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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

NCT ID: NCT06142708

Last Updated: 2023-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-02-28

Brief Summary

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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

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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

Conditions

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Ovarian Stimulation Human Chorionic Gonadotropin Oocyte Donors

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dual trigger (GnRH-agonist plus hCG)

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

Group Type EXPERIMENTAL

Dual trigger (human chorionic gonadotropin plus GnRH-agonist)

Intervention Type DRUG

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

Gn-RH-agonist only trigger

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

Group Type ACTIVE_COMPARATOR

GnRH-agonist only trigger

Intervention Type DRUG

GnRH-agonist only will be used for final maturation

Interventions

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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

Intervention Type DRUG

GnRH-agonist only trigger

GnRH-agonist only will be used for final maturation

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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ART Fertility Clinics LLC

OTHER

Sponsor Role collaborator

Embryolab Fertility Clinic

OTHER

Sponsor Role lead

Responsible Party

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Nikolaos Christoforidis

Consultant Obstetrician Gynaecologist - Clinical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Embryolab Fertility Clinic

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Facility Contacts

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Nikolaos Christoforidis, MD

Role: primary

[email protected]
+302310474747

Dimitrios Michalakis, MD

Role: backup

[email protected]

Other Identifiers

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012023

Identifier Type: -

Identifier Source: org_study_id