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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01969201
Recruitment Status : Completed
First Posted : October 25, 2013
Last Update Posted : March 27, 2018
Information provided by (Responsible Party):
IBSA Institut Biochimique SA

Brief 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.

Condition or disease Intervention/treatment Phase
Infertility Drug: Urofollitrophin Drug: Follitrophin alpha Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 712 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Randomised Clinical Trial Comparing Highly Purified FSH Formulation (Fostimon®) and Recombinant FSH (Gonal-F®) in GnRH-antagonist Controlled Ovarian Hyperstimulation Cycles.
Actual Study Start Date : January 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

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 Name: 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 Name: Recombinant follicle stimulation hormone

Primary Outcome Measures :
  1. 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;

Secondary Outcome Measures :
  1. Number of follicles >16 mm on the day of hCG injection [ Time Frame: 10-15 days after starting FSH stimulation ]
  2. Total number of oocytes retrieved [ Time Frame: 2-3 weeks ]
  3. Fertilization rate [ Time Frame: 2-3 weeks ]
  4. Embryo quality [ Time Frame: On culture day 3 ]
    Quality of the embryos will be evaluated just before embryo transfer on Day 3.

  5. Positive serum pregnancy test [ Time Frame: 2 weeks after embryo transfer ]
    Two weeks after embryo transfer, a serum pregnancy test will be performed.

  6. Delivery rate [ Time Frame: 9 months ]
  7. 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.

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01969201

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

Responsible Party: IBSA Institut Biochimique SA Identifier: NCT01969201     History of Changes
Other Study ID Numbers: 13EU/FSH01
First Posted: October 25, 2013    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by IBSA Institut Biochimique SA:
In vitro fertilization (IVF)
Assisted reproduction technologies (ART)
Follicle stimulating hormone (FSH)

Additional relevant MeSH terms:
Ovarian Hyperstimulation Syndrome
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs