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

Ovarian Stimulation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06142708
• Other study ID #: 012023
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: February 2026

Study information

• Verified date: November 2023
• Source: Embryolab Fertility Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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 information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Oocyte Donors
• Ovarian Stimulation

Intervention

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
• GnRH-agonist only trigger
GnRH-agonist only will be used for final maturation

Locations

Country	Name	City	State
Greece	Embryolab Fertility Clinic	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Embryolab Fertility Clinic	ART Fertility Clinics LLC

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oocyte maturation rate	Number of metaphase II oocytes per total number of oocytes retrieved in oocyte pick-up day	18 months prospective trial
Primary	Fertilization rate	number of 2PN embryos per total number of MII oocytes fertilised	18 months prospective trial
Primary	Blastulation rate	Number of blastocysts up to day 6 per number of fertilised 2PN embryos	18 months prospective trial
Secondary	Number of recipients per donor cycle	The number of recipients matched per donor	18 months prospective trial
Secondary	Ongoing Pregnancy Rate	number of pregnancies with positive fetal heart per number of embryotransfers performed	28 months prospective trial
Secondary	Live Birth Rate	number of live births per number of embryotransfers performed	28 months prospective trial