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

Study Overview
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Brief Summary
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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.

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

Conditions
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Subfertility

Intervention / Treatment
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* Drug: menotropins for injection
* Drug: urofollitropin for injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 450 IU daily dose of gonadotrophin<br> | Drug: menotropins for injection<br>* comparison of different dosages<br>* Other names: Menopur;Drug: urofollitropin for injection<br>* comparison of different dosages<br>* Other names: Bravelle;|
| Experimental: 600 IU daily dose of gonadotrophin<br> | Drug: menotropins for injection<br>* comparison of different dosages<br>* Other names: Menopur;Drug: urofollitropin for injection<br>* comparison of different dosages<br>* Other names: Bravelle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of metaphase II oocytes retrieved during the course of one treatment cycle |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 embryos available per patient |  | 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 | 
| Ongoing pregnancy rate |  | 2 years | 
| Live birth rate |  | 2 years | 
| rate of occurrence of ovarian hyperstimulation syndrome (OHSS) |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, dose comparison of gonadotrophins, poor responder to ovarian stimulation