Clinical trial

The Effect of Dual Trigger (GnRH Agonist + hCG) for Final Maturation in Oocyte Donors With History of a Previous Cycle With Suboptimal Response to GnRH Agonist Only Trigger

Name
012023
Description
The goal of this clinical trial is to compare GnRH-agonist trigger with dual GnRH-agonist and HCG trigger in oocyte donors. The main questions it aims to answer are: * Maturation rate (Metaphase II/ Total number of COCs collected) * Fertilization rate * Embryo quality day 3 * Fragmentation rate embryo day 3 * Blastulation rate (Day5/6/7) * Quality of blastocyst (Gardner criteria) Participants will undergo controlled ovarian stimulation with a GnRH antagonist protocol Researchers will compare the effects of final maturation with GnRH-agonist trigger to a dual trigger (hCG and GnRH-a)
Trial arms
Trial start
2023-11-01
Estimated PCD
2025-04-01
Trial end
2026-02-01
Status
Recruiting
Treatment
Dual trigger (human chorionic gonadotropin plus GnRH-agonist)
Human chorionic gonadotropin will be added to GnRH-agonist as a dual trigger in participants previously having had a suboptimal response to GnRH-agonist trigger only
Arms:
Dual trigger (GnRH-agonist plus hCG)
GnRH-agonist only trigger
GnRH-agonist only will be used for final maturation
Arms:
Gn-RH-agonist only trigger
Size
80
Primary endpoint
Oocyte maturation rate
18 months prospective trial
Fertilization rate
18 months prospective trial
Blastulation rate
18 months prospective trial
Eligibility criteria
Inclusion Criteria: * BMI: 18 - 25 * AMH: 1-3ng/ml * AFC: 15 * Peak E2 in previous ovarian stimulation cycle: \< 4000 pg/ml * Ovarian response in first stimulation cycle: \< 20 follicles over 10mm in total, at time of triggering * Peak E2 in study cycle: \< 4000 pg/ml * Suboptimal response to trigger medication at first stimulation cycle * Male age \< 50 years old with normospermia Exclusion Criteria: * Oocyte donors which are at risk for development of ovarian hyperstimulation syndrome (OHSS)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}
Updated at
2023-11-21

1 organization

2 products

3 indications

Indication
hCG
Indication
Oocyte Donation