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

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IBSA Institut Biochimique SA
• Treatments: Follicle Stimulating Hormone; Hormones

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;

• 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.