RecruitingPhase 2Phase 3NCT03937661
Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders
Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Poor Responders
Sponsor
Genesis Athens Clinic
Enrollment
100 participants
Start Date
May 6, 2019
Study Type
INTERVENTIONAL
Conditions
Summary
Autologous PRP intra ovarian infusion may improve ovarian response, patients' hormonal profile as well as fresh embryo transfer (ET)-ICSI cycles' outcome in patients presenting with Poor Ovarian Response (POR).
Eligibility
Sex: FEMALEMin Age: 35 YearsMax Age: 47 Years
Inclusion Criteria6
- Poor Ovarian Response according to Bologna Criteria (fulfilling 2 out of 3 of the following)
- Age ≥ 40 years
- AMH \< 1.1 ng/ml OR AFC \< 7
- ≤ 3 oocytes with a conventional stimulation protocol)
- 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 Criteria15
- Any pathological disorder related to reproductive system anatomy
- Cycle irregularities
- 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 -Endocrinological disorders (Hypothalamus-
- Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome)
- BMI\>30 kg/m2 or BMI\<18.5 kg/m2
- Systematic autoimmune disorders
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Interventions
BIOLOGICALPRP
Autologous PRP intra ovarian infusion
BIOLOGICALPlacebo
Autologous PFP intra ovarian infusion
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03937661
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