Overview

This trial is active, not recruiting.

Condition infertility
Treatments urofollitrophin, follitrophin alpha
Phase phase 4
Sponsor IBSA Institut Biochimique SA
Start date January 2014
End date June 2016
Trial size 712 participants
Trial identifier NCT01969201, 13EU/FSH01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA)
urofollitrophin human derived follicle stimulation hormone
(Active Comparator)
75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono)
follitrophin alpha Recombinant follicle stimulation hormone

Primary Outcomes

Measure
Clinical pregnancy rate
time frame: 8 weeks

Secondary Outcomes

Measure
Number of follicles >16 mm on the day of hCG injection
time frame: 10-15 days after starting FSH stimulation
Total number of oocytes retrieved
time frame: 2-3 weeks
Fertilization rate
time frame: 2-3 weeks
Embryo quality
time frame: On culture day 3
Positive serum pregnancy test
time frame: 2 weeks after embryo transfer
Delivery rate
time frame: 9 months
Cumulative pregnancy rate
time frame: 2 years

Eligibility Criteria

Female participants from 18 years up to 38 years old.

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; - History of recurrent miscarriage (more than 3 previous miscarriages); - Hypersensitivity to the study medication; - Abnormal bleeding of undetermined origin; - Uncontrolled thyroid or adrenal dysfunction; - Neoplasias; - Severe impairment of renal and/or hepatic function.

Additional Information

Official title Randomised Clinical Trial Comparing Highly Purified FSH Formulation (Fostimon®) and Recombinant FSH (Gonal-F®) in GnRH-antagonist Controlled Ovarian Hyperstimulation Cycles.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by IBSA Institut Biochimique SA.