Investigate Dose of Org 36286 to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or IVF/ICSI (P07015)

Launched by ORGANON AND CO · Jun 19, 2008

Keywords

ClinConnect Summary

This trial was made up of two stages with different designs and was conducted at two clinical trial sites. Stage I was open-label and uncontrolled in a small cohort of women (n=6) to obtain first experience in employing Org 36286 in women meeting all inclusion and none of the exclusion criteria. Based on the results of a previous study, the most appropriate dose was anticipated to be 120 μg Org 36286, which was administered on Cycle Day 2 or 3. After seven days, treatment was continued with a fixed dose of 150 IU Puregon® SC. If the size of the leading follicle was \>=14 mm, 0.25 mg Orgalut...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Females of couples with an indication for COH and IVF or IVF/ICSI;
• • Body mass index (BMI) \>=18 and \<=29 kg/m\^2;
• • Normal menstrual cycle length: 24-35 days;
• • Ejaculatory sperm;
• Exclusion Criteria:
• • History of/or current endocrine abnormality such as polycystic ovary syndrome (PCOS), or polycystic ovaries according to ultrasound scan (USS), (treated) hyperprolactinemia or evidence of ovarian dysfunction;
• • More than three unsuccessful COH cycles for IVF since the last established ongoing pregnancy (if applicable);
• • History of non- or low ovarian response to FSH/human menopausal gonadotropin (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, luteinizing hormone \[LH\], estradiol \[E2\], progesterone \[P\], total testosterone \[T\], thyroid stimulating hormone \[TSH\], and prolactin);
• • Any clinically relevant abnormal laboratory value;
• • 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 or presence of alcohol or drug abuse within 12 months prior to signing informed consent;
• • Hypersensitivity to Orgalutran® or any of its components;
• • Administration of investigational drugs within three months prior to screening.
• • Use of hormonal preparations within one month prior to the start of Org 36286 with the exception of thyroid medication.