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

• Status: Completed
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Clinique Ovo; OVO R & D
• Collaborator: Ferring Pharmaceuticals
• Treatments: Menotropins

Criteria

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