Status:
ACTIVE_NOT_RECRUITING
Ovarian PRP (Platelet Rich Plasma) Injection for Follicular Activation
Lead Sponsor:
University of Luebeck
Conditions:
Premature Ovarian Insufficiency
Infertility, Female
Eligibility:
FEMALE
18-42 years
Phase:
NA
Brief 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) i...
Detailed Description
Age-related infertility and premature loss of ovarian reserve has become a major challenge for ART professionals as the the average age at first child wish has dramatically increased over time. Under ...
Eligibility Criteria
Inclusion
- 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
- ≥ 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
Key Trial Info
Start Date :
March 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2030
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT05279560
Start Date
March 17 2022
End Date
June 30 2030
Last Update
June 4 2025
Active Locations (1)
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1
University of Luebeck
Lübeck, Schleswig-Holstein, Germany, 23562