A Phase 2, Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian (Study 38826)(P06055)(COMPLETED)
Phase 2
Completed
- Conditions
- Fertilization
- Interventions
- Registration Number
- NCT00598208
- Lead Sponsor
- Organon and Co
- Brief Summary
The primary objective of this trial is to investigate the dose -response relationship of a single injection of Org 38286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 325
Inclusion Criteria
- Females of couples with an indication for COH and IVF or ICSI;
- >=18 and <=39 years of age at the time of signing informed consent;
- BMI >=18 and <=29 kg/m^2;
- Normal menstrual cycle length: 24-35 days;
- Ejaculatory sperm (use of donated and/or frozen sperm is allowed);
- Willing and able to sign informed consent.
Exclusion Criteria
- History of/or any current (treated) endocrine abnormality;
- History of ovarian hyperstimulation syndrome (OHSS);
- History of/or current polycystic ovary syndrome (PCOS) or current polycystic ovaries according to USS (at least 10 follicles of 2-8 mm in each ovary);
- More than three unsuccessful COH cycles since the last established ongoing pregnancy (if applicable);
- History of non- or low ovarian response to FSH/hMG treatment;
- Any clinically relevant hormone value outside the reference range during the early follicular phase (menstrual cycle day 2-7) as measured by the local laboratory (FSH, LH, E2, P, total T, TSH and prolactin):
- Any clinically relevant abnormal laboratory value;
- Less than 2 ovaries;
- Any ovarian and/or abdominal abnormality interfering with ultrasound examination;
- Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
- Epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease;
- History of 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 Org 32489 (Puregon®) and/or Org 37462 (Orgalutran®) and/or Pregnyl® or any of their components;
- Administration of investigational drugs within three months prior to signing informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 corifollitropin alfa 120 µg Org 36286 (corifollitropin alfa) 1 corifollitropin alfa 60 µg Org 36286 (corifollitropin alfa) 3 corifollitropin alfa 180 µg Org 36286 (corifollitropin alfa) 4 Follitropin beta injection Follitropin beta injection
- Primary Outcome Measures
Name Time Method Number of cumulus-oocyte-complexes retrieved 1 cycle
- Secondary Outcome Measures
Name Time Method Treatment failure rate 1 cycle