Controlled ovarian hyperstimulation to induce the development of multiple follicles for assisted reproductive technologies (ART) MedDRA version: 9.1 Level: LLT Classification code 10021926 Term: Infertility
Conditions
Interventions
Product Name: MENOPUR
Product Code: MENOPUR
Pharmaceutical Form: Powder and solvent for solution for injection
Trade Name: PUREGON
Pharmaceutical Form: Solution for injection
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for ICSI, with the primary diagnosis of infertility being unexplained infertility or mild male factor will be included in this trial. Subjects should be 21-34 years old, have a BMI of 18-25 kg/m2, have early follicular FSH levels between 1 and 12 IU/L and antral follicle count = 10, as well as regular menstrual cycles of 24-35 days presumed to be ovulatory. Subjects must be willing to accept transfer of one blastocyst in the fresh cycle, and willing to undergo frozen embryo replacement cycles with transfer of one blastocyst per cycle within the first year after randomisation. Written informed consent must be obtained. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects with known polycystic ovarian syndrome, known endometriosis stage I-IV or diagnosed as poor responders will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Ongoing pregnancy rate after one fresh embryo replacement cycle (transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after blastocyst transfer);Main Objective: To compare MENOPUR and a recombinant FSH preparation with respect to pregnancy rates in women undergoing controlled ovarian stimulation following a GnRH antagonist protocol;Secondary Objective: - To evaluate the circulating and intrafollicular endocrine profile during stimulation with MENOPUR and recombinant FSH following a GnRH antagonist protocol - To evaluate the ovarian response as well as the oocyte, embryo and blastocyst quality associated with MENOPUR and recombinant FSH following a GnRH antagonist protocol - To evaluate the sonographic endometrial profile during stimulation with MENOPUR and recombinant FSH following a GnRH antagonist protocol - To evaluate uterine contractility during controlled ovarian stimulation with MENOPUR and recombinant FSH and its relation to implantation - To evaluate the adverse event profile of MENOPUR and recombinant FSH | — |
Countries
Belgium, Czech Republic, Poland, Spain, Sweden
Outcome results
None listed