Clinical trial NCT01969201: FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: In vitro fertilization (IVF)
Assisted reproduction technologies (ART)
GnRH-antagonist
Follicle stimulating hormone (FSH)
Lead sponsor: IBSA Institut Biochimique SA
Sponsor class: INDUSTRY
First posted: 2013-10-25
Enrollment: 710
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: 8 weeks
Secondary outcomes:
measure: Number of Follicles >16 mm on the Day of hCG Injection
timeFrame: 10-15 days after starting FSH stimulation
measure: Total Number of Oocytes Retrieved
timeFrame: end of treatment period, approximately 2 - 3 weeks.
measure: Fertilization Rate
timeFrame: end of treatment period, approximately 2 - 3 weeks
measure: Embryo Quality (Number of Top Quality Embryos Transferred Per Patient)
timeFrame: On culture day 3
measure: Positive Serum Pregnancy Test Rate
timeFrame: 2 weeks after embryo transfer
measure: Delivery Rate
timeFrame: 9 months
measure: Cumulative Pregnancy Rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UCL- Cliniques Universitaires Saint Luc
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Milan
country: Italy
facility: Fondazione Ca'Granda, Osp Maggiore Policlinico
city: Milan
country: Italy
facility: IRCCS San Raffaele
city: Naples
country: Italy
facility: Università degli Studi di Napoli 'Federico II'
city: Reggio Emilia
country: Italy
facility: Azienda Ospedaliera Di Reggio Emilia
city: Alicante
country: Spain
facility: Clinica IVI Alicante
city: Barcelona
country: Spain
facility: Institut Universitari Dexeus
city: Madrid
country: Spain
facility: Ginefiv Clínica de Fertilidad
city: Sevilla
country: Spain
facility: Instituto Valenciano de Infertilidad (IVI)
city: Bern
country: Switzerland
facility: Universitätsklinik für Frauenheilkunde
state: Be
city: Basel
country: Switzerland
facility: Universitäts-Frauenklinik
state: BS
city: Istanbul
country: Turkey
facility: Prof. Bülent Urman
city: Izmir
country: Turkey
facility: Ege University
city: Aldridge
country: United Kingdom
facility: Midland Fertility Services
Study officials:
affiliation: Institut Universitari Dexeus, Barcelona, Spain
name: Pedro Barri, MD
role: STUDY_CHAIR
affiliation: Universitair Ziekenhuis Brussel, Belgium
name: Christophe Blockeel, MD
role: STUDY_CHAIR
References: