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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
710

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IBSA Institut Biochimique SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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