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

Open, Non-comparative, Pilot Study to Evaluate the Safety and Efficacy of Intraovarian Growth Factor-rich Plasma in Patients With Low Ovarian Reserve

We will try injecting plasma rich in growth factors (PRGF) into the ovaries of women with low ovarian reserve to see if it improves ovarian reserve markers and IVF lab outcomes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 50 Years
• Sex: Female
• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz (Academic / other)
• Locations: 1 site (Madrid)
• Trial ID: NCT06975683 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Women of childbearing age in POSEIDON groups 3 or 4 (AMH < 1.2 ng/ml or AFC < 5), with at least one ovary, infertility longer than one year, and able to undergo ovarian access and IVF are the intended participants.

Not a fit: Women with clinical ovarian insufficiency or failure, ongoing pregnancy, identified genetic causes of ovarian failure, IgA deficiency, pelvic adhesions preventing safe ovarian access, or on chronic aspirin/NSAIDs/anticoagulants may be ineligible or unlikely to benefit.

Why it matters

Potential benefit: If successful, intraovarian PRGF could improve ovarian reserve markers, enhance IVF laboratory outcomes, and potentially increase pregnancy rates for women with low ovarian reserve.

How similar studies have performed: Small observational studies and pilot reports have suggested PRGF can improve ovarian reserve markers and some IVF parameters, but larger randomized trials are still lacking.

Eligibility criteria

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 this trial is running

Madrid

• Hospital Universitario Fundación Jiménez Diaz — Madrid, Spain (Recruiting)

Study contacts

• Study coordinator: Carlos Javier Valdera Simbron

Conditions Low Ovarian Reserve