Actively Recruiting

Phase 2
Phase 3
Age: 45Years - 55Years
FEMALE
Healthy Volunteers
ID03916978

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

Age: 45Years - 55Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

Frequently Asked Questions

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Investigating Reactivation of Ovarian Function Through Autologous PRP Intra-ovarian Infusion in Menopausal Women to Promote Follicle Growth and Hormonal Improvement | DecenTrialz