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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Urofollitrophin
Follitrophin alpha
Sponsored by
IBSA Institut Biochimique SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring In vitro fertilization (IVF), Assisted reproduction technologies (ART), GnRH-antagonist, Follicle stimulating hormone (FSH)

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UCL- Cliniques Universitaires Saint Luc
  • Universitair Ziekenhuis Brussel
  • Spedali Civili di Brescia
  • Fondazione Ca'Granda, Osp Maggiore Policlinico
  • IRCCS San Raffaele
  • Università degli Studi di Napoli 'Federico II'
  • Azienda Ospedaliera Di Reggio Emilia
  • Clinica IVI Alicante
  • Institut Universitari Dexeus
  • Ginefiv Clínica de Fertilidad
  • Instituto Valenciano de Infertilidad (IVI)
  • Universitätsklinik für Frauenheilkunde
  • Universitäts-Frauenklinik
  • Prof. Bülent Urman
  • Ege University
  • Midland Fertility Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fostimon®

Gonal-F®

Arm Description

75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA)

75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono)

Outcomes

Primary Outcome Measures

Clinical Pregnancy Rate
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
Total Number of Oocytes Retrieved
Fertilization Rate
Embryo Quality (Number of Top Quality Embryos Transferred Per Patient)
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.
Positive Serum Pregnancy Test Rate
Two weeks after embryo transfer, a serum pregnancy test will be performed.
Delivery Rate
Cumulative Pregnancy Rate
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.

Full Information

First Posted
October 8, 2013
Last Updated
September 19, 2019
Sponsor
IBSA Institut Biochimique SA
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1. Study Identification

Unique Protocol Identification Number
NCT01969201
Brief Title
FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)
Acronym
FAST
Official Title
Randomised Clinical Trial Comparing Highly Purified FSH Formulation (Fostimon®) and Recombinant FSH (Gonal-F®) in GnRH-antagonist Controlled Ovarian Hyperstimulation Cycles.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IBSA Institut Biochimique SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
In vitro fertilization (IVF), Assisted reproduction technologies (ART), GnRH-antagonist, Follicle stimulating hormone (FSH)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
710 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fostimon®
Arm Type
Experimental
Arm Description
75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA)
Arm Title
Gonal-F®
Arm Type
Active Comparator
Arm Description
75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono)
Intervention Type
Drug
Intervention Name(s)
Urofollitrophin
Other Intervention Name(s)
human derived follicle stimulation hormone
Intervention Type
Drug
Intervention Name(s)
Follitrophin alpha
Other Intervention Name(s)
Recombinant follicle stimulation hormone
Primary Outcome Measure Information:
Title
Clinical Pregnancy Rate
Description
A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation;
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of Follicles >16 mm on the Day of hCG Injection
Time Frame
10-15 days after starting FSH stimulation
Title
Total Number of Oocytes Retrieved
Time Frame
end of treatment period, approximately 2 - 3 weeks.
Title
Fertilization Rate
Time Frame
end of treatment period, approximately 2 - 3 weeks
Title
Embryo Quality (Number of Top Quality Embryos Transferred Per Patient)
Description
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.
Time Frame
On culture day 3
Title
Positive Serum Pregnancy Test Rate
Description
Two weeks after embryo transfer, a serum pregnancy test will be performed.
Time Frame
2 weeks after embryo transfer
Title
Delivery Rate
Time Frame
9 months
Title
Cumulative Pregnancy Rate
Description
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.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Barri, MD
Organizational Affiliation
Institut Universitari Dexeus, Barcelona, Spain
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Christophe Blockeel, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel, Belgium
Official's Role
Study Chair
Facility Information:
Facility Name
UCL- Cliniques Universitaires Saint Luc
City
Brussels
Country
Belgium
Facility Name
Universitair Ziekenhuis Brussel
City
Brussels
Country
Belgium
Facility Name
Spedali Civili di Brescia
City
Brescia
Country
Italy
Facility Name
Fondazione Ca'Granda, Osp Maggiore Policlinico
City
Milan
Country
Italy
Facility Name
IRCCS San Raffaele
City
Milan
Country
Italy
Facility Name
Università degli Studi di Napoli 'Federico II'
City
Naples
Country
Italy
Facility Name
Azienda Ospedaliera Di Reggio Emilia
City
Reggio Emilia
Country
Italy
Facility Name
Clinica IVI Alicante
City
Alicante
ZIP/Postal Code
03015
Country
Spain
Facility Name
Institut Universitari Dexeus
City
Barcelona
ZIP/Postal Code
8028
Country
Spain
Facility Name
Ginefiv Clínica de Fertilidad
City
Madrid
Country
Spain
Facility Name
Instituto Valenciano de Infertilidad (IVI)
City
Sevilla
ZIP/Postal Code
40011
Country
Spain
Facility Name
Universitätsklinik für Frauenheilkunde
City
Bern
State/Province
Be
Country
Switzerland
Facility Name
Universitäts-Frauenklinik
City
Basel
State/Province
BS
Country
Switzerland
Facility Name
Prof. Bülent Urman
City
Istanbul
Country
Turkey
Facility Name
Ege University
City
Izmir
Country
Turkey
Facility Name
Midland Fertility Services
City
Aldridge
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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

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