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

NCT01969201 | Completed Phase 4 Results

• 1 other identifier: 13EU/FSH01
• Study Type: interventional
• Target: 710
• Locations: 6 countries
• Sites: 16

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.

Conditions

Infertility

Keywords

In vitro fertilization (IVF); Assisted reproduction technologies (ART); GnRH-antagonist; Follicle stimulating hormone (FSH)

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy Rate

  A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation;

  8 weeks

Secondary Outcomes (7)

• 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

• Embryo Quality (Number of Top Quality Embryos Transferred Per Patient)

  On culture day 3

• Positive Serum Pregnancy Test Rate

  2 weeks after embryo transfer

Study Arms (2)

Fostimon®

EXPERIMENTAL

75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA)

Drug: Urofollitrophin

Gonal-F®

ACTIVE COMPARATOR

75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono)

Drug: Follitrophin alpha

Interventions

Urofollitrophin DRUG

Also known as: human derived follicle stimulation hormone

Fostimon®

Follitrophin alpha DRUG

Also known as: Recombinant follicle stimulation hormone

Gonal-F®

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

Study Sites (16)

UCL- Cliniques Universitaires Saint Luc

Brussels, Belgium

Location

Universitair Ziekenhuis Brussel

Brussels, Belgium

Location

Spedali Civili di Brescia

Brescia, Italy

Location

Fondazione Ca'Granda, Osp Maggiore Policlinico

Milan, Italy

Location

IRCCS San Raffaele

Milan, Italy

Location

Università degli Studi di Napoli 'Federico II'

Naples, Italy

Location

Azienda Ospedaliera Di Reggio Emilia

Reggio Emilia, Italy

Location

Clinica IVI Alicante

Alicante, 03015, Spain

Location

Institut Universitari Dexeus

Barcelona, 8028, Spain

Location

Ginefiv Clínica de Fertilidad

Madrid, Spain

Location

Instituto Valenciano de Infertilidad (IVI)

Seville, 40011, Spain

Location

Universitäts-Frauenklinik

Basel, Canton of Basel-City, Switzerland

Location

Universitätsklinik für Frauenheilkunde

Bern, Canton of Bern, Switzerland

Location

Prof. Bülent Urman

Istanbul, Turkey (Türkiye)

Location

Ege University

Izmir, Turkey (Türkiye)

Location

Midland Fertility Services

Aldridge, United Kingdom

Location

MeSH Terms

Conditions

Infertility

Interventions

Urofollitropin; Glycoprotein Hormones, alpha Subunit

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Menotropins; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Chorionic Gonadotropin; Follicle Stimulating Hormone; Luteinizing Hormone; Thyrotropin; Placental Hormones

Results Point of Contact

• Title: Project Leader
• Organization: IBSA Insitut Biochimique

rd@ibsa.ch

+41 58 360 10 00

Study Officials

• Pedro Barri, MD

  Institut Universitari Dexeus, Barcelona, Spain

  STUDY CHAIR

• Christophe Blockeel, MD

  Universitair Ziekenhuis Brussel, Belgium

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 25, 2013
• Study Start: January 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2017
• Last Updated: October 9, 2019
• Results First Posted: October 9, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); BE (2); ES (4); IT (5); CH (2); TU (2)