Ovarian PRP (Platelet Rich Plasma) Injection for Follicular Activation
Germany114 participantsStarted 2022-03-17
Plain-language summary
The primary objective is to investigate the efficacy, defined as an increase in oocyte numbers upon ovarian stimulation, and safety of a single intra-ovarian PRP injection vs. saline solution (NaCl) injection (Placebo) transvaginally or laparoscopically for follicular activation in patients with child wish and with low ovarian reserve/expected poor ovarian response planning to undergo IVF or ICSI using own eggs. Pain score as numerical rating score and validated quality of life questionnaire will be requested after the procedure. Longterm follow-up of all participants will be performed 1, 2 and 5 years after end of study.
Who can participate
Age range
18 Years – 42 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:
* Serum AMH \< 0.5 ng/ml (at screening visit and in the absence of OC or sex-steroid intake)
* Antral follicular count (AFC) in both ovaries ≤ 5 (at screening visit and in the absence of OC or sex-steroid intake)
* Spontaneous cycle, menstrual cycle length 21-35 days
* Body mass index (BMI) ≥18 kg/m2 and ≤38 kg/m2
* Both ovaries must be visible by transvaginal ultrasound examination
* Both ovaries must be judged accessible by transvaginal puncture
* Indication for IVF or ICSI treatment
* Willingness to participate and provide written consent prior to initiation of any study-related procedures
* The subject and male partner must agree to participate in the infant follow-up if she becomes pregnant
* The subject must be able to communicate well with the investigator and research staff and to comply with the requirements of the study protocol.
Exclusion Criteria:
* ≥ four cumulus-oocyte-complexes (COCs) retrieved in a previous IVF cycles with a conventional stimulation protocol (within 6 months before enrollment)
* Serum value of FSH ≥25 IU/l (within 12 months measured in the absence of OC or hormone replacement intake)
* Thrombocytopenia defined as \< 100.000 platelets/µl at screening
* Oral contraceptive or sex steroid intake within 1 month prior to enrollment
* Presence of structural or numerical chromosomal abnormality in cytogenetic analysis
* Relevant autoimmune disease
* History of malignancy and systemic chemotherapy or pelvic radiation
* Severe end…
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
Ovarian response
Timeframe: 34-36 hours following hCG administration at the end of ovarian stimulation