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

This study has been completed.
Sponsor:
Information provided by:
IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier:
NCT00378001
First received: September 15, 2006
Last updated: May 29, 2007
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: FSH-IBSA
Drug: GONAL-F
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Investigator Blinded, Randomized, Concurrent Control Study of Efficacy and Tolerability of Two FSH Preparations (Fostimon® Versus Gonal-F®) in Women Undergoing IVF

Resource links provided by NLM:


Further study details as provided by IBSA Institut Biochimique SA:

Primary Outcome Measures:
  • The primary endpoint is the total number of oocytes retrieved.

Secondary Outcome Measures:
  • Total FSH dose (IUs);number of days of FSH stimulation and stimulation duration;number of follicles >14 mm on the day of hCG injection;
  • 17-β estradiol (E2) serum concentration on the day of hCG injection;cancellation rate with reasons;
  • Fertilization rate: number of 2PN (or already cleaved) embryos;
  • Total number of embryos,number transferred, frozen and discarded;implantation rate;number of transferred embryos; clinical pregnancy rate, per stimulated cycle, per oocyte retrieval and per embryo transfer.

Estimated Enrollment: 152
Study Start Date: March 2005
Estimated Study Completion Date: May 2005
Detailed Description:

This is a prospective, multicenter, investigator blinded, randomized, concurrent control, phase III clinical trial. Patients meeting the eligibility requirements of the study will be randomly assigned to receive either the test drug (Fostimon®, IBSA) or the reference drug (Gonal-F®, Serono Inc.). Investigators will be blinded by not allowing them to have any contact with the study medications (supplied in boxes labeled in a manner that does not reveal the content of the boxes), and requesting that patients do not make any statements to the investigator that might indicate the treatment to which they were assigned. Equivalence testing with regard to the primary outcome variable will establish whether the two treatments are indeed similarly effective.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378001

Locations
United States, California
Fertility Physicians of Northern California
Palo Alto, California, United States, 94301
San Diego Fertility Center
San Diego, California, United States, 92130
UCSF In Vitro Fertilization
San Francisco, California, United States, 94115-0916
United States, Washington
Seattle Reproductive Medicine
Seattle, Washington, United States, 98109
Sponsors and Collaborators
IBSA Institut Biochimique SA
Investigators
Principal Investigator: Valerie Baker, MD Fertility Physicians of Northern California
Principal Investigator: Victor Y Fujimoto, MD UCSF In Vitro Fertilization
Principal Investigator: L. Michael Kettel, MD San Diego Fertility Center
Principal Investigator: Michael R Soules, MD Seattle Reproductive Medicine
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00378001     History of Changes
Other Study ID Numbers: 03CHUS/FSH03
Study First Received: September 15, 2006
Last Updated: May 29, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by IBSA Institut Biochimique SA:
Infertility, FSH, IVF, Ovarian stimulation

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Follicle Stimulating Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014