Randomised Clinical Trial Comparing Highly Purified FSH Formulation (Fostimon®) and Recombinant FSH (Gonal-F®) in GnRH-antagonist Controlled Ovarian Hyperstimulation Cycles.

IBSA Institut Biochimique SA16 sites in 6 countries710 target enrollmentJanuary 2014

ConditionsInfertility

InterventionsUrofollitrophin Follitrophin alpha

DrugsUrofollitrophin Follitrophin alpha

Overview

Phase: Phase 4
Intervention: Urofollitrophin
Conditions: Infertility
Sponsor: IBSA Institut Biochimique SA
Enrollment: 710
Locations: 16
Primary Endpoint: Clinical Pregnancy Rate
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled ovarian hyperstimulation in a GnRH-antagonist cycle.

Registry

clinicaltrials.gov

Start Date

January 2014

End Date

August 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

IBSA Institut Biochimique SA

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age: 18-38 years old;
•BMI: 18-28 kg/m2;
•Less than 3 previously completed IVF cycles;
•Basal FSH \<10 IU/L and E2 \<80 pg/ml;
•TSH \< 2.5 mIU/L
•\>10 and \<30 antral follicles 2-10 mm in size for both ovaries combined
•AMH: \>1 ng/ml (7.15 pmol/l) and \<5.6 ng/ml (40.0 pmol/l)
•Presence and adequate visualization of both ovaries;
•Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination;

Exclusion Criteria

•Primary ovarian failure or women known as poor responders;
•PCO and PCOS;
•Severe OHSS in a previous COH cycle;
•Uterine malformation that may impair the possibility to get pregnant;
•Ovarian cysts \>10 mm;
•Hydrosalpinx that have not been surgically removed or ligated;
•Endometriosis stage 3 or 4;
•Oocyte donation;
•Severe male factor;
•Pathologies associated with any contraindication of being pregnant;

Arms & Interventions

Fostimon®

75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA)

Intervention: Urofollitrophin

Gonal-F®

75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono)

Intervention: Follitrophin alpha

Outcomes

Primary Outcomes

Clinical Pregnancy Rate

Time Frame: 8 weeks

A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation;

Secondary Outcomes

Delivery Rate(9 months)
Cumulative Pregnancy Rate(2 years)
Embryo Quality (Number of Top Quality Embryos Transferred Per Patient)(On culture day 3)
Positive Serum Pregnancy Test Rate(2 weeks after embryo transfer)
Number of Follicles >16 mm on the Day of hCG Injection(10-15 days after starting FSH stimulation)
Total Number of Oocytes Retrieved(end of treatment period, approximately 2 - 3 weeks.)
Fertilization Rate(end of treatment period, approximately 2 - 3 weeks)