CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 50 enrolled
Drug / intervention
Triptorelin acetate +3 moredrug
Likely dose
Triptorelin acetate 0.1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04727684
NCT04727684Phase 4Completed

Effect of GnRH Agonist (Long Protocol) vs GnRH Antagonist (Flexible Protocol) on Oocyte Morphology in Polycystic Ovary Syndrome Patients During IVF/ICSI

Damascus University·interventional·Posted Jan 27, 2021·Updated Oct 24, 2023

In Brief

A Phase 4 clinical trial evaluating Triptorelin acetate, Cetrorelix, and 2 other interventions for In Vitro Fertilization and 3 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed Summary

Selection of developmentally competent oocytes enhances IVF efficiency. Usually, oocyte quality is determined based on its nuclear maturation and the presence of specific cytoplasmic and extracytoplasmic morphologic features. Gonadotropin-releasing hormone agonists (GnRH Agonists) and gonadotropin-releasing hormone antagonists (GnRH Antagonists) are used during controlled ovarian stimulation (COS) protocols in order to prevent premature luteinizing hormone (LH) surge and premature ovulation. However, GnRH receptors are also expressed in extra-pituitary tissues such as ovary, but it is still unknown whether the type of GnRH analogues used during COS could affect the oocyte morphology in polycystic ovary syndrome (PCOS) patients. The aim of this prospective, non-randomised, open-label, clinical trial is to compare the effects of two pituitary suppression regimens; GnRH Agonist-Long Protocol and GnRH Antagonist-Flexible Protocol on oocyte morphology in PCOS patients during IVF/ICSI.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSyria
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedJan 27, 2021
Enrollment StartAug 22, 2020
Primary CompletionFeb 15, 2022
Study CompletionMay 12, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.4 years ago

Interventions

Triptorelin acetatedrug

0.05-0.1 mg subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the cycle until the day of ovulation triggering.

Cetrorelixdrug

0.25 mg subcutaneously (SC) once daily starting from the day detecting a leading follicle diameter ≥ 14 mm until the day of ovulation triggering.

recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropindrug

Dosage adjustment according to the ovarian response.

Human Chorionic Gonadotropin (hCG)drug

Ovulation will be triggered by the administration of 10,000 IU of human chorionic gonadotropin when at least three follicles become more than 16-17 mm.