Effect of recombinant FSH dosing following corifollitropin alfa in patients undergoing IVF/ICSI in a GnRH antagonist protocol: a randomized controlled dose-finding study.

Phase 1

• Conditions: Subfertility in need of IVF and IVF-ICSI treatment; MedDRA version: 20.0 Level: LLT Classification code 10042392 Term: Subfertility (female) System Organ Class: 100000004872; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2018-002000-13-BE
• Lead Sponsor: niversity hospital Brussel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-09
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 261

Inclusion Criteria

•Female age: > 18 to < 38 years
• The patient must have undergone not more than three consecutive unsuccessful IVF/ICSI cycles since the last ongoing pregnancy (whether fresh and/or several frozen ET resulted from these attempts)
•BMI =29 Kg /m2
•Patients of = 36 years old, body weight should be = 60kg
•Patients of >36 years old, body weight should be > 50 kg
•Regular normo-ovulatory menstrual cycles (26–35 days)
•Basal FSH <10 IU/l, basal E2 <60 pg/ml and basal Progesteone (< 1.5 ng/mL) (normal cycle day-3 basal serum hormone levels), to be measured on cycle day 2 or 3 of the treatment cycle
•Normal ultrasound scan (presence of both ovaries without evidence of abnormality within 6 months)
•AFC >7 and < 20
•No pill within the 3 months before treatment
•Signed informed consent

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 261
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Polycystic ovarian syndrome (PCOS) according to the Rotterdam classification (2004)
•Oocyte donors
•Poor responder patients (development of <4 follicles in previous IVF/ICSI or cancelled cycles)
•Endometriosis = grade 3
•Contraindications to the use of gonadotropins
•Abnormal vaginal bleeding of unknown cause
•History of ovarian hyperstimulation syndrome (OHSS) or a previous ovarian stimulation cycle with more than 30 follicles of 11 mm or higher (as recommended by the Elonva® Summary of Product Characteris-tics)
•A history of recurrent miscarriage (three or more consecutive miscarriages)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Compare the mean serum progesterone level (ng/mL) on day of hCG between the study groups.;Secondary Objective: Assess the number of retrieved oocytes, number of mature oocytes, number of top quality embryos on Day 3, clinical pregnancy rate (number of viable pregnancies at 6 weeks of gestation per ITT and PP), ongo-ing pregnancy rate (number of viable pregnancies at 12 weeks of gestation per ITT and PP), miscarriage rate and percentage of patients with a P value above 1.5 ng/mL on the day of hCG.;Primary end point(s): -Mean serum P level on trigger day;Timepoint(s) of evaluation of this end point: at the end of inclusion

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): -Number of COCs retrieved<br> -Number of patients who underwent FA<br> -Clinical pregnancy rate<br> -Ongoing pregnancy rate<br> -Miscarriage rate<br> ;Timepoint(s) of evaluation of this end point: at the end of inclusion