this study will compare the efficacy of two different strategies for the management of predicted low prognosis patients under stimulation for IVF/ICSI: up to three MNCs (Modified Natural Cycle) (control group) versus a single GnRH antagonist CFA (corifollitropin alfa) (intervention group). The study population is aimed at women with a clinical indication for Assisted Reproductive Technology (ART) with an expected low response to ovarian stimulation.
Conditions
Interventions
Trade Name: ELONVA
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CORIFOLLITROPIN ALFA
CAS Number: 195962-23-3
Current Sponsor code: CORIFOLLITROPIN ALFA
Concentration unit: µg/ml mi
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The trial only includes 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is 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.;Secondary Objective: Secondary objectives are 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 second or third MNC, in women with a clinical indication for ART and an expected low response to ovarian stimulation. Further secondary objectives are to compare A.One cycle of CFA versus B.two, or up to three MNCs With respect to -the relative number of blastocysts after ART, relative to the number of oocytes -the probability of having at least one blastocyst of good quality after ART -the probability of having an ongoing pregnancy -the time until ongoing pregnancy in women with a clinical indication for ART and an expected low response to ovarian stimulation. ;Primary end point(s): The primary end point is the probability of having at least one good quality blastocyst after ART (on the day of embryo transfer) ;Timepoint(s) of evaluation of this end point: on the day of embryo transfer | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points are - 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) ;Timepoint(s) of evaluation of this end point: - relative number of blastocyts after ART (on the day of embryo transfer) - probability of having at least one blastocyst of good quality after ART (on the day of embryo transfer) - the probability of having an ongoing pregnancy which is defined as 6 to 8 weeks gestational age | — |
Countries
Belgium
Contacts
Public ContactHiruz CTU
Ghent University Hospital
Outcome results
None listed