NCT04487925

Brief Summary

This is a prospective, randomized, single center, phase 4 controlled trial. The study will compare the efficacy of two different strategies for the management of predicted poor response patients under stimulation for IVF/ICSI: up to three MNC cycles (group 1) versus a single GnRH antagonist CFA (group 2).

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
208

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2022

Typical duration for phase_4

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 25, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

2.7 years

First QC Date

July 22, 2020

Last Update Submit

May 8, 2024

Conditions

Ovarian ReservePoor RespondersIVF

Outcome Measures

Primary Outcomes (1)

  • Number of good quality blastocysts after CFA stimulation vs. after a first MNC

    On fifth day of embryonal development

Secondary Outcomes (3)

  • Number of good quality blastocysts after CFA stimulation vs. after a second or third MNC

    On fifth day of embryonal development

  • The relative number of blastocysts after ART, relative to the number of oocytes

    On fifth day of embryonal development

  • The probability of having at least one blastocyst of good quality after ART

    On fifth day of embryonal development

Other Outcomes (2)

  • The probability of having an ongoing pregnancy

    6 to 8 weeks gestational age

  • The time until ongoing pregnancy

    6 to 8 weeks gestational age

Study Arms (2)

Up to 3 modified natural cycles

ACTIVE COMPARATOR
Drug: Up to three modified natural cycles with Follitropin beta.

Controlled ovarian stimulation

EXPERIMENTAL
Drug: A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation

Interventions

A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulationDRUG

CFA will be administered in combination with Follitropin beta.

Controlled ovarian stimulation
Up to three modified natural cycles with Follitropin beta.DRUG

Follitropin beta in a low dose will be given.

Up to 3 modified natural cycles

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Informed consent form (ICF) dated and signed.
  • Age ≥18 and \<45 years old.
  • Body Mass Index (BMI) ≥18.5 Kg/m² and \<35 Kg/m².
  • Regular menstrual cycles (between 21 and 35 days).
  • Two ovaries present.
  • Current pregnancy wish.
  • Poor responders as defined according to the POSEIDON criteria:
  • POSEIDON Group 3: patients \< 35 years with poor ovarian reserve pre-stimulation parameters (AFC \<5 or AMH \<1.2 ng/mL); POSEIDON Group 4: patients ≥35 years with poor ovarian reserve pre-stimulation parameters (AFC \<5 or AMH \<1.2 ng/mL).

You may not qualify if:

  • Simultaneous participation in another clinical study.
  • Untreated and uncontrolled thyroid dysfunction.
  • Tumors of the ovary, breast, uterus, pituitary or hypothalamus.
  • Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
  • Ovarian cysts or enlarged ovaries.
  • Malformations of the reproductive organs.
  • Current use of oral contraceptives, anti-psychotics, anti-epileptics or chemotherapy.
  • Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin).
  • Patients who undergo preimplantation genetic testing (PGT), fertility preservation or oocyte donation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

RECRUITING

MeSH Terms

Interventions

Gonadotropin-Releasing Hormonefollitropin beta

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Dominic Stoop, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Somers, MSc

CONTACT

0032 9 332 30 48studieco.vrouwenkliniek@uzgent.be

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2020

First Posted

July 27, 2020

Study Start

January 25, 2022

Primary Completion

September 30, 2024

Study Completion

December 31, 2024

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)