Actively Recruiting
Investigating Reactivation of Ovarian Function Through Autologous PRP Intra-ovarian Infusion in Menopausal Women to Promote Follicle Growth and Hormonal Improvement
Led by Genesis Athens Clinic · Updated on 2024-12-27
100
Participants Needed
1
Research Sites
375 weeks
Total Duration
On this page
Sponsors
G
Genesis Athens Clinic
Lead Sponsor
N
National and Kapodistrian University of Athens
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of autologous platelet-rich plasma (PRP) intra ovarian infusion on restoring ovarian function and promoting follicle development in menopausal women aged 45 to 55. This study is a triple-blind randomized controlled trial focusing on women experiencing menopause with amenorrhea for at least 12 months. PRP, derived from the patient's own blood and enriched with growth factors, has been used in other medical fields for tissue healing, but its role in ovarian rejuvenation and endometrial regeneration is still under investigation. Participants will receive either autologous PRP intra ovarian infusion or autologous platelet-free plasma (PFP) intra ovarian infusion as a comparison. The procedures involve infusing these biological preparations directly into the ovaries. Prior to recruitment, participants must have stopped any complementary or hormone treatments for at least three months. The trial is conducted in phases 2 and 3 to assess the treatment's effectiveness and safety. During the study, researchers will monitor the restoration of the menstrual cycle over three months and measure serum follicle-stimulating hormone (FSH) levels monthly during the follow-up period. Participants will be assessed for ovarian function and hormonal profiles. The study requires compliance with all study procedures and careful monitoring of reproductive health and hormone levels throughout the trial.
CONDITIONS
Official Title
Autologous PRP Intra Ovarian Infusion to Restore Ovarian Function in Menopausal Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 45-55 years old
- Amenorrhea for at least 12 months
- 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
You will not qualify if you...
- Any pathological disorder related to reproductive system anatomy
- Previous POI diagnosis
- Abnormal karyotype
- Endometriosis
- Adenomyosis
- Fibroids and adhesions
- Infections in reproductive system
- Current or previous diagnosis of reproductive system cancer
- History of familiar cancer in reproductive system
- Severe male factor infertility
- Prior referral for PGT
- Ovarian inaccessibility
- Endocrinological disorders (Hypothalamus-Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome)
- BMI >30 kg/m2 or BMI <18.5 kg/m2
- Systematic autoimmune disorders
AI-Screening
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Trial Site Locations
Total: 1 location
1
Genesis AC
Athens, Greece, 15232
Actively Recruiting
Research Team
M
Mara Simopoulou, PhD
A
Agni Pantou, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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