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

Infertility Clinical Trial

— FAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969201
• Other study ID #: 13EU/FSH01
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: August 2017

Study information

• Verified date: September 2019
• Source: IBSA Institut Biochimique SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 710
• Est. completion date: August 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Urofollitrophin

• Follitrophin alpha

Locations

Country	Name	City	State
Belgium	UCL- Cliniques Universitaires Saint Luc	Brussels
Belgium	Universitair Ziekenhuis Brussel	Brussels
Italy	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
Spain	Clinica IVI Alicante	Alicante
Spain	Institut Universitari Dexeus	Barcelona
Spain	Ginefiv Clínica de Fertilidad	Madrid
Spain	Instituto Valenciano de Infertilidad (IVI)	Sevilla
Switzerland	Universitäts-Frauenklinik	Basel	BS
Switzerland	Universitätsklinik für Frauenheilkunde	Bern	Be
Turkey	Prof. Bülent Urman	Istanbul
Turkey	Ege University	Izmir
United Kingdom	Midland Fertility Services	Aldridge

Sponsors (1)

Lead Sponsor	Collaborator
IBSA Institut Biochimique SA

Countries where clinical trial is conducted

Belgium,  Italy,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Pregnancy Rate	A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation;	8 weeks
Secondary	Number of Follicles >16 mm on the Day of hCG Injection		10-15 days after starting FSH stimulation
Secondary	Total Number of Oocytes Retrieved		end of treatment period, approximately 2 - 3 weeks.
Secondary	Fertilization Rate		end of treatment period, approximately 2 - 3 weeks
Secondary	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.	On culture day 3
Secondary	Positive Serum Pregnancy Test Rate	Two weeks after embryo transfer, a serum pregnancy test will be performed.	2 weeks after embryo transfer
Secondary	Delivery Rate		9 months
Secondary	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.	2 years