FSH in GnRH-antagonist Controlled Ovarian Hyperstimulation Cycles

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by IBSA Institut Biochimique SA
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier:
NCT01969201
First received: October 8, 2013
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: Urofollitrophin
Drug: Follitrophin alpha
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Randomised Clinical Trial Comparing Highly Purified FSH Formulation (Fostimon®) and Recombinant FSH (Gonal-F®) in GnRH-antagonist Controlled Ovarian Hyperstimulation Cycles.

Resource links provided by NLM:


Further study details as provided by IBSA Institut Biochimique SA:

Primary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation;


Secondary Outcome Measures:
  • Number of follicles >16 mm on the day of hCG injection [ Time Frame: 10-15 days after starting FSH stimulation ] [ Designated as safety issue: No ]
  • Total number of oocytes retrieved [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]
  • Fertilization rate [ Time Frame: 2-3 weeks ] [ Designated as safety issue: No ]
  • Embryo quality [ Time Frame: On culture day 3 ] [ Designated as safety issue: No ]
    Quality of the embryos will be evaluated just before embryo transfer on Day 3.

  • Positive serum pregnancy test [ Time Frame: 2 weeks after embryo transfer ] [ Designated as safety issue: No ]
    Two weeks after embryo transfer, a serum pregnancy test will be performed.

  • Delivery rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Cumulative pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 720
Study Start Date: January 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fostimon®
75 IU/vial, powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone,IBSA Institut Biochimique SA)
Drug: Urofollitrophin
Other Name: human derived follicle stimulation hormone
Active Comparator: Gonal-F®
75 IU/vial powder and solvent for solution for subcutaneous injection (Follicle Stimulating Hormone; Merck Serono)
Drug: Follitrophin alpha
Other Name: Recombinant follicle stimulation hormone

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 antral follicles 2-10 mm in size for both ovaries combined
  • AMH: >1 ng/ml (7.15 pmol/l) and <4 ng/ml (28.6 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01969201

Contacts
Contact: Barbara PS Cometti, PHD barbara.cometti@ibsa.ch

Locations
Belgium
Universitair Ziekenhuis Brussel Recruiting
Brussels, Belgium
Contact: Christophe Blockeel         
Principal Investigator: Christophe Blockeel, MD         
UCL- Cliniques Universitaires Saint Luc Recruiting
Brussels, Belgium
Contact: Christine Wyns, MD         
Italy
Spedali Civili di Brescia Recruiting
Brescia, Italy
Contact: Umberto Omodei         
Fondazione Ca'Granda, Osp Maggiore Policlinico Recruiting
Milan, Italy
Contact: Edgardo Somigliana         
IRCCS San Raffaele Recruiting
Milan, Italy
Contact: Massimo Candiani         
Principal Investigator: Enrico Papaleo, MD         
Università degli Studi di Napoli 'Federico II' Recruiting
Naples, Italy
Contact: Giuseppe De Placido         
Azienda Ospedaliera Di Reggio Emilia Recruiting
Reggio Emilia, Italy
Contact: Giovanni Battista La Sala         
Spain
Clinica IVI Alicante Recruiting
Alicante, Spain, 03015
Contact: Manuel Munoz         
Principal Investigator: Manuel Munoz, MD         
Institut Universitari Dexeus Recruiting
Barcelona, Spain, 8028
Contact: Pedro Barri, MD         
Principal Investigator: Pedro Barri, MD         
Ginefiv Clínica de Fertilidad Recruiting
Madrid, Spain
Contact: Victoria Verdù         
Principal Investigator: Victoria Verdù, MD         
Instituto Valenciano de Infertilidad (IVI) Recruiting
Sevilla, Spain, 40011
Contact: Cinzia Caligara         
Principal Investigator: Cinzia Caligara, MD         
Switzerland
Universitätsklinik für Frauenheilkunde Recruiting
Bern, Be, Switzerland
Contact: Micheal von Wolf         
Universitäts-Frauenklinik Recruiting
Basel, BS, Switzerland
Contact: Christian De Geyter         
Turkey
Prof. Bülent Urman Not yet recruiting
Istanbul, Turkey
Contact: Bülent Urman, MD         
Ege University Not yet recruiting
Izmir, Turkey
Contact: Erol Tavmergen, MD         
United Kingdom
Midland Fertility Services Recruiting
Aldridge, United Kingdom
Contact: Gillian Lockwood         
Principal Investigator: Gillian Lockwood, MD         
Sponsors and Collaborators
IBSA Institut Biochimique SA
Investigators
Study Chair: Pedro Barri, MD Institut Universitari Dexeus, Barcelona, Spain
Study Chair: Christophe Blockeel, MD Universitair Ziekenhuis Brussel, Belgium
  More Information

No publications provided

Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT01969201     History of Changes
Other Study ID Numbers: 13EU/FSH01
Study First Received: October 8, 2013
Last Updated: July 3, 2014
Health Authority: Italy: The Italian Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
Turkey: Ministry of Health

Keywords provided by IBSA Institut Biochimique SA:
In vitro fertilization (IVF)
Assisted reproduction technologies (ART)
GnRH-antagonist
Follicle stimulating hormone (FSH)

Additional relevant MeSH terms:
Genital Diseases, Male
Infertility
Ovarian Hyperstimulation Syndrome
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Hormones
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014