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

This study has been completed.
Ferring Pharmaceuticals
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: September 2, 2009
Last updated: March 12, 2014
Last verified: March 2014

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.

Condition Intervention Phase
Drug: menotropins for injection
Drug: urofollitropin for injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by OVO R & D:

Primary Outcome Measures:
  • Number of metaphase II oocytes retrieved during the course of one treatment cycle [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of follicles recruited per patient during stimulation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Fertilization rate per patient (number of normally fertilized (with 2 pronuclei) oocytes/number of mature oocytes collected) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Embryo cleavage rate per patient (number of divided normally fertilized oocytes/number of normally fertilized oocytes) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of embryos available per patient [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Number of supernumerary embryos available for cryopreservation per patient [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Implantation rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Biochemical pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Clinical pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Rate of multiple gestation [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Ongoing pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Live birth rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • rate of occurrence of ovarian hyperstimulation syndrome (OHSS) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 366
Study Start Date: September 2009
Study Completion Date: February 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 450 IU daily dose of gonadotrophin Drug: menotropins for injection
comparison of different dosages
Other Name: Menopur
Drug: urofollitropin for injection
comparison of different dosages
Other Name: Bravelle
Experimental: 600 IU daily dose of gonadotrophin Drug: menotropins for injection
comparison of different dosages
Other Name: Menopur
Drug: urofollitropin for injection
comparison of different dosages
Other Name: Bravelle


Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00971152

Canada, Quebec
Ovo Fertilité
Montreal, Quebec, Canada, H4P 2S4
Sponsors and Collaborators
Ferring Pharmaceuticals
Principal Investigator: Louise Lapensee, MD OVO Fertilité
Study Director: Jacques Kadoch, MD OVO Fertilité and OVO R & D
  More Information

Additional Information:
Srouji SS, Missmer SA, Ginsburg ES (2004) Impact of increasing gonadotropins > 450 IU on cycle outcome. Brigham and Women's Hospital, Boston, MA. Fertil Steril 82 (Suppl 2): P292.
Flisser E, Krey LC, Berkeley AS (2005) Diminishing Returns of Increasing Gonadotropin Dosage in Subsequent In Vitro Fertilization (IVF) Cycles?. Fertil Steril 84 (Suppl 1) P483.

Responsible Party: OVO R & D
ClinicalTrials.gov Identifier: NCT00971152     History of Changes
Other Study ID Numbers: F-GYN-08-02
Study First Received: September 2, 2009
Last Updated: March 12, 2014
Health Authority: Canada: Health Canada

Keywords provided by OVO R & D:
dose comparison of gonadotrophins
poor responder to ovarian stimulation

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014