologics are tested. Ben Menachem-Zidon and colleagues reported in 2019 that bone marrow MSCs homed to a vaginal wound in rats and nearly doubled vessel counts, from 4.2 to about 8 per field, with donor-derived cells forming close to a quarter of the vessels.
In ovarian models the vesicle work is more mechanistic. Li and colleagues reported in 2021 that umbilical cord MSC exosomes moved AMH, estradiol and FSH toward normal and improved follicle counts and fertility in mice with chemotherapy-induced ovarian insufficiency through the Hippo pathway, with the effect abolished when YAP signaling was blocked, and Zhou and colleagues reported in 2024 that umbilical cord MSC exosomes reduced ferroptosis through the Nrf2 and GPX4 pathway in the same model.
| Study | Model | Material | Reported result |
|---|---|---|---|
| Zhang 2023 | Ovariectomized rat | Umbilical cord MSC exosomes in hydrogel | Thicker epithelium, more Ki67 and CD31 staining, no uterine stimulation |
| Li 2022 | Rat arousal disorder model | Model development | Vaginal blood flow, smooth muscle, VEGF and collagen as measurable endpoints |
| Ben Menachem-Zidon 2019 | Rat vaginal injury | Bone marrow MSCs | Vessels per field 4.2 to about 8 |
| Li 2021 | Mouse ovarian insufficiency | Umbilical cord MSC exosomes | AMH, estradiol, FSH and follicle counts improved via Hippo signaling |
| Zhou 2024 | Mouse ovarian insufficiency | Umbilical cord MSC exosomes | Ovarian markers improved; ferroptosis reduced via Nrf2 and GPX4 |
The human vesicle literature in women's sexual health has yet to report a controlled trial, so these animal results describe mechanisms under investigation, and a vesicle product's source cell, isolation method and characterization by lot determine which of these studies it can be compared with.
Six registered trials frame the next round of results
| Registry ID | Title (short) | Sponsor | Design | Enrollment | Status, verified October 2026 |
|---|---|---|---|---|---|
| NCT05769283 | Vaginal PRP for sexual function | MedStar Health Research Institute | Randomized, single-blind, PRP vs saline | 52 | Completed; published 2026 |
| NCT04535323 | PRP for GSM in stage 0 to III breast cancer | Mayo Clinic | Phase 1, single arm | 20 | Completed January 2024; published 2025 |
| NCT03045172 | PRP for vulvar lichen sclerosus | Center for Vulvovaginal Disorders | Randomized, PRP vs saline | 29 | Completed October 2018; published 2019 |
| NCT03189238 | PRP peri-urethral and clitoral injection for female orgasmic disorder | Center for Vulvovaginal Disorders | Phase 2, randomized, double-masked | 40 planned | Status unknown, last verified 2017 |
| NCT01893138 | Autologous muscle-derived cells for urinary sphincter repair | Cook MyoSite | Phase 3, randomized, placebo-controlled | 311 | Completed November 2020; results posted |
| NCT04444245 | Ovarian rejuvenation with PRP and stromal vascular fraction | Black Tie Medical | Phase 1, open label, 4 arms | 100 planned | Status unknown, last verified 2022 |
The orgasmic disorder trial is the only study in this table to name orgasm as its primary target. Its double-masked design compares peri-urethral and clitoral PRP with placebo, and its results would address the domain studied least so far.
The evidence base is early and expanding quickly
- Randomized trials have arrived in the last three years. Clarke 2026, Abdel Hamid 2025, Athanasiou 2024, Saraluck 2024 and Ashton 2024 join the 2019 lichen sclerosus trial, and most enrolled 29 to 60 women.
- Endpoints differ by domain, and lubrication, pain and tissue quality respond most often in the published studies, while desire is measured less often and orgasm has one dedicated registered trial.
- Preparations vary, since studies used different kits, spin protocols, volumes, injection sites and session counts, so each result belongs to the preparation that produced it, as the 2025 scoping review by Willison and colleagues noted.
- Follow-up is typically four to six months, with Monreal's 24-month fat grafting series and the 24-month iltamiocel durability data the longest.
- Several early studies were authored by originators of the procedures they describe, which the annotated references record, and the newer saline-controlled trials come from academic centers.
- Umbilical cord MSC and vesicle data in genital tissue are preclinical, and the human umbilical cord data come from ovarian studies.
No PRP system, cell product or exosome product is FDA-approved for a sexual-health indication
PRP prepared at the point of care is a blood component, excluded from the definition of HCT/Ps by 21 CFR 1271.3(d)(2), and its preparation systems are cleared through 510(k) under product code ORG for mixing with bone graft, so a gynecologic use is a practitioner's off-label decision. Allogeneic cell products, including umbilical cord and Wharton's jelly cells, are regulated solely under section 361 only when they meet all four criteria of 21 CFR 1271.10(a), and, per the FDA, products used for treatment generally follow the biologics pathway.
The FDA consumer alert on regenerative medicine products, current as of April 2024, states that there are no FDA-approved exosome products, and the agency's December 2019 public safety notification states that exosomes used to treat diseases and conditions are regulated as drugs and biological products. The agency's July 2018 communication on energy-based vaginal rejuvenation devices is relevant context for any practice that combines biologics with lasers or radiofrequency, because it stated that the safety and effectiveness of those devices for such procedures had not been established.
| Item | US status | Source |
|---|---|---|
| PRP prepared at the point of care | Blood component outside the HCT/P definition | 21 CFR 1271.3(d)(2) |
| PRP preparation systems | 510(k) cleared, Class II; indication is mixing with bone graft | FDA product code ORG |
| Allogeneic umbilical cord or Wharton's jelly cells | Section 361 only if all four 1271.10(a) criteria are met | 21 CFR 1271.10(a) |
| Exosome material | No FDA-approved product for any use | FDA consumer alert, 2024; FDA notification, 2019 |
| Energy-based vaginal devices | No cleared indication for rejuvenation procedures | FDA communication, 2018 |
Documentation each practice records
- The FSFI, FSDS-R or condition-specific instrument used, with baseline and follow-up dates, so that results can be read domain by domain
- For PRP: kit name, 510(k) number, lot, anticoagulant, centrifuge model, relative centrifugal force and time, volume and injection sites
- For fat grafting or stromal vascular fraction: harvest site, processing device and volume placed
- For exosome material: product name, source cell and tissue, lot number, certificate of analysis on file, storage temperature log and time from thaw to application
- Menopausal status, hormone use and, for survivors of breast cancer, endocrine therapy, since both shape vulvovaginal tissue
ExaVeyra Sciences supplies exosome material with the lot number and storage requirements on every order and the certificate of analysis for each lot available on request, so that a practice can file them against the record above. Randomized trials, standardized instruments and registered protocols are now arriving together in women's sexual health, and the practices that document their preparations carefully will be best placed to read each new result against their own work.
Aviso Educativo: This article is for educational purposes only and does not constitute medical or legal advice. It reviews published research and registered trials; it does not identify any material, compound, device setting or protocol as safe, effective or appropriate for any patient, and it is not intended to diagnose, treat, cure, or prevent any disease. Conditions named in this article are named as the subjects of the studies cited. Naming a condition studied in a model or a trial does not establish an indication for any product. Exosome material is supplied for topical aesthetic use by licensed practitioners and for laboratory and IND-authorized clinical research. No exosome product is FDA-approved for any use, and ExaVeyra Sciences makes no statement about administration, route, or outcome. Any use of research-grade material in human subjects requires the applicable FDA pathway, such as an investigational new drug application, and institutional review board oversight. Compounded medications are not FDA-approved. They are prepared by a 503A compounding pharmacy licensed by the Texas State Board of Pharmacy for an individual patient against that patient’s prescription, and are available to NPI-verified licensed practitioners only. Discussion of a compound’s literature, including compounds the FDA placed in category 2 of its 503A bulk drug substances policy, is not an offer to supply it. ExaVeyra Sciences is a supplier and takes no part in any diagnosis, treatment decision, study design decision, or plan of care. Findings described are attributed to the peer-reviewed literature, trial registries and agencies cited, and a citation establishes that a question was studied, leaving the suitability of any product for a given patient or protocol to the practitioner’s judgment. The content of these guides is provided for general informational purposes only. It does not constitute legal, medical, or regulatory advice, and does not establish that any particular product or practice is compliant. Regulatory requirements vary by state and depend on the circumstances of each practice. Each practitioner should consult their own legal counsel and the applicable state licensing boards before acting on anything stated here.
Referencias
- 1.Laumann EO, Paik A, Rosen RC. Sexual dysfunction in the United States: prevalence and predictors. JAMA. 1999;281(6):537-544. PMID 10022110. doi:10.1001/jama.281.6.537.National Health and Social Life Survey; 1,749 women and 1,410 men aged 18 to 59. Carries in this article: sexual dysfunction in 43 percent of women; low desire 22, arousal problems 14 and sexual pain 7 percent (pre-2011 landmark).
- 2.Shifren JL, Monz BU, Russo PA, Segreti A, Johannes CB. Sexual problems and distress in United States women: prevalence and correlates. Obstet Gynecol. 2008;112(5):970-978. PMID 18978095.PRESIDE national survey; 31,581 women aged 18 and over. Carries in this article: any sexual problem 43.1 percent, distressing problem 12.0 percent overall and 14.8 percent at ages 45 to 64 (pre-2011 landmark). Disclosure: industry-supported survey; a press release was issued by Boehringer Ingelheim.
- 3.O'Connell HE, Sanjeevan KV, Hutson JM. Anatomy of the clitoris. J Urol. 2005;174(4 Pt 1):1189-1195. PMID 16145367. doi:10.1097/01.ju.0000173639.38898.cd.Anatomical review with dissection and imaging. Carries in this article: the clitoris as a larger erectile complex than older texts described (pre-2011 landmark).
- 4.Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000;26(2):191-208. PMID 10782451. doi:10.1080/009262300278597.Validation study of the 19-item instrument. Carries in this article: the FSFI domain structure used by most trials below (pre-2011 landmark).
- 5.Wiegel M, Meston C, Rosen R. The Female Sexual Function Index (FSFI): cross-validation and development of clinical cutoff scores. J Sex Marital Ther. 2005;31(1):1-20. PMID 15841702. doi:10.1080/00926230590475206.Cross-validation study. Carries in this article: the total-score cutoff of 26.55 commonly used to identify dysfunction, on a total range of 2.0 to 36.0 (pre-2011 landmark).
- 6.Parish SJ, Goldstein AT, Goldstein SW, Goldstein I, Pfaus J, Clayton AH, et al. Toward a more evidence-based nosology and nomenclature for female sexual dysfunctions, Part II. J Sex Med. 2016;13(12):1888-1906. PMID 27843072. doi:10.1016/j.jsxm.2016.09.020.ISSWSH consensus nomenclature. Carries in this article: the desire, arousal, orgasm and pain categories used to read trial domains.
- 7.Clayton AH, Goldstein I, Kim NN, Althof SE, Faubion SS, Faught BM, et al. The International Society for the Study of Women's Sexual Health process of care for management of hypoactive sexual desire disorder in women. Mayo Clin Proc. 2018;93(4):467-487. PMID 29545008. doi:10.1016/j.mayocp.2017.11.002.ISSWSH process of care. Carries in this article: desire as a centrally governed, multifactorial domain managed through a structured care pathway.
- 8.American College of Obstetricians and Gynecologists. Female sexual dysfunction: ACOG Practice Bulletin No. 213. Obstet Gynecol. 2019;134(1):e1-e18. PMID 31241598.Clinical practice guidance. Carries in this article: the specialty society framework for evaluating female sexual dysfunction.
- 9.The NAMS 2020 GSM Position Statement Editorial Panel. The 2020 genitourinary syndrome of menopause position statement of The North American Menopause Society. Menopause. 2020;27(9):976-992. PMID 32852449. doi:10.1097/GME.0000000000001609.Position statement. Carries in this article: GSM in an estimated 27 to 84 percent of postmenopausal women; lubricants and moisturizers first-line; low-dose vaginal hormone therapy for moderate to severe GSM or when nonhormone options are not enough. Disclosure: no commercial support; several panelists report industry relationships.
- 10.Runels C, Melnick H, Debourbon E, Roy L. A pilot study of the effect of localized injections of autologous platelet rich plasma (PRP) for the treatment of female sexual dysfunction. J Women's Health Care. 2014;3(4):169. doi:10.4172/2167-0420.1000169.Uncontrolled pilot; n = 11, ages 24 to 64; 12 to 16 weeks. Carries in this article: FSFI 24.13 to 29.63 (P = .01); arousal, lubrication and orgasm gains; two transient episodes of heightened arousal. Disclosure: not indexed in PubMed; the first author originated the trademarked procedure.
- 11.Sukgen G, Ellibeş Kaya A, Karagün E, Çalışkan E. Platelet-rich plasma administration to the lower anterior vaginal wall to improve female sexuality satisfaction. Turk J Obstet Gynecol. 2019;16(4):228-234. PMID 32231853. PMC7090261. doi:10.4274/tjod.galenos.2019.23356.Retrospective series; n = 52; four monthly sessions; 6 months. Carries in this article: FSFI 13.61 to 27.88 and orgasm 2.11 to 4.48 (P < .001); no adverse effects. Disclosure: declared: none.
- 12.Clarke B, Gaddam N, Garcia B, Iglesia CB, Podolsky R, Dieter AA. Vaginal injection of platelet-rich plasma for sexual function: a randomized controlled trial. Obstet Gynecol. 2026;147(5):627-635. PMID 41855531. doi:10.1097/AOG.0000000000006256.Single-blind RCT, PRP vs saline; n = 52 premenopausal women; NCT05769283; 6 months. Carries in this article: FSFI change 2.2 vs 0.3 at 6 weeks (P = .05); PGI-I improvement 69.2 vs 34.6 percent at 6 months (P = .01); no serious adverse events. Disclosure: funded by the SHE+ Foundation; authors reported no conflicts.
- 13.Dankova I, Pyrgidis N, Tishukov M, Georgiadou E, Nigdelis MP, Solomayer EF, et al. Efficacy and safety of platelet-rich plasma injections for the treatment of female sexual dysfunction and stress urinary incontinence: a systematic review. Biomedicines. 2023;11(11):2919. PMID 38001920. PMC10669888. doi:10.3390/biomedicines11112919.PRISMA systematic review; 12 studies, 327 women. Carries in this article: improvement in most FSD studies and all seven SUI studies; minor adverse events under 1 percent (3 of 317). Disclosure: declared: none.
- 14.Abdel Hamid AS, AbdAllah AM, Fathi HM, Bahaa Eldin AM, Abd el Hadi RMM. Value of injection of plasma-rich platelets in the vaginal mucosa in cases with vulvovaginal atrophy: a prospective double-blinded randomized controlled study. BMC Womens Health. 2025;25:576. PMID 41291715. PMC12648869. doi:10.1186/s12905-025-04076-5.RCT, PRP vs saline; n = 60 postmenopausal women; NCT03898401; 4 months. Carries in this article: FSFI 19.0 vs 9.7 (P < .001), with lubrication, satisfaction and pain domains improved. Disclosure: declared: none.
- 15.Hersant B, SidAhmed-Mezi M, Belkacemi Y, Darmon F, Bastuji-Garin S, Werkoff G, et al. Efficacy of injecting platelet concentrate combined with hyaluronic acid for the treatment of vulvovaginal atrophy in postmenopausal women with history of breast cancer: a phase 2 pilot study. Menopause. 2018;25(10):1124-1130. PMID 29738415. doi:10.1097/GME.0000000000001122.Single-arm phase 2 pilot; n = 20 survivors; 6 months. Carries in this article: Vaginal Health Index rose (P < .0001); sexual distress down 17 percent; no adverse events.
- 16.Chen AH, Trabuco EC, Chumsri S, Thielen JM, Cornella JL, Shapiro SA, et al. Platelet-rich plasma for genitourinary syndrome of menopause in breast cancer survivors. Obstet Gynecol. 2025;146(5):728-736. PMID 40966714. doi:10.1097/AOG.0000000000006081.Phase 1 single-arm study; n = 20; NCT04535323; 26 weeks. Carries in this article: tolerated by all participants; secondary measures improved at weeks 4, 12 and 26 except the vaginal maturation index; no serious adverse events.
- 17.Waghe T, Acharya N, Karnik M, Mohammad S, Patel NA, Gemnani R. Role of platelet-rich plasma in genitourinary syndrome of menopause. Cureus. 2024;16(1):e53316. PMID 38435897. PMC10906939. doi:10.7759/cureus.53316.Review of 7 sources. Carries in this article: the strongest GSM signals came from PRP in combination protocols. Disclosure: declared: none.
- 18.Willison N, Behnia-Willison F, Aryan P, Padhani ZA, Mirzaei Damabi N, Nguyen T, et al. Application of platelet-rich plasma in gynaecologic disorders: a scoping review. J Clin Med. 2025;14(16):5832. PMID 40869658. doi:10.3390/jcm14165832.PRISMA-ScR scoping review. Carries in this article: PRP shows promise across gynecology, with preparation and protocols needing standardization. Disclosure: declared: none; the author group overlaps with the investigators of the trial at entry 24.
- 19.Goldstein AT, King M, Runels C, Gloth M, Pfau R. Intradermal injection of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus. J Am Acad Dermatol. 2017;76(1):158-160. PMID 27986140. doi:10.1016/j.jaad.2016.07.037.Uncontrolled cohort; n = 12. Carries in this article: reduced inflammation on biopsy in 7 of 12; investigator global score 2.67 to 1.83 (P = .0054).
- 20.Goldstein AT, Mitchell L, Govind V, Heller D. A randomized double-blind placebo-controlled trial of autologous platelet-rich plasma intradermal injections for the treatment of vulvar lichen sclerosus. J Am Acad Dermatol. 2019;80(6):1788-1789. PMID 30639885. doi:10.1016/j.jaad.2018.12.060.Double-blind RCT, PRP vs saline; n = 29; NCT03045172. Carries in this article: both arms improved on histology and symptom scores, with no significant difference between them (P = .542 and .654).
- 21.Tedesco M, Garelli V, Bellei B, Sperduti I, Chichierchia G, Latini A, et al. Platelet-rich plasma for genital lichen sclerosus: analysis and results of 94 patients. J Dermatolog Treat. 2022;33(3):1558-1562. PMID 33226278. doi:10.1080/09546634.2020.1854650.Cohort; 94 patients, 51 women. Carries in this article: in women, pain 33.3 to 7.8 percent, burning 51.0 to 15.7 percent, itching 80.4 to 21.6 percent; no adverse outcomes.
- 22.Medina Garrido C, Cano García A, de la Cruz Cea L, Oreja Cuesta AB. Mid-term symptomatic relief after platelet-rich plasma infiltration in vulvar lichen sclerosus. Arch Dermatol Res. 2023;315(6):1527-1532. PMID 36656384. PMC10338614. doi:10.1007/s00403-023-02529-1.Cohort; 28 enrolled, 23 completed. Carries in this article: itching 6.8 to 3.9, burning 5.8 to 3.9 and soreness 4.1 to 2.5 after the third infiltration.
- 23.Beutler K, Jankowska-Konsur A, Nowicka D. Regenerative approaches in vulvar lichen sclerosus: a systematic review. Int J Mol Sci. 2025;26(18):8808. PMID 41009377. PMC12469362. doi:10.3390/ijms26188808.PRISMA systematic review; 13 studies, 360 women. Carries in this article: PRP, adipose-derived cells and mesotherapy may help; samples small and follow-up short. Disclosure: declared: none.
- 24.Nguyen T, Beljic M, Willison N, Taheri M, Aryan P, Abbott D, et al. Platelet-rich plasma versus saline for the treatment of vulvar lichen sclerosus: protocol for a randomized controlled trial. JMIR Res Protoc. 2025;14:e68871. PMID 40902148. PMC12444214. doi:10.2196/68871.ACTRN12618001321235p. Double-blind RCT protocol; planned n = 68. Carries in this article: enrollment closed in September 2024 at 34 participants, results expected. Disclosure: declared: none.
- 25.Boero V, Brambilla M, Sipio E, Liverani CA, Di Martino M, Agnoli B, et al. Vulvar lichen sclerosus: a new regenerative approach through fat grafting. Gynecol Oncol. 2015;139(3):471-475. PMID 26499935. doi:10.1016/j.ygyno.2015.10.014.Uncontrolled cohort; n = 36. Carries in this article: improved trophism in 94 percent, introital caliber and elasticity in 75 percent, reduced clitoral burying in half; FSFI improved.
- 26.Monreal J. Safety and efficacy of stromal vascular fraction enriched fat grafting therapy for vulvar lichen sclerosus. Cureus. 2020;12(2):e7096. PMID 32231892. PMC7098413. doi:10.7759/cureus.7096.Retrospective series; n = 39; 24 months. Carries in this article: improvement in 94.9 percent; symptom score 93.56 to 43.59; sexual functioning subscore 15.64 to 8.44. Disclosure: declared: none.
- 27.Almadori A, Hansen E, Boyle D, Zenner N, Swale V, Reid W, et al. Fat grafting improves fibrosis and scarring in vulvar lichen sclerosus: results from a prospective cohort study. J Low Genit Tract Dis. 2020;24(3):305-310. PMID 32205767. doi:10.1097/LGT.0000000000000520.Prospective cohort; n = 33; single autologous fat graft; mean 12.9 months. Carries in this article: improved sexual function, pain, itching and tissue architecture.
- 28.Athanasiou S, Grigoriadis T, Kalantzis C, Zacharakis D, Kathopoulis N, Prodromidou A, et al. Platelet-rich plasma for the treatment of stress urinary incontinence: a randomized trial. Urogynecology (Phila). 2024;30(1):42-49. PMID 37493287. doi:10.1097/SPV.0000000000001378.RCT, PRP vs sham; n = 50; 6 months. Carries in this article: the trial reported subjective cure 32 vs 4 percent (P < .001); greater pad-test improvement.
- 29.Saraluck A, Chinthakanan O, Kijmanawat A, Aimjirakul K, Wattanayingcharoenchai R, Manonai J. Autologous platelet rich plasma combined with pelvic floor muscle training for the treatment of female stress urinary incontinence: a randomized control clinical trial. Neurourol Urodyn. 2024;43(2):342-353. doi:10.1002/nau.25365.Single-blind RCT; n = 60; 5 months. Carries in this article: about 8 g greater pad-weight reduction with PRP added.
- 30.Ashton L, Nataksuka H, Johnson CM, Kenne K, Kreder KJ, Kruse R, et al. A single injection of platelet-rich plasma injection for the treatment of stress urinary incontinence in females: a randomized placebo-controlled trial. Urology. 2024;193:63-68. PMID 38942391. PMC12826440. doi:10.1016/j.urology.2024.06.047.RCT, PRP vs saline; n = 50; 6 months. Carries in this article: no significant difference after a single injection; minor adverse events similar between arms.
- 31.Long CY, Lin KL, Shen CR, Ker CR, Liu YY, Loo ZX, et al. A pilot study: effectiveness of local injection of autologous platelet-rich plasma in treating women with stress urinary incontinence. Sci Rep. 2021;11:1584. PMID 33452330. PMC7810841. doi:10.1038/s41598-020-80598-2.Single-arm study; n = 20; NCT04279210; 6 months. Carries in this article: success in 60 percent; FSFI 17.9 to 20.3 (P = .25). Disclosure: declared: none.
- 32.Kaufman MR, Goldman HB, Chermansky CJ, Dmochowski R, Kennelly MJ, Peters KM, et al. Iltamiocel autologous cell therapy for the treatment of female stress urinary incontinence: a double-blind, randomized, stratified, placebo-controlled trial. Neurourol Urodyn. 2024;43(8):2290-2299. PMID 39282854. doi:10.1002/nau.25588.Phase 3 RCT, 2:1; the trial treated 297; NCT01893138; 12 months. Carries in this article: primary endpoint 52 vs 53.6 percent; prior-surgery subgroup 40 vs 16 percent (P = .037). Disclosure: industry sponsor Cook MyoSite.
- 33.Yan L, Wu Y, Li L, Wu J, Zhao F, Gao Z, et al. Clinical analysis of human umbilical cord mesenchymal stem cell allotransplantation in patients with premature ovarian insufficiency. Cell Prolif. 2020;53(12):e12938. PMID 33124125. PMC7705906. doi:10.1111/cpr.12938.Non-randomized study; n = 61; NCT03033277; 6 months. Carries in this article: mature follicles in 31.1 percent, any follicle in 67.2 percent, four deliveries, five mild transient adverse events. Disclosure: national grants; declared: none.
- 34.Zhang T, Li D, Wang Y, Zhang C, Yang W, Gao G. Delivering umbilical cord mesenchymal stem cell exosomes through hydrogel ameliorates vaginal atrophy in ovariectomized rats. Aging (Albany NY). 2023;15(23):14292-14305. PMID 38059876. PMC10756086. doi:10.18632/aging.205302.Animal study, ovariectomized rats, plus VK2 cells. Carries in this article: thicker epithelium, more Ki67 and CD31 staining, no uterotrophic effect. Disclosure: declared: none.
- 35.Li G, Yu P, Hu Y, et al. Establishment of rat model of female genital sexual arousal disorder. Sex Med. 2022;10(4):100530. PMID 35659678. PMC9386627. doi:10.1016/j.esxm.2022.100530.Animal model study; n = 10 per group. Carries in this article: vaginal blood flow, smooth muscle, VEGF and collagen as measurable arousal endpoints. Disclosure: declared: none.
- 36.Ben Menachem-Zidon O, Gropp M, Ben Shushan E, Reubinoff B, Shveiky D. Systemically transplanted mesenchymal stem cells induce vascular-like structure formation in a rat model of vaginal injury. PLoS One. 2019;14(6):e0218081. PMC6563972. doi:10.1371/journal.pone.0218081.Animal study, bone marrow MSCs; n = 5 per group per time point. Carries in this article: vessels per field 4.2 to about 8; donor-derived vessels near a quarter of the total.
- 37.Li Z, Zhang M, Zheng J, Tian Y, Zhang H, Tan Y, et al. Human umbilical cord mesenchymal stem cell-derived exosomes improve ovarian function and proliferation of premature ovarian insufficiency by regulating the Hippo signaling pathway. Front Endocrinol (Lausanne). 2021;12:711902. PMID 34456868. PMC8397419. doi:10.3389/fendo.2021.711902.Mouse model plus granulosa cells. Carries in this article: AMH, estradiol, FSH and follicle counts improved via YAP and TAZ. Disclosure: two authors employed by a cell therapy company.
- 38.Zhou Y, Huang J, Zeng L, Yang Q, Bai F, Mai Q, et al. Human mesenchymal stem cells derived exosomes improve ovarian function in chemotherapy-induced premature ovarian insufficiency mice by inhibiting ferroptosis through Nrf2/GPX4 pathway. J Ovarian Res. 2024;17:80. PMID 38622725. PMC11017636. doi:10.1186/s13048-024-01403-6.Mouse model plus KGN cells. Carries in this article: ovarian markers improved and ferroptosis reduced via Nrf2 and GPX4.
- 39.MedStar Health Research Institute. Vaginal injection of platelet rich plasma for sexual function. ClinicalTrials.gov NCT05769283. clinicaltrials.gov/study/NCT05769283.Randomized single-blind trial; 52 enrolled. Status verified October 2026: completed; published as entry 12.
- 40.Center for Vulvovaginal Disorders. A double blind placebo controlled trial of autologous PRP peri-urethral and clitoral injections for the treatment of female orgasmic disorder. ClinicalTrials.gov NCT03189238. clinicaltrials.gov/study/NCT03189238.Phase 2 randomized, double-masked; 40 planned. Status: unknown, last verified 2017; no results posted.
- 41.Center for Vulvovaginal Disorders. Platelet rich plasma (PRP) for vulvar lichen sclerosus. ClinicalTrials.gov NCT03045172. clinicaltrials.gov/study/NCT03045172.Randomized; 29 enrolled. Status: completed October 2018; published as entry 20.
- 42.Mayo Clinic. Platelet rich plasma for the treatment of genitourinary syndrome of menopause in patients with stage 0-III breast cancer. ClinicalTrials.gov NCT04535323. clinicaltrials.gov/study/NCT04535323.Phase 1 single arm; 20 enrolled. Status: completed January 2024; published as entry 16.
- 43.Cook MyoSite. Autologous muscle derived cells for female urinary sphincter repair. ClinicalTrials.gov NCT01893138. clinicaltrials.gov/study/NCT01893138.Phase 3 randomized, placebo-controlled; 311 enrolled. Status: completed November 2020; results posted.
- 44.Black Tie Medical, Inc. Ovarian rejuvenation using PRP and autologous tissue stromal vascular fraction (OVAR-REJUV). ClinicalTrials.gov NCT04444245. clinicaltrials.gov/study/NCT04444245.Phase 1 open label, 4 arms; 100 planned. Status: unknown, last verified 2022.
- 45.U.S. Food and Drug Administration. 21 CFR 1271.3(d), definition of HCT/Ps, including paragraph (d)(2), which excludes whole blood, blood components and blood derivative products. ecfr.gov/current/title-21/section-1271.3.Federal regulation. Carries in this article: PRP is a blood component outside the HCT/P definition.
- 46.U.S. Food and Drug Administration. 21 CFR 1271.10(a), criteria for regulation solely under section 361 of the PHS Act. ecfr.gov/current/title-21/section-1271.10.Federal regulation. Carries in this article: the four criteria (minimal manipulation, homologous use, no combination, and systemic-effect or autologous conditions) that cell products must meet.
- 47.U.S. Food and Drug Administration. Product Classification database, product code ORG: platelet and plasma separator for bone graft handling; 21 CFR 864.9245, Class II, 510(k). accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=ORG.Carries in this article: the cleared indication of PRP preparation systems.
- 48.U.S. Food and Drug Administration. Consumer Alert on Regenerative Medicine Products Including Stem Cells and Exosomes. Content current as of April 2024. fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes.Carries in this article: there are no FDA-approved exosome products; blood-forming cord blood cells are the approved stem cell products.
- 49.U.S. Food and Drug Administration. Public Safety Notification on Exosome Products. December 6, 2019. fda.gov/vaccines-blood-biologics/safety-availability-biologics/public-safety-notification-exosome-products.Carries in this article: exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products.
- 50.U.S. Food and Drug Administration. FDA warns against use of energy-based devices to perform vaginal rejuvenation or vaginal cosmetic procedures. Safety communication, July 30, 2018. fda.gov.Carries in this article: safety and effectiveness of energy-based devices for these procedures had not been established, context for combined protocols.