The Role of Ovarian PRP Therapy in Poseidon Poor Responders Women Undergoing ICSI Cycle
NCT ID: NCT07199868
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
102 participants
INTERVENTIONAL
2024-01-01
2025-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Material and Methods: A randomized controlled trial was conducted from Jan 2024 to Feb 2025, involving 102 Poseidon women, Participants were divided into a PRP group (n=50), who received ovarian PRP injections and a control group (n=52), who received no PRP. All participants underwent ICSI cycles, embryological and pregnancy outcomes were compared between both groups within each Poseidon group.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
2.2. Participants A total of 102 Poseidon POR women were enrolled where Inclusion criteria were infertile Poseidon groups 2, 3, 4 women with no history of chronic illness or pelvic pathology. All male partners were either normozoospermic or had mild OAT delivered fresh ejaculated samples for ICSI.
Exclusion criteria were ovarian failure due to sex chromosome abnormalities, current use of anticoagulants and history of bleeding disorders. Participants were assigned into two groups: Study group (n=50), who underwent ovarian PRP injections once or twice times within six months prior to ICSI cycle, and control group (n=52), who did not receive PRP therapy.
2.3. PRP preparation and injection Twenty mL of peripheral blood was drawing under sterile conditions using Lora PRP tubes (Modern Technology Company). Frist the blood was centrifuged at 1600 rpm for 10 minutes (soft spin). Then the plasma and superficial buffy coat were transferred into a sterile tube containing no anticoagulant and centrifuged again at 3500 rpm for 5 minutes (hard spin). The upper 2/3rd (platelet-poor plasma, PPP) were discarded, and the platelet pellets were homogenized in the lower 1/3rd of plasma to create 3 mL of platelets concentrate of 3-5 times higher than basal and injected within one hour of preparation (11). During early-mid follicular phase, using TV-US guidance and conscious sedation, 1.5 ml of PRP was injected into each ovary's subcortical layer using a 17-gauge ovum pick-up needle. A second PRP injection was administered when subsequent ORTs (AMH,AFC) and hormone levels (FSH, LH, E2) showed suboptimal results in patient's next menstrual cycles.
2.4. ICSI cycle outcomes All patients starting same COS protocol began on CD3 using (300-450 iu) of Gonal-F (r-FSH); Merck ± (u-HMG);LG in flexible antagonist protocol, (Cetrotide); Merck. Final oocyte maturation was triggered by 250 mcg r-hCG (Ovitrelle; Serono) ± 0.2 mg GnRH agonist (Decapeptyl; Merck) 35 hours before oocyte retrieval when dominant follicles reached (17-18) mm. Embryological outcomes including; MII oocytes, embryos quantity and quality were compared in both group. In all embryo transfer cycles, 2-4 embryos grade A± B of age 2-5 day were transferred. The clinical outcomes included pregnancy rate (serum β-HCG ≥100 mIU/mL), miscarriage rate (the loss of a pregnancy before 24 weeks), Live Birth rates (delivery of a living baby after 24 weeks) and overall cycle outcomes were compared in both groups.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ovarian PRP injection in poor responders
During early-mid follicular phase, using TV-US guidance and conscious sedation, 1.5 ml of PRP was injected into each ovary's subcortical layer using a 17-gauge ovum pick-up needle.
During early-mid follicular phase, using TV-US guidance and conscious sedation, 1.5 ml of PRP was injected into each ovary's subcortical layer using a 17-gauge ovum pick-up needle.
During early-mid follicular phase, using TV-US guidance and conscious sedation, 1.5 ml of PRP was injected into each ovary's subcortical layer using a 17-gauge ovum pick-up needle.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
During early-mid follicular phase, using TV-US guidance and conscious sedation, 1.5 ml of PRP was injected into each ovary's subcortical layer using a 17-gauge ovum pick-up needle.
During early-mid follicular phase, using TV-US guidance and conscious sedation, 1.5 ml of PRP was injected into each ovary's subcortical layer using a 17-gauge ovum pick-up needle.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
21 Years
49 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Karbala University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Itlal Asadi
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Itlal J AL Asadi, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics & Gynecology, College of Medicine, Karbala University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Collage of medicine
Baghdad, , Iraq
Collage of medicine
Karbala, , Iraq
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan: The role of Ovarian PRP Therapy
Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form: ICSI Cycles
Document Type: Informed Consent Form: Poseidon Poor Responders
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
non
Identifier Type: OTHER
Identifier Source: secondary_id
0009-0007-1354-0259
Identifier Type: -
Identifier Source: org_study_id