NCT06142708

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)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

November 9, 2023

Last Update Submit

November 20, 2023

Conditions

Ovarian StimulationHuman Chorionic GonadotropinOocyte Donors

Keywords

GnRH agonistDual triggerOocyte Donors

Outcome Measures

Primary Outcomes (3)

  • Oocyte maturation rate

    Number of metaphase II oocytes per total number of oocytes retrieved in oocyte pick-up day

    18 months prospective trial

  • Fertilization rate

    number of 2PN embryos per total number of MII oocytes fertilised

    18 months prospective trial

  • Blastulation rate

    Number of blastocysts up to day 6 per number of fertilised 2PN embryos

    18 months prospective trial

Secondary Outcomes (3)

  • Number of recipients per donor cycle

    18 months prospective trial

  • Ongoing Pregnancy Rate

    28 months prospective trial

  • Live Birth Rate

    28 months prospective trial

Study Arms (2)

Dual trigger (GnRH-agonist plus hCG)

EXPERIMENTAL

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)

Gn-RH-agonist only trigger

ACTIVE COMPARATOR

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

Drug: GnRH-agonist only trigger

Interventions

Dual trigger (human chorionic gonadotropin plus GnRH-agonist)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

Dual trigger (GnRH-agonist plus hCG)
GnRH-agonist only triggerDRUG

GnRH-agonist only will be used for final maturation

Gn-RH-agonist only trigger

Eligibility Criteria

Age20 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOocyte donors in IVF treatment
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Oocyte donors which are at risk for development of ovarian hyperstimulation syndrome (OHSS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Embryolab Fertility Clinic

Thessaloniki, 55133, Greece

RECRUITING

MeSH Terms

Interventions

Chorionic GonadotropinGonadotropin-Releasing Hormone

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteinsPituitary Hormone-Releasing HormonesHypothalamic HormonesNeuropeptidesOligopeptidesNerve Tissue Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Obstetrician Gynaecologist - Clinical Director

Study Record Dates

First Submitted

November 9, 2023

First Posted

November 21, 2023

Study Start

November 1, 2023

Primary Completion

April 1, 2025

Study Completion

February 1, 2026

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

At the trial completion IPD are to be shared with researchers from ART Fertility Clinics for statistical analysis

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
at the end of study as already submitted

Locations

GR(1)