Status:
COMPLETED
Investigate Dose of Org 36286 to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or IVF/ICSI (P07015)
Lead Sponsor:
Organon and Co
Conditions:
Infertility
In Vitro Fertilization
Eligibility:
FEMALE
18-39 years
Phase:
PHASE2
Brief Summary
The primary objective of this trial was to investigate the appropriate dose of a single injection of Org 36286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyper...
Detailed Description
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 expe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2002
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00702806
Start Date
July 1 2001
End Date
October 15 2002
Last Update
August 15 2024
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