Open, Non-comparative Pilot Study to Evaluate the Safety and Efficacy of Intraovarian Plasma Rich… (NCT06975683) | Clinical Trial Compass
RecruitingNot Applicable
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
Spain50 participantsStarted 2025-05-30
Plain-language 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 and IVF-ICSI laboratory results before and after PRGF infusion.
Secondary Objectives
* To compare pre- and post-treatment pregnancy rates.
* To collect complications associated with the application of intraovarian PRGF. General Outline of the Study VISIT 1
* Patient Selection
* Confirm that he/she has all the analyses and variables to be studied.
* Signing of Informed Consent
* Usual IVF protocol (1st IVF cycle) VISIT 2
* Instillation of intraovarian PRGF on the day of the puncture of the 1st IVF cycle in the FJD VISIT 3
* Analytical control at 4 weeks VISIT 4
* Analytical control at 8 weeks VISIT 5
* In case of failure to achieve gestation Start of 2nd cycle of IVF
Who can participate
Age range
18 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of cycles cancelled pre-puncture
Timeframe: Day 1
2
Ovarian reserve markers
Timeframe: Day 1 vs visit 4 weeks
3
Number of cycles cancelled post-puncture
Timeframe: visit 4 weeks and visit 8 weeks
4
Number of oocytes recovered
Timeframe: visit 4 weeks and visit 8 weeks
5
Number of MII (metaphase II stage oocyte) on the day of the puncture
Timeframe: visit 2, day of the puncture (from the first day of menstruation, approximately 22 days later)
6
Number of fertilised oocytes
Timeframe: visit 4 weeks and visit 8 weeks
7
Number of embryos obtained per EOC (ovarian stimulation) cycle
Timeframe: visit 4 weeks and visit 8 weeks
8
Trial details
NCT IDNCT06975683
SponsorInstituto de Investigación Sanitaria de la Fundación Jiménez Díaz