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
Intervention model parallel assignment
Primary purpose treatment
Masking investigator
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 March 2017.
Information provided to ClinicalTrials.gov by IBSA Institut Biochimique SA.