NCT00884221

Brief Summary

The main purpose of this clinical research trial was to compare the ongoing pregnancy rate between two gonadotrophins for controlled ovarian stimulation (MENOPUR and recombinant follicle-stimulating hormone (FSH)), in cycles where a gonadotrophin-releasing hormone (GnRH) antagonist was used for prevention of premature luteinizing hormone (LH) surge and where a single embryo was transferred at the blastocyst stage.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
749

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2009

Geographic Reach
7 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 18, 2012

Completed
Last Updated

April 20, 2012

Status Verified

April 1, 2012

Enrollment Period

1 year

First QC Date

April 17, 2009

Results QC Date

February 14, 2012

Last Update Submit

April 18, 2012

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

  • Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Intention-to-treat (ITT) Analysis Set

    Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage

    10-11 weeks after embryo transfer at the blastocyst stage

  • Ongoing Pregnancy After One Fresh Embryo Replacement Cycle, Per-protocol (PP) Analysis Set

    Transvaginal ultrasound showing at least one intrauterine viable fetus 10-11 weeks after embryo transfer at the blastocyst stage

    10-11 weeks after embryo transfer at the blastocyst stage

Secondary Outcomes (14)

  • Endocrine Profile (Estradiol), Intention-to-treat (ITT) Analysis Set

    On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

  • Endocrine Profile (FSH), Intention-to-treat (ITT) Analysis Set

    On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

  • Endocrine Profile (Free Androgen Index), Intention-to-treat (ITT) Analysis Set

    On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

  • Endocrine Profile (Luteinizing Hormone), Intention-to-treat (ITT) Analysis Set

    On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

  • Endocrine Profile (Progesterone), Intention-to-treat (ITT) Analysis Set

    On the last day of stimulation, blood was drawn at least 8 hours after the previous injection of gonadotrophin and GnRH antagonist

  • +9 more secondary outcomes

Study Arms (2)

Highly Purified Menotrophin

EXPERIMENTAL
Drug: Highly purified menotrophin

Recombinant FSH

ACTIVE COMPARATOR
Drug: Recombinant FSH

Interventions

Highly purified menotrophinDRUG

The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, dosing could be adjusted according to individual participant response. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days. NOTE: The gonadotrophins (highly purified menotrophin and the active comparator recombinant FSH) were administered in an identical fashion.

Also known as: HP-hMG, MENOPUR
Highly Purified Menotrophin
Recombinant FSHDRUG

The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, dosing could be adjusted according to individual participant response. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days. NOTE: The gonadotrophins (highly purified menotrophin and the active comparator recombinant FSH) were administered in an identical fashion.

Also known as: Follitrophin-beta, PUREGON, FOLLISTIM
Recombinant FSH

Eligibility Criteria

Age21 Years - 34 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Informed Consent Documents signed prior to screening evaluations
  • In good physical and mental health
  • Pre-menopausal females 21-34 years of age
  • Body mass index (BMI)18-25 kg/m2
  • Eligible for intracytoplasmic sperm injection (ICSI)
  • Unexplained infertility or partner with mild male factor infertility
  • Infertility for at least 12 months before randomization
  • Regular menstrual cycles of 24-35 days, presumed to be ovulatory
  • Hysterosalpingography, hysteroscopy, or transvaginal ultrasound documenting a uterus consistent with expected normal function
  • Transvaginal ultrasound documenting expected normal function of the ovaries
  • Early follicular phase serum levels of FSH between 1 and 12 IU/L
  • Early follicular phase total antral follicle (diameter 2-10 mm) count ≥ 10 for both ovaries combined
  • Willing to accept transfer of one blastocyst in the fresh cycle
  • Willing to undergo frozen embryo replacement cycles with transfer of one blastocyst per cycle within the first year after randomisation

You may not qualify if:

  • Known polycystic ovarian syndrome or known endometriosis stage I-IV
  • Diagnosed as "poor responder" in a previous controlled ovarian stimulation (COS) cycle
  • Severe ovarian hyperstimulation syndrome (OHSS)in a previous COS cycle
  • History of recurrent miscarriage
  • Current or past (12 months prior to randomization) abuse of alcohol or drugs, and/or current (last month) intake of more than 14 units of alcohol per week
  • Current or past smoking habit of more than 10 cigarettes per day
  • Hypersensitivity to any active ingredient or excipients in the medicinal products used in the trial
  • Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue
  • Previous participation in the trial
  • Use of any non registered investigational drugs during 3 months before randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

ERASME Hospital

Anderlecht, Belgium

Location

UZ Brussel

Brussels, Belgium

Location

UZ Antwerpen

Edegem, Belgium

Location

UZ Gent

Ghent, Belgium

Location

IVF Institute

Pilsen, Czechia

Location

ISCARE IVF a.s.

Prague, Czechia

Location

Pronatal

Prague, Czechia

Location

H:S Rigshospitalet

Copenhagen, Denmark

Location

Amtssygehuset Herlev

Herlev, Denmark

Location

Sygehus Vestsjælland

Holbæk, Denmark

Location

H:S Hvidovre Hospital

Hvidovre, Denmark

Location

KRIOBANK

Bialystok, Poland

Location

nOvum

Warsaw, Poland

Location

IU Dexeus

Barcelona, Spain

Location

GINEFIV, Madrid

Madrid, Spain

Location

IVI Madrid

Madrid, Spain

Location

Ginemed

Seville, Spain

Location

IVI Sevilla

Seville, Spain

Location

IVI Valencia

Valencia, Spain

Location

Fertilitetscentrum AB Gothenburg

Gothenburg, Sweden

Location

IVF-kliniken CURA

Malmo, Sweden

Location

RMC, Malmö

Malmo, Sweden

Location

Hacettepe University

Ankara, Turkey (Türkiye)

Location

American Hospital

Istanbul, Turkey (Türkiye)

Location

Memorial Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • Devroey P, Pellicer A, Nyboe Andersen A, Arce JC; Menopur in GnRH Antagonist Cycles with Single Embryo Transfer Trial Group. A randomized assessor-blind trial comparing highly purified hMG and recombinant FSH in a GnRH antagonist cycle with compulsory single-blastocyst transfer. Fertil Steril. 2012 Mar;97(3):561-71. doi: 10.1016/j.fertnstert.2011.12.016. Epub 2012 Jan 13.

    PMID: 22244781RESULT

  • Arce JC, La Marca A, Mirner Klein B, Nyboe Andersen A, Fleming R. Antimullerian hormone in gonadotropin releasing-hormone antagonist cycles: prediction of ovarian response and cumulative treatment outcome in good-prognosis patients. Fertil Steril. 2013 May;99(6):1644-53. doi: 10.1016/j.fertnstert.2012.12.048. Epub 2013 Feb 5.

    PMID: 23394782DERIVED

MeSH Terms

Conditions

Infertility

Interventions

MenotropinsGlycoprotein Hormones, alpha Subunitfollitropin beta

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and ProteinsBiological ProductsComplex MixturesChorionic GonadotropinFollicle Stimulating HormoneLuteinizing HormoneThyrotropinPlacental Hormones

Results Point of Contact

Title
Ferring Pharmaceuticals
Organization
Clinical Development Support
DK0-Disclosure@ferring.com

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2009

First Posted

April 20, 2009

Study Start

July 1, 2009

Primary Completion

July 1, 2010

Study Completion

January 1, 2011

Last Updated

April 20, 2012

Results First Posted

April 18, 2012

Record last verified: 2012-04

Locations

TU(3)CZ(3)PL(2)ES(6)SE(3)DK(4)BE(4)