Clinical Efficacy and Tolerability of Two FSH Preparations (Human FSH Versus rFSH - Follitropin Alpha) in Women Undergoing IVF

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous FSH preparations (Fostimon®, IBSA vs Gonal-F®, Serono Inc.) when administered to patients undergoing controlled ovarian stimulation for IVF.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• >/=18 and <40 years old;

• BMI between 18 and 30 kg/m2;

• less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery);

• basal FSH <10 IU/L and E2 <80 pg/mL;

• Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through a hysterosalpingogram, sonohysterogram, or hysteroscopic examination;

• >10 antral follicles 2-10 mm in size;

• Normal or clinically insignificant hematology and blood chemistry values. TSH levels must be within the normal limits for the testing laboratory, or the patient should be euthyroid as determined by the investigator (e.g. normal free thyroxine). TSH can be low secondary to exogenous thyroid medication where patient is euthyroid;

• Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule.

Exclusion Criteria:

• · age <18 and >/=40 years;

• primary ovarian failure or women known as poor responders (i.e. requiring more than 300 IU of FSH as a starting dose in previous treatment cycles or having less than 3 oocytes retrieved, or with an E2 serum concentration <1800 pmol/L/500pg/mL);

• prior ovarian hyperstimulation syndrome (OHSS), polycystic ovarian syndrome that would normally be started at a lower FSH dose than is initially required by the study (i.e. 300 IU), or likely intolerance to even two days of 300 IU FSH.

• one or both ovaries inaccessible for oocyte retrieval;

• ovarian cysts >20 mm;

• hydrosalpinx that have not been surgically removed or ligated;

• stage 3 or 4 endometriosis;

• oocyte donation;

• implantation of previously frozen embryos;

• patients affected by pathologies associated with any contraindication of being pregnant;

• hypersensitivity to the study medication;

• abnormal bleeding of undetermined origin;

• uncontrolled thyroid or adrenal dysfunction;

• neoplasias;

• severe impairment of renal and/or hepatic function;

• use of concomitant medications that might interfere with study evaluations (e.g. nonstudy hormonal medications, prostaglandin inhibitors, psychotropic agents).