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Completed

NCT Number: NCT00971152

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ovo Fertilité

Montreal, Quebec, H4P 2S4, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

menotropins for injection

Drug

comparison of different dosages

Other names: Menopur

urofollitropin for injection

Drug

comparison of different dosages

Other names: Bravelle

Primary outcomes

  1. Number of metaphase II oocytes retrieved during the course of one treatment cycle

    Time frame: 2 years

Secondary outcomes

  1. Number of follicles recruited per patient during stimulation

    Time frame: 2 years

  2. Fertilization rate per patient (number of normally fertilized (with 2 pronuclei) oocytes/number of mature oocytes collected)

    Time frame: 2 years

  3. Embryo cleavage rate per patient (number of divided normally fertilized oocytes/number of normally fertilized oocytes)

    Time frame: 2 years

  4. Number of embryos available per patient

    Time frame: 2 years

  5. Number of supernumerary embryos available for cryopreservation per patient

    Time frame: 2 years

  6. Implantation rate

    Time frame: 2 years

  7. Biochemical pregnancy rate

    Time frame: 2 years

  8. Clinical pregnancy rate

    Time frame: 2 years

  9. Rate of multiple gestation

    Time frame: 2 years

  10. Ongoing pregnancy rate

    Time frame: 2 years

  11. Live birth rate

    Time frame: 2 years

  12. rate of occurrence of ovarian hyperstimulation syndrome (OHSS)

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Clinique Ovo

Industry

Collaborators

  • Ferring Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2014
First posted
Sep 3, 2009
Registry last updated
Mar 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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