Status:
COMPLETED
Effect of a Higher Than Maximum 450IU Gonadotropin Dose in an In-vitro Fertilization Cycle
Lead Sponsor:
Clinique Ovo
Collaborating Sponsors:
Ferring Pharmaceuticals
Conditions:
Subfertility
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief Summary
This goal of this study is to evaluate the outcomes from in vitro fertilization cycles where a 450 IU daily dose of gonadotropins is administered compared to those where a 600 IU daily dose is adminis...
Eligibility Criteria
Inclusion
- RESIDENT OF CANADA
- Premenopausal
- Age 40 years or less at the time of enrollment
- At risk of a poor ovarian response defined as: either \<5 oocytes or \<8 follicles in a previous cycle, FSH \> 10 IU/L, AMH \< 1 pg/ml , antral follicle count less or equal to 8 or previous IVF cancellation
- Primary infertility or secondary
- Not previously undertaken a cycle that was included in this study
Exclusion
- Simultaneous participation in another clinical trial
- Body mass index (BMI) \> 38 kg/m2
- Early follicular phase (day 2-4) serum FSH level \> 20 mIU/ml
- Any contraindication to being pregnant and carrying a pregnancy to term
- Contraindication for the use of Estrace® , Suprefact®, Menopur®, Bravelle®, hCG, and luteal phase support medication
- Any ovarian or abdominal abnormality that may interfere with adequate transvaginal ultrasound evaluation
- Administration of any investigational drugs within three months prior to study enrollment
- Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study
- Positive results of screening of either partner for HIV antibodies, Hepatitis B (other than for surface antibodies present after vaccination) or Hepatitis C
- Unwillingness to give written informed consent
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
366 Patients enrolled
Trial Details
Trial ID
NCT00971152
Start Date
September 1 2009
End Date
February 1 2014
Last Update
March 13 2014
Active Locations (1)
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1
Ovo Fertilité
Montreal, Quebec, Canada, H4P 2S4