Status:
RECRUITING
Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients
Lead Sponsor:
Genesis Athens Clinic
Collaborating Sponsors:
National and Kapodistrian University of Athens
Conditions:
Menopause, Premature
Menopause Related Conditions
Eligibility:
FEMALE
25-39 years
Phase:
PHASE2
PHASE3
Brief Summary
Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.
Detailed Description
This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on reactivating ovarian functionality and on promoting folliculogenes...
Eligibility Criteria
Inclusion
- Age \< 40 years, presenting with amenorrhea or menstrual cycle irregularities for at least four months, and elevated FSH levels \>25 IU/L recorded on two occasions \>4 weeks apart
- Normal Karyotype: 46, XX
- 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
- Any pathological disorder related to reproductive system anatomy
- AMH \> 8 pmol/L
- 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
- Endocrinological disorders (Hypothalamus-Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome)
- BMI\>30 kg/m2 or BMI\<18.5 kg/m2
- Systematic autoimmune disorders
Key Trial Info
Start Date :
July 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04031456
Start Date
July 30 2019
End Date
July 30 2026
Last Update
December 24 2024
Active Locations (1)
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1
Genesis AC
Athens, Greece, 15232