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

September 19, 2019 updated by: IBSA Institut Biochimique SA

Randomised Clinical Trial Comparing Highly Purified FSH Formulation (Fostimon®) and Recombinant FSH (Gonal-F®) in GnRH-antagonist Controlled Ovarian Hyperstimulation Cycles.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

710

Phase

  • Phase 4

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

  • Belgium
      • Brussels, Belgium
        • UCL- Cliniques Universitaires Saint Luc
      • Brussels, Belgium
        • Universitair Ziekenhuis Brussel
  • Italy
      • Brescia, Italy
        • Spedali Civili di Brescia
      • Milan, Italy
        • IRCCS San Raffaele
      • Milan, Italy
        • Fondazione Ca'Granda, Osp Maggiore Policlinico
      • Naples, Italy
        • Università degli Studi di Napoli 'Federico II'
      • Reggio Emilia, Italy
        • Azienda Ospedaliera di Reggio Emilia
  • Spain
      • Alicante, Spain, 03015
        • Clinica IVI Alicante
      • Barcelona, Spain, 8028
        • Institut Universitari Dexeus
      • Madrid, Spain
        • Ginefiv Clínica de Fertilidad
      • Sevilla, Spain, 40011
        • Instituto Valenciano de Infertilidad (IVI)
  • Switzerland
    • BS
      • Basel, BS, Switzerland
        • Universitäts-Frauenklinik
    • Be
      • Bern, Be, Switzerland
        • Universitätsklinik für Frauenheilkunde
  • Turkey
      • Istanbul, Turkey
        • Prof. Bülent Urman
      • Izmir, Turkey
        • Ege University
  • United Kingdom
      • Aldridge, United Kingdom
        • Midland Fertility Services

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 38 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Fostimon®
75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA)
Drug: Urofollitrophin
Other Names:
  • human derived follicle stimulation hormone
ACTIVE_COMPARATOR: Gonal-F®
75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono)
Drug: Follitrophin alpha
Other Names:
  • Recombinant follicle stimulation hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Pregnancy Rate
Time Frame: 8 weeks
A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation;
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Follicles >16 mm on the Day of hCG Injection
Time Frame: 10-15 days after starting FSH stimulation
10-15 days after starting FSH stimulation
Total Number of Oocytes Retrieved
Time Frame: end of treatment period, approximately 2 - 3 weeks.
end of treatment period, approximately 2 - 3 weeks.
Fertilization Rate
Time Frame: end of treatment period, approximately 2 - 3 weeks
end of treatment period, approximately 2 - 3 weeks
Embryo Quality (Number of Top Quality Embryos Transferred Per Patient)
Time Frame: On culture day 3
The embryo quality evaluation will be performed on culture day 3, just before embryo transfer and will consist in the assessment of blastomeres number and 2 embryo morphology parameters: degree of fragmentation and cell division aspect.
On culture day 3
Positive Serum Pregnancy Test Rate
Time Frame: 2 weeks after embryo transfer
Two weeks after embryo transfer, a serum pregnancy test will be performed.
2 weeks after embryo transfer
Delivery Rate
Time Frame: 9 months
9 months
Cumulative Pregnancy Rate
Time Frame: 2 years
Patients who will not get pregnant during the study, will be allowed to perform a frozen embryo transfer. Cumulative pregnancy rate will include also pregnancies achieved after a frozen embryo transfer.
2 years

Collaborators and Investigators

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

Sponsor

IBSA Institut Biochimique SA

Investigators

  • Study Chair: Pedro Barri, MD, Institut Universitari Dexeus, Barcelona, Spain
  • Study Chair: Christophe Blockeel, MD, Universitair Ziekenhuis Brussel, Belgium

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 (ACTUAL)

January 1, 2014

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

October 8, 2013

First Submitted That Met QC Criteria

October 24, 2013

First Posted (ESTIMATE)

October 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 9, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13EU/FSH01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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