A randomized comparison of one controlled ovarian stimulation with corifollitropin alfa (CFA) versus up to three modified natural cycles (MNC) in expected and established poor responders

Universitair Ziekenhuis Gent1 site in 1 country300 target enrollmentJune 27, 2024

DrugsPuregon 900 IU/1.08 mL solution for injection Ovitrelle 250 micrograms/0.5 mL solution for injection in pre-filled syringe Elonva 150 micrograms solution for injection Puregon 300 IU/0.36 mL solution for injection Orgalutran 0.25 mg/0.5 mL solution for injection Puregon 600 IU/0.72 mL solution for injection Puregon 150 IU/0.18 mL solution for injection

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Not specified
Sponsor: Universitair Ziekenhuis Gent
Enrollment: 300
Locations: 1
Primary Endpoint: the probability of having at least one good quality blastocyst after ART (on the day of embryo transfer) (binary endpoint).
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

to compare the probability of having at least one good quality blastocyst after CFA stimulation versus the probability of having at least one good quality blastocyst after a first MNC, in women with a clinical indication for ART and an expected low response to ovarian stimulation. Good quality is defined by the Gardner score 5AA, 5AB or 5BA.

Registry

euclinicaltrials.eu

Start Date

June 27, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

Universitair Ziekenhuis Gent

Responsible Party

Principal Investigator

Wijnant Kathleen

Scientific

Universitair Ziekenhuis Gent

Eligibility Criteria

Inclusion Criteria

•women with a clinical indication for ART with an expected low response to ovarian stimulation. Expected low prognosis will be defined according to the POSEIDON classification, which stratifies patients according to whether they have an unexpected (groups 1 and 2) or expected (groups 3 or 4) inappropriate ovarian response to gonadotropin stimulation. This trial only includes patients fulfilling the criteria of groups 3 or 4: • 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*) * AMH value should not be older than 12 months.
•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
•Single embryo transfer (SET)

Exclusion Criteria

•Basal FSH > 20 IU/L in the last 12 months
•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
•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

Outcomes

Primary Outcomes

the probability of having at least one good quality blastocyst after ART (on the day of embryo transfer) (binary endpoint).

Secondary Outcomes

the relative number of blastocyts after ART (on the day of embryo transfer), relative to the number of oocytes (rate)
the probability of having at least one blastocyst of good quality after ART (on the day of embryo transfer) (binary endpoint)
the probability of having an ongoing pregnancy which is defined as 6 to 8 weeks gestational age (binary endpoint) o Related sensitivity endpoint:, as confirmed by ultrasound (time to event)