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

This study has been completed.
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
OVO R & D
ClinicalTrials.gov Identifier:
NCT00971152
First received: September 2, 2009
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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
Subfertility
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00971152

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

Additional Information:
Publications:
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:
IVF
dose comparison of gonadotrophins
poor responder to ovarian stimulation

ClinicalTrials.gov processed this record on October 23, 2014