🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity ◆ Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing ◆ Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich ◆ Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery ◆ Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma ◆ Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide ◆ The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany ◆ Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact ◆ Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity ◆ Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing ◆ Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich ◆ Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery ◆ Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma ◆ Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide ◆ The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany ◆ Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact ◆
Clinical Trials in Germany / NCT05279560
Active, not recruiting Not applicable

Ovarian PRP (Platelet Rich Plasma) Injection for Follicular Activation

NCT05279560 · tracked via the Priya Life Science Germany tracker
Phase
Not applicable
Started
2022-03-17
Last updated
2025-06-04

Condition(s) studied

Premature Ovarian InsufficiencyInfertility, FemaleSterility, FemalePRP

Investigational drug(s) / intervention(s)

autologous PRP (platelet rich plasma)Saline solution (NaCL) Injection

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.

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
42 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University of Luebeck Lübeck Schleswig-Holstein

More University of Luebeck trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05279560 on ClinicalTrials.gov ↗ ← All trials in Germany