Status:
COMPLETED
Predictive Factors for Ovarian Stimulation Using a Fixed Daily Dose of 200 IU Recombinant FSH (Study 142003)(P05696)
Lead Sponsor:
Organon and Co
Conditions:
Infertility
Eligibility:
FEMALE
18-39 years
Phase:
PHASE4
Brief Summary
The success of assisted reproductive technologies (ART) is critically dependent on optimizing protocols for controlled ovarian stimulation to provide adequate numbers of good quality oocytes and embry...
Eligibility Criteria
Inclusion
- Females of couples with an indication for In Vitro Fertilization (IVF) and/or Intracytoplasmic Sperm Injection (ICSI) scheduled for their first COS treatment cycle
- Females \>18 and \<=39 years of age at the time of signing informed consent
- Body Mass Index (BMI) \<= 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 endocrine abnormality
- Less than 2 ovaries or any other ovarian abnormality (inc.\>10mm endometrioma)
- Presence of unilateral or bilateral hydrosalpinx
- Presence of any clinically relevant pathology affecting the uterine cavity or fibroids \>= 5cm
- History of recurrent miscarriage (3 or more, even when unexplained)
- FSH or LH \> 12 IU/L as measured by a local laboratory (sample taken during the early follicular phase: menstrual day 2-5)
- Any clinically relevant abnormal laboratory value (FSH, LH, estradiol (E2), Progesterone (P), total Testosterone (T), prolactin, Thyroid Stimulating Hormone (TSH), blood biochemistry, hematology and urinalysis) based on a sample during the screening phase.
- Contraindications for the use of gonadotropins (tumors, pregnancy, lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts)
- Contraindications for the use of oral contraceptive pills (history of (h/o) thromboembolism, breast cancer, undiagnosed vaginal bleeding)
- Recent history of/or current epilepsy, Human Immunodeficiency Virus (HIV) infection, diabetes, cardiovascular, gastrointestinal, hepatic, renal or pulmonary disease
- Abnormal karyotyping of the patient or her partner (if karyotyping is performed)
- History or presence of alcohol or drug abuse within 12 months of signing the consent
- Use of hormonal preparations within one 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 the informed consent
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2008
Estimated Enrollment :
442 Patients enrolled
Trial Details
Trial ID
NCT00778999
Start Date
October 1 2006
End Date
July 24 2008
Last Update
February 4 2022
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