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

Phase 4

Completed

• Conditions: Infertility
• Interventions: Drug: Follitrophin alpha; Drug: Urofollitrophin

• Registration Number: NCT01969201
• Lead Sponsor: IBSA Institut Biochimique SA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-24
• Study First Posted: 2013-10-25
• Study Start: 2014-01
• Primary Completion: 2016-06
• Study Completion: 2017-08
• Results First Submitted: 2018-12-12
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-19
• Last Update Submitted: 2019-09-19
• Results First Posted: 2019-10-09
• Last Update Posted: 2019-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 710

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gonal-F®	Follitrophin alpha	75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono)
Fostimon®	Urofollitrophin	75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Delivery Rate	9 months
Cumulative Pregnancy Rate	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.
Embryo Quality (Number of Top Quality Embryos Transferred Per Patient)	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.
Positive Serum Pregnancy Test Rate	2 weeks after embryo transfer	Two weeks after embryo transfer, a serum pregnancy test will be performed.
Number of Follicles >16 mm on the Day of hCG Injection	10-15 days after starting FSH stimulation
Total Number of Oocytes Retrieved	end of treatment period, approximately 2 - 3 weeks.
Fertilization Rate	end of treatment period, approximately 2 - 3 weeks

Trial Locations

Locations (16)

Universitätsklinik für Frauenheilkunde; 🇨🇭 Bern, Be, Switzerland

IRCCS San Raffaele; 🇮🇹 Milan, Italy

Universitair Ziekenhuis Brussel; 🇧🇪 Brussels, Belgium

Azienda Ospedaliera Di Reggio Emilia; 🇮🇹 Reggio Emilia, Italy

Clinica IVI Alicante; 🇪🇸 Alicante, Spain

Universitäts-Frauenklinik; 🇨🇭 Basel, BS, Switzerland

Instituto Valenciano de Infertilidad (IVI); 🇪🇸 Sevilla, Spain

Prof. Bülent Urman; 🇹🇷 Istanbul, Turkey

UCL- Cliniques Universitaires Saint Luc; 🇧🇪 Brussels, Belgium

Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Fondazione Ca'Granda, Osp Maggiore Policlinico; 🇮🇹 Milan, Italy

Institut Universitari Dexeus; 🇪🇸 Barcelona, Spain

Università degli Studi di Napoli 'Federico II'; 🇮🇹 Naples, Italy

Ginefiv Clínica de Fertilidad; 🇪🇸 Madrid, Spain

Ege University; 🇹🇷 Izmir, Turkey

Midland Fertility Services; 🇬🇧 Aldridge, United Kingdom