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

What Was Tested

This registered not phased trial tested hCG (human chorionic gonadotropin).

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).

It had two arms (groups): Dual trigger (GnRH-agonist plus hCG) (experimental) and Gn-RH-agonist only trigger (active comparator).

Participants in this arm will be administered a GnRH-agonist trigger plus hCG (dual trigger) for final maturation.

Participants in this arm will be administered a GnRH-agonist trigger only for final maturation.

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

The registry lists 80 planned participants were the target.

It was open to women only aged from 20 years up to 30 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: BMI: 18 - 25. 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.

The full record lists 8 inclusion and 1 exclusion criteria; among the exclusions: oocyte donors which are at risk for development of ovarian hyperstimulation syndrome (ohss).

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Because people in this hCG (human chorionic gonadotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The hCG (human chorionic gonadotropin) group and the comparison group ran side by side rather than switching.

Being open-label, the hCG (human chorionic gonadotropin) study did not mask who received what.

It started in 2023-11-01 with completion listed for 2025-04.

It ran at 1 site in Greece.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Oocyte maturation rate (time frame: 18 months prospective trial). Fertilization rate (time frame: 18 months prospective trial). Blastulation rate (time frame: 18 months prospective trial).

It also tracked 3 secondary outcomes, for example Number of recipients per donor cycle, Ongoing Pregnancy Rate and Live Birth Rate.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of hCG (human chorionic gonadotropin) in 80 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.