Trial | NCT00971152  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    urofollitropin ...

  • Study Participants

    366
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.
Study Started
Sep 30
2009
Primary Completion
Oct 31
2013
Study Completion
Feb 28
2014
Last Update
Mar 13
2014
Estimate

Drug menotropins for injection

comparison of different dosages

  • Other names: Menopur

Drug urofollitropin for injection

comparison of different dosages

  • Other names: Bravelle

450 IU daily dose of gonadotrophin Active Comparator

600 IU daily dose of gonadotrophin Experimental

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
No Results Posted