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
- Ovarian StimulationHuman Chorionic GonadotropinOocyte Donors
- Interventions
- Drug: Dual trigger (human chorionic gonadotropin plus GnRH-agonist)Drug: GnRH-agonist only trigger
- Registration Number
- NCT06142708
- Lead Sponsor
- Embryolab Fertility Clinic
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 80
- 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
- Oocyte donors which are at risk for development of ovarian hyperstimulation syndrome (OHSS)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dual trigger (GnRH-agonist plus hCG) Dual trigger (human chorionic gonadotropin plus GnRH-agonist) Participants in this arm will be administered a GnRH-agonist trigger plus hCG (dual trigger) for final maturation Gn-RH-agonist only trigger GnRH-agonist only trigger Participants in this arm will be administered a GnRH-agonist trigger only for final maturation
- Primary Outcome Measures
Name Time Method Blastulation rate 18 months prospective trial Number of blastocysts up to day 6 per number of fertilised 2PN embryos
Oocyte maturation rate 18 months prospective trial Number of metaphase II oocytes per total number of oocytes retrieved in oocyte pick-up day
Fertilization rate 18 months prospective trial number of 2PN embryos per total number of MII oocytes fertilised
- Secondary Outcome Measures
Name Time Method Number of recipients per donor cycle 18 months prospective trial The number of recipients matched per donor
Ongoing Pregnancy Rate 28 months prospective trial number of pregnancies with positive fetal heart per number of embryotransfers performed
Live Birth Rate 28 months prospective trial number of live births per number of embryotransfers performed
Trial Locations
- Locations (1)
Embryolab Fertility Clinic
🇬🇷Thessaloniki, Greece