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Tests treatment safety and results for Low Ovarian Reserve
Official title 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
ClinicalTrials.gov ID: NCT06975683
What this study is testing
What is Plasma Rich in Growth Factors (PRGF)?
Plasma Rich in Growth Factors (PRGF) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for low ovarian reserve.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 and IVF-ICSI laboratory results before and after PRGF infusion.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.