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

Phase 3

Completed

• Conditions: Subfertility
• Interventions: Drug: menotropins for injection; Drug: urofollitropin for injection

• Registration Number: NCT00971152
• Lead Sponsor: Clinique Ovo

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2009-09-02
• Study First Posted: 2009-09-03
• Primary Completion: 2013-10
• Study Completion: 2014-02
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-12
• Last Update Posted: 2014-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 366

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
450 IU daily dose of gonadotrophin	menotropins for injection	-
450 IU daily dose of gonadotrophin	urofollitropin for injection	-
600 IU daily dose of gonadotrophin	menotropins for injection	-
600 IU daily dose of gonadotrophin	urofollitropin for injection	-

Primary Outcome Measures

Name	Time	Method
Number of metaphase II oocytes retrieved during the course of one treatment cycle	2 years

Secondary Outcome Measures

Name	Time	Method
Number of follicles recruited per patient during stimulation	2 years
Fertilization rate per patient (number of normally fertilized (with 2 pronuclei) oocytes/number of mature oocytes collected)	2 years
Embryo cleavage rate per patient (number of divided normally fertilized oocytes/number of normally fertilized oocytes)	2 years
Number of supernumerary embryos available for cryopreservation per patient	2 years
Implantation rate	2 years
Biochemical pregnancy rate	2 years
Clinical pregnancy rate	2 years
Rate of multiple gestation	2 years
Number of embryos available per patient	2 years
rate of occurrence of ovarian hyperstimulation syndrome (OHSS)	2 years
Ongoing pregnancy rate	2 years
Live birth rate	2 years

Trial Locations

Locations (1)

Ovo Fertilité; 🇨🇦 Montreal, Quebec, Canada