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ACTIVE NOT RECRUITING

NCT05279560

Ovarian PRP (Platelet Rich Plasma) Injection for Follicular Activation

Sponsor: University of Luebeck

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - 42 Years

Study Type

INTERVENTIONAL

Enrollment

114

Start Date

2022-03-17

Completion Date

2030-06-30

Last Updated

2025-06-04

Healthy Volunteers

Conditions

Premature Ovarian Insufficiency Infertility, Female Sterility, Female PRP

Interventions

BIOLOGICAL

autologous PRP (platelet rich plasma)

The required volume of PRP will be extracted from 60 ml of the patient's peripheral blood. Injecting PRP into the ovaries will be performed likewise to the standard operating procedure of oocyte retrieval. After centrifugation of the whole blood, 5ml PRP will be injected in each ovary intra-medullar and subcortical using a 17-gauge single lumen needle under sedation und under transvaginal ultrasound monitoring.

OTHER

Saline solution (NaCL) Injection

Injecting NaCL into the ovaries will be performed likewise to the standard operating procedure of oocyte retrieval. NaCL will be injected in each ovary intra-medullar and subcortical using a 17-gauge single lumen needle under sedation und under transvaginal ultrasound monitoring.

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

Locations (1)

University of Luebeck

Lübeck, Schleswig-Holstein, Germany