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

O

Ovo Clinic

Status and phase

Completed
Phase 3

Conditions

Subfertility

Treatments

Drug: menotropins for injection
Drug: urofollitropin for injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT00971152
F-GYN-08-02

Details and patient eligibility

About

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.

Enrollment

366 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

366 participants in 2 patient groups

450 IU daily dose of gonadotrophin
Active Comparator group
Treatment:
Drug: urofollitropin for injection
Drug: menotropins for injection
600 IU daily dose of gonadotrophin
Experimental group
Treatment:
Drug: urofollitropin for injection
Drug: menotropins for injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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