Status:
RECRUITING
Open, Non-comparative Pilot Study to Evaluate the Safety and Efficacy of Intraovarian Plasma Rich in Growth Factors (PRGF) in Patients With Low Ovarian Reserve
Lead Sponsor:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Conditions:
Low Ovarian Reserve
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
The use of plasma rich in growth factors (PRGF) improves ovarian reserve markers and IVF laboratory parameters in women with low ovarian reserve. Primary objective To compare ovarian reserve markers ...
Eligibility Criteria
Inclusion
- Women of childbearing age as defined by the CTFG\*.
- Women in group 3 and 4 of the POSEIDON classification for low reserve:
- POSEIDON 3: patients ˂ 35 years of age with decreased ovarian reserve (AMH \<1.2 ng/ml, AFC \<5).
- POSEIDON 4: patients ≥ 35 years with decreased ovarian reserve (AMH \<1.2 ng/ml, AFC \<5).
- Patients with at least one ovary.
- Infertility of more than 1 year duration.
- Provision of safe ovarian access on the day of the puncture.
- They agree to participate and to give their written consent.
Exclusion
- Have a diagnosis of clinical ovarian insufficiency - Patients with an ongoing pregnancy - Patients with a clinical diagnosis of ovarian failure
- Patients with ongoing pregnancy
- Current or previous IgA deficiency,
- Ovarian failure secondary to identified genetic causes.
- Presence of pelvic adhesions after abdominal surgery.
- Chronic use of aspirin, NSAIDs or anticoagulants.
- Diseases that alter platelet number or function.
- Psychiatric disorder that precludes participation in the study (including active substance abuse or dependence).
- Obesity (BMI ≥ 30).
- Current female smokers (≥ 15 cigarettes per day) - Current smoking (≥ 15 cigarettes per day)
- Patients affected by neoplastic disease
- Severe male factor infertility
Key Trial Info
Start Date :
May 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06975683
Start Date
May 30 2025
End Date
May 1 2026
Last Update
June 12 2025
Active Locations (1)
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1
Hospital Universitario Fundación Jiménez Diaz
Madrid, Spain, 28924