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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04487925
Other study ID # BC-09933
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 25, 2022
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source University Hospital, Ghent
Contact Sara Somers, MSc
Phone 0032 9 332 30 48
Email studieco.vrouwenkliniek@uzgent.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 208
Est. completion date December 31, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 44 Years
Eligibility Inclusion Criteria: - 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). Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
A single Gonadotropin-Releasing Hormone (GnRH) antagonist corifollitropin alfa (CFA) stimulation
CFA will be administered in combination with Follitropin beta.
Up to three modified natural cycles with Follitropin beta.
Follitropin beta in a low dose will be given.

Locations

Country Name City State
Belgium University Hospital Ghent Gent

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Other The probability of having an ongoing pregnancy 6 to 8 weeks gestational age
Other The time until ongoing pregnancy 6 to 8 weeks gestational age
Primary Number of good quality blastocysts after CFA stimulation vs. after a first MNC On fifth day of embryonal development
Secondary Number of good quality blastocysts after CFA stimulation vs. after a second or third MNC On fifth day of embryonal development
Secondary The relative number of blastocysts after ART, relative to the number of oocytes On fifth day of embryonal development
Secondary The probability of having at least one blastocyst of good quality after ART On fifth day of embryonal development
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