Infertility Clinical Trial
— FASTOfficial title:
Randomised Clinical Trial Comparing Highly Purified FSH Formulation (Fostimon®) and Recombinant FSH (Gonal-F®) in GnRH-antagonist Controlled Ovarian Hyperstimulation Cycles.
NCT number | NCT01969201 |
Other study ID # | 13EU/FSH01 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | January 2014 |
Est. completion date | August 2017 |
Verified date | September 2019 |
Source | IBSA Institut Biochimique SA |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
IBSA Institut Biochimique SA |
Belgium, Italy, Spain, Switzerland, Turkey, United Kingdom,
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 |
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