Ovarian PRP Injection for Activating Follicles
The Efficacy and Safety of Intra-ovarian PRP Injection Within a Prospective, Single-blinded, Placebo-controlled, Randomized, Clinical Superiority Trial in Subjects With Low Ovarian Reserve/Expected Poor Ovarian Response
This study is testing whether an injection of platelet-rich plasma can help women with low ovarian reserve produce more eggs for IVF or ICSI compared to a saline solution.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 42 Years |
| Sex | Female |
| Sponsor | University of Luebeck Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Luebeck, Schleswig-Holstein) |
| Trial ID | NCT05279560 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of a single intra-ovarian injection of platelet-rich plasma (PRP) compared to a saline solution in women with low ovarian reserve who are planning to undergo IVF or ICSI. The study aims to increase the number of oocytes available for fertilization by activating dormant follicles in the ovaries. Participants will be monitored for pain and quality of life post-procedure, with long-term follow-ups scheduled at 1, 2, and 5 years after the intervention. The trial is designed to address the challenges of age-related infertility and premature ovarian insufficiency.
Who should consider this trial
Good fit: Ideal candidates for this study are women with a serum AMH level of less than 0.5 ng/ml and an antral follicular count of 5 or fewer, who are planning to undergo IVF or ICSI.
Not a fit: Patients who have previously retrieved four or more cumulus-oocyte-complexes in IVF cycles may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance fertility options for women with low ovarian reserve, potentially increasing their chances of conception.
How similar studies have performed: While the use of PRP in reproductive medicine is emerging, this specific approach to follicular activation is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 endometriosis (stage III-IV) * Ovaries located outside the inner pelvis * Presence of unilateral or bilateral hydrosalpinx * Relevant endocrine disorders such as hypothalamic-pituitary disorder or thyroid dysfunction (except substituted Hashimoto's thyroiditis or latent hypothyroidism) * Relevant thrombophilic disorder * Contraindication for pregnancy * Contraindication for transvaginal ovarian puncture (such as previous major lower abdominal surgery and known severe pelvic adhesion) * Uterine malformations or pathologies (such as sub mucosal fibroid(s), endometrial hyperplasia, endometrial fluid accumulation, or endometrial adhesions) * Mental disability or any other lack of fitness, in the investigator's opinion, to preclude subjects in or to complete the study
Where this trial is running
Luebeck, Schleswig-Holstein
- University of Luebeck — Luebeck, Schleswig-Holstein, Germany (Recruiting)
Study contacts
- Principal investigator: Georg Griesing, MD — University of Luebeck
- Study coordinator: Georg Griesinger, MD
- Email: georg.griesinger@uni-luebeck.de
- Phone: +49 451-500-41950
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.