Clinical trial NCT06142708: 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
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ovarian Stimulation
Human Chorionic Gonadotropin
Oocyte Donors
Keywords: GnRH agonist
Dual trigger
Oocyte Donors
Lead sponsor: Embryolab Fertility Clinic
Sponsor class: OTHER
Collaborators: name: ART Fertility Clinics LLC
First posted: 2023-11-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Oocyte maturation rate
timeFrame: 18 months prospective trial
measure: Fertilization rate
timeFrame: 18 months prospective trial
measure: Blastulation rate
timeFrame: 18 months prospective trial
Secondary outcomes:
measure: Number of recipients per donor cycle
timeFrame: 18 months prospective trial
measure: Ongoing Pregnancy Rate
timeFrame: 28 months prospective trial
measure: Live Birth Rate
timeFrame: 28 months prospective trial
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Embryolab Fertility Clinic
Study officials:
References: