Status:
COMPLETED
A Study to Investigate the Efficacy and Safety of a Single Injection of Corifollitropin Alfa (Organon 36286) for Ovarian Stimulation Using Daily Recombinant Follicle Stimulating Hormone (FSH) as Reference (P05787)
Lead Sponsor:
Organon and Co
Conditions:
In Vitro Fertilization
Eligibility:
FEMALE
18-36 years
Phase:
PHASE3
Brief Summary
To investigate the efficacy and safety of a single injection of 150 μg Corifollitropin Alfa (Organon 36286) to induce multifollicular development for controlled ovarian stimulation using daily recombi...
Detailed Description
This is a randomized, double-blind, active-controlled, non-inferiority clinical trial investigating the efficacy and safety of a new treatment regimen with Corifollitropin Alfa, a recombinant gonadotr...
Eligibility Criteria
Inclusion
- Females of couples with an indication for Controlled Ovarian Stimulation (COS) and in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI);
- \>=18 and \<=36 years of age at the time of signing informed consent;
- Body weight \> 60 and \<=90 kg and body mass index (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
- 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 ultrasound scan (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/ human menopausal gonadotropin (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, human immunodeficiency virus (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.
Key Trial Info
Start Date :
June 27 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2008
Estimated Enrollment :
1509 Patients enrolled
Trial Details
Trial ID
NCT00696800
Start Date
June 27 2006
End Date
January 15 2008
Last Update
June 20 2024
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