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

Sponsor

Embryolab Fertility Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT06142708

Collaborator

ART Fertility Clinics LLC (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Ovarian Stimulation Human Chorionic Gonadotropin Oocyte Donors	Drug: Dual trigger (human chorionic gonadotropin plus GnRH-agonist) Drug: GnRH-agonist only trigger	N/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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Feb 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dual trigger (GnRH-agonist plus hCG) 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) 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
Active Comparator: Gn-RH-agonist only trigger Participants in this arm will be administered a GnRH-agonist trigger only for final maturation	Drug: GnRH-agonist only trigger GnRH-agonist only will be used for final maturation

Arm

Intervention/Treatment

Experimental: Dual trigger (GnRH-agonist plus hCG)

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)

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

Active Comparator: Gn-RH-agonist only trigger

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

Drug: GnRH-agonist only trigger

GnRH-agonist only will be used for final maturation

Outcome Measures

Primary Outcome Measures

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
Blastulation rate [18 months prospective trial]
Number of blastocysts up to day 6 per number of fertilised 2PN embryos

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 30 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Embryolab Fertility Clinic	Thessaloniki		Greece	55133

Sponsors and Collaborators

Embryolab Fertility Clinic
ART Fertility Clinics LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nikolaos Christoforidis, Consultant Obstetrician Gynaecologist - Clinical Director, Embryolab Fertility Clinic

ClinicalTrials.gov Identifier:

NCT06142708

Other Study ID Numbers:

012023

First Posted:

Nov 21, 2023

Last Update Posted:

Nov 21, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nikolaos Christoforidis, Consultant Obstetrician Gynaecologist - Clinical Director, Embryolab Fertility Clinic

GnRH agonist

Dual trigger

Oocyte Donors

Additional relevant MeSH terms:

Chorionic Gonadotropin

Prolactin Release-Inhibiting Factors

Study Results

No Results Posted as of Nov 21, 2023