COrifollitropin alfa followed by Menotropin for Poor Ovarian Responders Trial

Phase 1

Conditions: Infertility in women with poor ovarian response to stimulation for IVF/ICSI
Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

Registration Number: EUCTR2013-000583-29-BE

Lead Sponsor: niversitair Ziekenhuis Brussel

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 150

Inclusion Criteria

Patients participating in the COMPORT study will be women less than 40 years old who are considered poor ovarian responders according to the Bologna criteria (Ferrarretti et al. 2011).Eligible will be women <40 years old with at least 2 previous treatment cycles with = 3 oocytes retrieved after maximum stimulation for IVF/ICSI.In addition eligible will be women with at least 1 previous treatment cycle with = 3 oocytes retrieved and (antral follicle count <7 or antimullerian hormone levels <1.1ng/ml)
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 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Uterine abnormalities;
Recent history of any current untreated endocrine abnormality;
Unilateral or bilateral hydrosalpinx (visible on USS, unless clipped);
Contraindications for the use of gonadotropins;
Recent history of severe disease requiring regular treatment

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare pregnancy rates after treament with corifollitropin alfa followed by highly purified HMG versus recombinant FSH in a GnRH antagonist protocol, for the treatment of young poor ovarian responders undergoing ovarian stimulation for ICSI ;Secondary Objective: To evaluate the level of ovarian response among investigational and control group ;Primary end point(s): Ongoing pregnancy rate defined as the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9-10 weeks of gestation ;Timepoint(s) of evaluation of this end point: 9-10 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): a. Clinical pregnancy rate defined as the presence of intrauterine<br>gestational sac at 7 weeks of gestation<br>b. Biochemical pregnancy defined as positive pregnancy test 2 weeks<br>after embryo transfer<br>c. Number of oocytes retrieved after oocytes retrieval before ICSI;Timepoint(s) of evaluation of this end point: a. 7 weeks of gestation<br>b. 2 weeks after embryo transfer<br>c. Day of oocyte retrieval