To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(Study 107012)(COMPLETED)(P05690)

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00702845
• Date of registration: 18/06/2008
• Primary sponsor: Schering-Plough
• Public title: To Investigate Efficacy and Safety of a Single Injection of Org 36286 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (Ensure)(Study 107012)(COMPLETED)(P05690) Ensure
• Scientific title: A Phase III, Equivalence Clinical Trial to Investigate the Efficacy and Safety of a Single Injection of 100 µg Org 36286 (Corifollitropin Alfa) to Induce Multifollicular Development for Ovarian Stimulation Using Daily Recombinant FSH as Reference
• Date of first enrolment: January 2007
• Target sample size: 397
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00702845
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 kg and BMI >= 18 and <= 32 kg/m^2;

- Normal menstrual cycle length: 24-35 days;

- Availability of ejaculatory sperm (use of donated and/or cryopreserved sperm is
allowed);

- Willing and able to sign informed consent.

Exclusion Criteria:

- History of/or any current (treated) endocrine abnormality;

- History of ovarian hyper-response or ovarian hyperstimulation syndrome (OHSS);

- History of/or current polycystic ovary syndrome (PCOS);

- 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);

- Any clinically relevant abnormal laboratory value based on a sample taken during the
screening phase;

- Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation,
undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);

- Recent history of/or current epilepsy, HIV infection, diabetes, cardiovascular,
gastro-intestinal, hepatic, renal or pulmonary disease;

- Abnormal karyotyping of the patient or her partner (if karyotyping is performed);

- Smoking more than 5 cigarettes per day;

- History or presence of alcohol or drug abuse within 12 months prior to signing
informed consent;

- Previous use of Org 36286;

- Use of hormonal preparations within 1 month prior to randomization;

- Hypersensitivity to any of the concomitant medication prescribed as part of the
treatment regimen in this protocol;

- Administration of investigational drugs within three months prior to signing informed
consent.



Age minimum: 18 Years
Age maximum: 36 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Infertility

Intervention(s)

Drug: 150 IU recFSH (follitropin beta)

Drug: Org 36286 (corifollitropin alfa)

Primary Outcome(s)

The primary endpoint for the trial is number of oocytes retrieved. [Time Frame: One Controlled Ovarian Stimulation (COS) cycle]

Secondary Outcome(s)

Amount of recombinant FSH needed (total and from Day 8 to Day of hCG); Endocrinological parameters (FSH, LH, E2, P, inhibin-B); Number and size distribution of follicles as documented by ultrasonography during treatment and on the Day of hCG; [Time Frame: One Controlled Ovarian Stimulation (COS) cycle]

Number and quality of oocytes; Fertilization rate; Number and quality of embryos; Implantation rate; Miscarriage rate; Pregnancy rate [Time Frame: One Controlled Ovarian Stimulation (COS) cycle]

Secondary ID(s)

107012

EudraCT #: 2006-003811-36;

P05690

Source(s) of Monetary Support

Please refer to primary and secondary sponsors