A Phase 2, Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286… (NCT00598208) | Clinical Trial Compass
CompletedPhase 2
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)
325 participantsStarted 2003-05-19
Plain-language 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.
Who can participate
Age range18 Years – 39 Years
SexFEMALE
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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…