MENOPUR in GnRH Antagonist Cycles With Single Embryo Transfer

Condition(s) targeted: Infertility

Intervention: Menotrophin (Drug); Follitrophin-beta (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Ferring Pharmaceuticals

Official(s) and/or principal investigator(s):
Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals

Overall contact:
Clinical Development Support, Email: DK0-Disclosure@ferring.com

The main purpose of this clinical research trial is to compare the pregnancy rate between two gonadotrophins for controlled ovarian stimulation (MENOPUR and recombinant FSH), in cycles where a GnRH antagonist is used for prevention of premature LH surge.

Official title: A Randomised, Open-label, Assessor-blind, Parallel Groups, Multicentre Trial Comparing the Efficacy of MENOPUR Versus Recombinant FSH in Controlled Ovarian Stimulation Following a GnRH Antagonist Protocol and Single Embryo Transfer

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary outcome: Ongoing Pregnancy

Secondary outcome:

Endocrine profile

Follicular development

Embryo quality

Minimum age: 21 Years. Maximum age: 34 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Subjects should be 21-34 years old, have early follicular FSH levels between 1 and 12

IU/L and antral follicle count ≥ 10, regular menstrual cycles of 24-35 days presumed to be ovulatory, as well as having been infertile for at least 12 months.

Exclusion Criteria:

- Subjects with known polycystic ovarian syndrome, known endometriosis stage I-IV or

diagnosed as poor responders will be excluded.

Clinical Development Support, Email: DK0-Disclosure@ferring.com

ERASME Hospital, Anderlecht, Belgium; Not yet recruiting

UZ Brussel, Brussels, Belgium; Active, not recruiting

UZ Gent, Gent, Belgium; Not yet recruiting

KUL Leuven, Leuven, Belgium; Not yet recruiting

UZ Antwerpen, Edegem, Belgium; Active, not recruiting

Pronatal, Prague, Czech Republic; Not yet recruiting

ISCARE IVF a.s., Prague, Czech Republic; Recruiting

Plzen, Plzen, Czech Republic; Recruiting

Sygehus Vestsjælland, Holbæk, Denmark; Active, not recruiting

H:S Hvidovre Hospital, Hvidovre, Denmark; Active, not recruiting

H:S Rigshospitalet, København, Denmark; Recruiting

Amtssygehuset Herlev, Herlev, Denmark; Not yet recruiting

KRIOBANK, Bialystok, Poland; Not yet recruiting

nOvum, Warszawa, Poland; Not yet recruiting

IU Dexeus, Barcelona, Spain; Not yet recruiting

IVI Madrid, Madrid, Spain; Active, not recruiting

GINEFIV, Madrid, Madrid, Spain; Not yet recruiting

IVI Sevilla, Sevilla, Spain; Not yet recruiting

Ginemed, Sevilla, Spain; Not yet recruiting

IVI Valencia, Valencia, Spain; Not yet recruiting

IVF-kliniken CURA, Malmö, Sweden; Not yet recruiting

Fertilitetscentrum AB Göteborg, Göteborg, Sweden; Not yet recruiting

Sahlgrenska, Stockholm, Sweden; Not yet recruiting

RMC, Malmö, Malmö, Sweden; Not yet recruiting

Zekai Tahir Burak Hospital, Ankara, Turkey; Not yet recruiting

Ege University, Izmir, Turkey; Not yet recruiting

Hacettepe University, Ankara, Turkey; Not yet recruiting

American Hospital, Istanbul, Turkey; Not yet recruiting

Memorial Hospital, Istanbul, Turkey; Not yet recruiting

Starting date: July 2009
Last updated: September 9, 2009