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Impact of Intraovarian Injection of Platelet-Rich Plasma and Growth Factors on IVF Outcomes in Patients with Low Ovarian Reserve: A Randomized Controlled Trial
EU CTIS ID: 2024-517726-26-00
What this study is testing
Quantify the mean difference in oocytes obtained with PRFG-Endoret® compared to placebo injection.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - Women with a diagnosis of low ovarian response according to POSEIDON III/IV criteria. - Age limited to between 18 and 42 years, inclusive - Regular cycles, on a monthly basis with an interval of 24 to 35 days. - Treatments limited to a single IVF/IVF PGT-A cycle, in which there will be no oocyte/embryo accumulation. - Normal karyotypes in both partners. - Complete preoperative blood work valid for 6 months according to standard clinical practice, with a minimum platelet count >160,000/mcL. - Negative serologies for HIV, HCV, HBV and RPR less than <3 months old. In case of not having a recent test, it will be performed at the in-study research centre at no cost to the patient. - Semen with a sperm count greater than 5 million motile sperm per ejaculate or sperm donation treatments. - Both ovaries accessible for vaginal puncture - BMI >18 kg/m2
You likely can't join if
- - Diagnosis of ovarian failure or amenorrhoeic blips - Failure to meet POSEIDON III/IV criteria - Presence of autoimmune pathology, thrombophilias, use of anticoagulants or antiplatelet agents or history of cancer treatment (chemotherapy/radiotherapy) - Platelets with levels below 160xmcL, aplastic anaemia or thrombocytosis. - Presence of ovarian and/or tubal pathology; patients with a single ovary, previous ovarian surgery, hydrosalpinx, known ovarian endometrioma or dermoid cyst - BMI >35 kg/m2 - Male partner with less than 5 million total motile sperm per ejaculate and/or sample obtained by testicular biopsy. - Diagnosis of endometrial insufficiency, which is defined as endometrial thickness equal to or less than 6 mm in the previous cycle and/or presence of persistent endometrial fluid.
The study team makes the final eligibility decision.
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, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.