A phase III, randomized, double-blind, active-controlled, non-inferiority clinical trial to investigate the efficacy and safety of a single injection of Org 36286 (corifollitropin alfa) to induce multifollicular development for controlled ovarian stimulation using daily recombinant FSH as a reference

Phase 3

Completed

• Conditions: Infertiliteit; Infertility; 10014701

• Registration Number: NL-OMON29984
• Lead Sponsor: Organon Nederland bv

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

38819:
-Females of couples with an indication for COS and IVF or ICSI;
- >18 and <36 years of age at the time of signing informed consent;
-Body weight > 60 and < 90 kg and BMI > 18 and < 32 kg/m2;
-Normal menstrual cycle length: 24-35 days;
-Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is allowed)
38821:
-Subjects who received at least one dose of either Org 36286 or Puregon/Follistim in trial 38819
-Ongoing pregnancy confirmed by ultrasound at least 10 weeks after embryo transfer in trial 38819
38831:
-Subjects from whom embryos have been cryopreserved in trial 38819 of which at least one embryo is thawed for use in a subsequent FTET cycle.

Exclusion Criteria

38819:
-More than 20 basal antral follicles <11 mm (both ovaries combined) as measured on USS in the early follicular phase (menstrual cycle day 2-5);
-Less than 2 ovaries or any other ovarian abnormality (including endometrioma > 10 mm; visible on USS);
-Presence of unilateral or bilateral hydrosalphinx (visible on USS);
-Presence of any clinically relevant pathology affecting the uterine cavity or fibroids
>5 cm;
-More than three unsuccessful IVF cycles since the last established ongoing pregnancy (if applicable);
-History of non- or low ovarian response to FSH/hMG treatment;
-History of recurrent miscarriage (3 or more, even when unexplained);
-FSH > 12 IU/L or LH > 12 IU/L as measured by the local laboratory (sample taken during the early follicular phase: menstrual cycle day 2-5);
-Previous use of Org 36286;
-Use of hormonal preparations within 1 month prior to randomization;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>38819:<br /><br>pregnancy<br /><br><br /><br>Note:<br /><br>38821 (evaluation): pregnancy, mode of delivery, neonatal outcome.<br /><br><br /><br>38831 (evaluation): number and quality of the embryos transferred after thawing<br /><br>and the outcome of the FTET cycle.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>38819:<br /><br>number of oocytes retrieved<br /><br>safety: ((S)AEs, occurence of moderate/severe OHSS and antibody formation)</p><br>