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

Study Overview
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Brief Summary
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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)

Detailed Description
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Final oocyte maturation is a critical step in the process of the Assisted Reproductive Technology (ART) treatment and has a certain impact on oocyte yield and oocyte competency. There are three different types of trigger: hCG, GnRH-agonist or dual trigger (hCG and GnRH-agonist combined), and the choice depends on the ovarian stimulation protocol, the ovarian response and on the clinical standard of the IVF clinic. As oocyte donors are at high risk for OHSS, a GnRH-agonist trigger (GnRH-a) is the most commonly used modality for triggering final maturation. However, a certain number of oocyte donors may have a suboptimal response to GnRH-a trigger only, with a yield of oocytes less than the 10th percentile, with a clear negative impact on oocyte efficiency and competency. This study aims to evaluate whether oocyte competence can be improved in oocyte donors with a previously suboptimal response to GnRH-a, by using a dual trigger in a subsequent ovarian stimulation cycle, in which hCG is added to the GnRH-agonist for final maturation

Official Title
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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

Conditions
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Ovarian Stimulation, Human Chorionic Gonadotropin, Oocyte Donors

Intervention / Treatment
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* Drug: Dual trigger (human chorionic gonadotropin plus GnRH-agonist)
* Drug: GnRH-agonist only trigger


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual trigger (GnRH-agonist plus hCG)<br>Participants in this arm will be administered a GnRH-agonist trigger plus hCG (dual trigger) for final maturation | Drug: Dual trigger (human chorionic gonadotropin plus GnRH-agonist)<br>* 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<br>|
| Active Comparator: Gn-RH-agonist only trigger<br>Participants in this arm will be administered a GnRH-agonist trigger only for final maturation | Drug: GnRH-agonist only trigger<br>* GnRH-agonist only will be used for final maturation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oocyte maturation rate | Number of metaphase II oocytes per total number of oocytes retrieved in oocyte pick-up day | 18 months prospective trial | 
| Fertilization rate | number of 2PN embryos per total number of MII oocytes fertilised | 18 months prospective trial | 
| Blastulation rate | Number of blastocysts up to day 6 per number of fertilised 2PN embryos | 18 months prospective trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of recipients per donor cycle | The number of recipients matched per donor | 18 months prospective trial | 
| Ongoing Pregnancy Rate | number of pregnancies with positive fetal heart per number of embryotransfers performed | 28 months prospective trial | 
| Live Birth Rate | number of live births per number of embryotransfers performed | 28 months prospective trial | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GnRH agonist, Dual trigger, Oocyte Donors