Using Platelet Rich Plasma to Improve Ovarian Function in Perimenopausal Women
Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Perimenopausal Women
PHASE2; PHASE3 · Genesis Athens Clinic · NCT03951194
This study is testing if injecting a special treatment made from a woman's own blood can help improve ovarian function and hormone levels in women going through perimenopause.
Quick facts
| Phase | PHASE2; PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 40 Years to 50 Years |
| Sex | Female |
| Sponsor | Genesis Athens Clinic (other) |
| Locations | 1 site (Athens) |
| Trial ID | NCT03951194 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of autologous platelet rich plasma (PRP) intra ovarian infusion in enhancing ovarian tissue functionality and hormonal profiles in perimenopausal women. The study employs a triple-blind randomized controlled trial design, comparing the effects of PRP with a placebo treatment of autologous platelet free plasma (PFP). PRP, enriched with growth factors, is hypothesized to stimulate tissue proliferation and promote folliculogenesis. The trial aims to provide insights into the potential benefits of PRP for women experiencing infertility and menstrual cycle abnormalities during perimenopause.
Who should consider this trial
Good fit: Ideal candidates are women aged 40 and older with irregular menstrual cycles and elevated FSH levels.
Not a fit: Patients with reproductive system anatomical disorders, amenorrhea, or a history of certain reproductive cancers may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve ovarian function and hormonal balance in perimenopausal women, potentially enhancing fertility.
How similar studies have performed: While PRP has shown promise in other medical fields, its application for ovarian rejuvenation is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women ≥40 years of age, presenting with cycle irregularities while fulfilling at least one of the respective two criteria: more than seven days difference in menstrual cycle duration between two consecutive cycles OR, presence of a menstrual cycle duration over sixty days and progressive elevation of FSH levels. * Discontinuation of any complementary/adjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment. * Willing to comply with study requirements Exclusion Criteria: * Any pathological disorder related to reproductive system anatomy * Amenorrhea * Endometriosis * Adenomyosis * Fibroids and adhesions * Infections in reproductive system * Current or previous diagnosis of cancer in reproductive system * History of familiar cancer in reproductive system * Severe male factor infertility * Prior referral for PGT * Ovarian inaccessibility * Previous POI diagnosis -Endocrinological disorders (Hypothalamus- * Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome) * BMI\>30 kg/m2 or BMI\<18.5 kg/m2 * Systematic autoimmune disorders
Where this trial is running
Athens
- Genesis AC — Athens, Greece (RECRUITING)
Study contacts
- Study coordinator: Mara Simopoulou, PhD
- Email: marasimopoulou@hotmail.com
- Phone: +306979234100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infertility, Female, Perimenopausal Disorder, Menstrual Cycle Abnormal