Intraovarian plasma rich in growth factors (PRGF) treatment for women with low ovarian reserve

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open, non-comparative pilot enrolls women with low ovarian reserve (POSEIDON groups 3 and 4) who are undergoing IVF. Participants receive an intraovarian injection of PRGF on the day of oocyte retrieval during their first IVF cycle. Researchers compare ovarian reserve markers (for example AMH and antral follicle count) and IVF‑ICSI laboratory results before and after the PRGF infusion, with follow-up blood tests at 4 and 8 weeks and monitoring for complications. If no pregnancy is achieved, participants may proceed to a second IVF cycle and pregnancy rates before and after treatment are also recorded.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Hospital Universitario Fundación Jiménez Diaz
  Madrid, Spain Recruiting

Study contacts

• Study coordinator: Carlos Javier Valdera Simbron
• Email: carlos.valdera@fjd.es
• Phone: 915504800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.