FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)

IBSA

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Drug: Follitrophin alpha; Drug: Urofollitrophin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01969201

13EU/FSH01

Details and patient eligibility

About

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.

Enrollment: 710 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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710 participants in 2 patient groups

Fostimon®

Experimental group

Description:

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

Treatment:

Drug: Urofollitrophin

Gonal-F®

Active Comparator group

Description:

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

Treatment:

Drug: Follitrophin alpha