InfertilityPhase 4FASTNCT01969201

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

A Phase 4 study testing Urofollitrophin and Follitrophin alpha in people with Infertility, run by IBSA Institut Biochimique SA at 16 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 38 years, women only
Conditions the study is for: Infertility
What is being tested?: Urofollitrophin and Follitrophin alpha
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 710 participants
Where: 16 sitesin 6 countries
Study dates: Jan 2014to Aug 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 38 years
Women only
No healthy volunteers
Adult

Who may be able to join

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

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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;

Who cannot join

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;

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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.

Trial locations and contacts

16 sites in 6 countries.

Country

City, postcode or hospital

16 sites in 6 countries

Italy5 sites

Spedali Civili di Brescia
Brescia
Fondazione Ca'Granda, Osp Maggiore Policlinico
Milan
IRCCS San Raffaele
Milan
Università degli Studi di Napoli 'Federico II'
Naples
Azienda Ospedaliera Di Reggio Emilia
Reggio Emilia

Other trials in Italy

Spain4 sites

Clinica IVI Alicante
Alicante, 03015
Institut Universitari Dexeus
Barcelona, 8028
Ginefiv Clínica de Fertilidad
Madrid
Instituto Valenciano de Infertilidad (IVI)
Seville, 40011

Other trials in Spain

Belgium2 sites

UCL- Cliniques Universitaires Saint Luc
Brussels
Universitair Ziekenhuis Brussel
Brussels

Other trials in Belgium

Switzerland2 sites

Universitäts-Frauenklinik
Basel, Canton of Basel-City
Universitätsklinik für Frauenheilkunde
Bern, Canton of Bern

Other trials in Switzerland

Turkey (Türkiye)2 sites

Prof. Bülent Urman
Istanbul
Ege University
Izmir

Other trials in Turkey (Türkiye)

United Kingdom1 site

Midland Fertility Services
Aldridge

Other trials in United Kingdom

About this study

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

Conditions: Infertility
Being tested: Urofollitrophin, Follitrophin alpha
Keywords: In vitro fertilization (IVF), Assisted reproduction technologies (ART), GnRH-antagonist, Follicle stimulating hormone (FSH)
Medical subject headings: Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UrofollitrophinDrug
Also called human derived follicle stimulation hormone
Follitrophin alphaDrug
Also called Recombinant follicle stimulation hormone

Study groups in NCT01969201
Study group	Role	What they receive
Fostimon®	Experimental	75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA) Receives: Drug: Urofollitrophin
Gonal-F®	Active comparator	75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono) Receives: Drug: Follitrophin alpha

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Pregnancy Rate
A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation;
Measured: 8 weeks

Secondary outcomes (7)

Number of Follicles >16 mm on the Day of hCG Injection
Measured: 10-15 days after starting FSH stimulation
Total Number of Oocytes Retrieved
Measured: end of treatment period, approximately 2 - 3 weeks.
Fertilization Rate
Measured: end of treatment period, approximately 2 - 3 weeks
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.
Measured: On culture day 3
Positive Serum Pregnancy Test Rate
Two weeks after embryo transfer, a serum pregnancy test will be performed.
Measured: 2 weeks after embryo transfer
Delivery Rate
Measured: 9 months
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.
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Aug 2017

First posted25 Oct 2013 (estimated)
Study startJan 2014
Primary completionJun 2016
Study completionAug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for InfertilityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 710 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01969201
Sponsor's protocol ID: 13EU/FSH01
Acronym: FAST
Status last verified: Sep 2019
First submitted: 8 Oct 2013
Last updated: 9 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomised Clinical Trial Comparing Highly Purified FSH Formulation (Fostimon®) and Recombinant FSH (Gonal-F®) in GnRH-antagonist Controlled Ovarian Hyperstimulation Cycles.
ClinicalTrials.gov ID: NCT01969201
Acronym / sponsor ID: FAST / 13EU/FSH01
Conditions: Infertility
Keywords: In vitro fertilization (IVF), Assisted reproduction technologies (ART), GnRH-antagonist, Follicle stimulating hormone (FSH)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 710 participants (actual)
Lead sponsor: IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
Study start: Jan 2014 (actual)
Primary completion: Jun 2016 (actual)
Study completion: Aug 2017 (actual)
First posted: 25 Oct 2013 (estimated)
Results: Posted 9 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Fostimon®	Experimental	Drug: Urofollitrophin75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA)
Gonal-F®	Active comparator	Drug: Follitrophin alpha75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono)

Who may qualify

Ages: 18 to 38 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (16 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
UrofollitrophinAlso: human derived follicle stimulation hormone	Drug	Fostimon®
Follitrophin alphaAlso: Recombinant follicle stimulation hormone	Drug	Gonal-F®

Primary outcome

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;

7 secondary outcomes

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: end of treatment period, approximately 2 - 3 weeks.
Fertilization Rate
Time frame: end of treatment period, approximately 2 - 3 weeks
Embryo Quality (Number of Top Quality Embryos Transferred Per Patient)
Time frame: On culture day 3
Positive Serum Pregnancy Test Rate
Time frame: 2 weeks after embryo transfer
Delivery Rate
Time frame: 9 months
Cumulative Pregnancy Rate
Time frame: 2 years

Results and safety

Results posted to the registry on 9 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fostimon®	352	307
Gonal-F®	358	313

Primary outcome: Clinical Pregnancy Rate

Time frame: 8 weeks. Number. Unit: percentage of participants

Measure	Fostimon® n = 352	Gonal-F® n = 358
Value	36.93	39.66

Fostimon® vs Gonal-F®: Mean Difference (Final Values): -2.73 (95% CI -9.88 to 4.42), p = 0.49, Fisher Exact

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded from the signature of the informed consent to the end-of-trial (i.e. up to 9 months in case of a positive pregnancy).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fostimon®	24 of 352 (6.8%)	36 of 352 (10.2%)	0 of 352
Gonal-F®	31 of 358 (8.7%)	42 of 358 (11.7%)	0 of 358

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pedro Barri, MD study chair

Institut Universitari Dexeus, Barcelona, Spain

Christophe Blockeel, MD study chair

Universitair Ziekenhuis Brussel, Belgium

16 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Urofollitrophin and Follitrophin alpha in people with Infertility, run by IBSA Institut Biochimique SA at 16 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Italy, Spain, Belgium, Switzerland, Turkey (Türkiye) and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Pregnancy Rate (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01969201.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.