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

February 12, 2015 updated by: IBSA Institut Biochimique SA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

152

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94301
        • Fertility Physicians of Northern California
      • San Diego, California, United States, 92130
        • San Diego Fertility Center
      • San Francisco, California, United States, 94115-0916
        • UCSF In Vitro Fertilization
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Reproductive Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary endpoint is the total number of oocytes retrieved.

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (ACTUAL)

May 1, 2006

Study Completion (ACTUAL)

May 1, 2006

Study Registration Dates

First Submitted

September 15, 2006

First Submitted That Met QC Criteria

September 15, 2006

First Posted (ESTIMATE)

September 19, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 16, 2015

Last Update Submitted That Met QC Criteria

February 12, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03CHUS/FSH03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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