Subfertility
Conditions
Keywords
IVF, dose comparison of gonadotrophins, poor responder to ovarian stimulation
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.
Interventions
DRUGmenotropins for injection
comparison of different dosages
DRUGurofollitropin for injection
comparison of different dosages
Sponsors
Ferring Pharmaceuticals
Clinique Ovo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of metaphase II oocytes retrieved during the course of one treatment cycle | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Number of follicles recruited per patient during stimulation | 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 |
| Biochemical pregnancy rate | 2 years |
Countries
Canada
Outcome results
None listed