Effect of a Higher Than Maximum 450IU Gonadotropin Dose in an In-vitro Fertilization Cycle

Effect of a Higher Than Maximum 450IU Gonadotropin Dose on Patient Outcomes in an In-Vitro Fertilization Setting: a Randomized Controlled Non-infertility Trial

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 administered for women who are at risk of a poor ovarian response in order to determine if one dose or the other results in improved cycle outcomes.

Inclusion Criteria:

• 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 Criteria:

• 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