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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
IBSA Institut Biochimique SA Identifier:
First received: October 8, 2013
Last updated: March 6, 2017
Last verified: March 2017
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 Intervention Phase
Drug: Urofollitrophin
Drug: Follitrophin alpha
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:

Further study details as provided by IBSA Institut Biochimique SA:

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

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

  • Delivery rate [ Time Frame: 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.

Enrollment: 712
Actual Study Start Date: January 2014
Estimated Study Completion Date: March 2018
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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.
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: IBSA Institut Biochimique SA Identifier: NCT01969201     History of Changes
Other Study ID Numbers: 13EU/FSH01
Study First Received: October 8, 2013
Last Updated: March 6, 2017
Individual Participant Data  
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 processed this record on April 21, 2017