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

Subfertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00971152
• Other study ID #: F-GYN-08-02
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2009
• Last updated: March 12, 2014
• Start date: September 2009
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: OVO R & D
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: February 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Subfertility

Intervention

Drug:
• menotropins for injection
comparison of different dosages
• urofollitropin for injection
comparison of different dosages

Locations

Country	Name	City	State
Canada	Ovo Fertilité	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
OVO R & D	Ferring Pharmaceuticals

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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.

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of metaphase II oocytes retrieved during the course of one treatment cycle		2 years	No
Secondary	Number of follicles recruited per patient during stimulation		2 years	No
Secondary	Fertilization rate per patient (number of normally fertilized (with 2 pronuclei) oocytes/number of mature oocytes collected)		2 years	No
Secondary	Embryo cleavage rate per patient (number of divided normally fertilized oocytes/number of normally fertilized oocytes)		2 years	No
Secondary	Number of embryos available per patient		2 years	No
Secondary	Number of supernumerary embryos available for cryopreservation per patient		2 years	No
Secondary	Implantation rate		2 years	No
Secondary	Biochemical pregnancy rate		2 years	No
Secondary	Clinical pregnancy rate		2 years	No
Secondary	Rate of multiple gestation		2 years	Yes
Secondary	Ongoing pregnancy rate		2 years	No
Secondary	Live birth rate		2 years	No
Secondary	rate of occurrence of ovarian hyperstimulation syndrome (OHSS)		2 years	Yes

External Links

•   OVO fertilité website