NCT01426386

Brief Summary

This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
265

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_2

Geographic Reach
4 countries

8 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

August 30, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

August 3, 2018

Completed
Last Updated

November 17, 2020

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

August 30, 2011

Results QC Date

May 31, 2018

Last Update Submit

October 26, 2020

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Number of Oocytes Retrieved

    Day of oocyte retrieval (up to Day 18 after start of stimulation)

Secondary Outcomes (7)

  • Number and Size of Follicles During Stimulation

    End of stimulation (up to 16 stimulation days)

  • Endocrine Profile

    End of stimulation (up to 16 stimulation days)

  • Total IMP Dose

    End of stimulation (up to 16 stimulation days)

  • Number of Fertilised Oocytes

    Day 1 after insemination

  • Number and Quality of Blastocysts on Day 5

    Day 5 after oocyte retrieval

  • +2 more secondary outcomes

Study Arms (6)

5.2 µg

EXPERIMENTAL
Drug: FE 999049

6.9 µg

EXPERIMENTAL
Drug: FE 999049

8.6 µg

EXPERIMENTAL
Drug: FE 999049

10.3 µg

EXPERIMENTAL
Drug: FE 999049

12.1 µg

EXPERIMENTAL
Drug: FE 999049

11 µg FbM (150 IU)

ACTIVE COMPARATOR
Drug: Gonal - F

Interventions

FE 999049DRUG
10.3 µg12.1 µg5.2 µg6.9 µg8.6 µg
Gonal - FDRUG
11 µg FbM (150 IU)

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women diagnosed with tubal infertility, unexplained infertility, infertility related to endometriosis stage I/II or with partners diagnosed with male factor infertility
  • Women eligible for IVF (in-vitro fertilisation) and/or ICSI (intracytoplasmic sperm injection) treatment
  • Women aged 18-37 years
  • Women with body mass index (BMI) of 18.5-32.0 kg/m2

You may not qualify if:

  • Women with polycystic ovary syndrome (PCOS) associated with anovulation, endometriosis stage III/IV
  • Women with history of recurrent miscarriage
  • Women with contraindications to controlled ovarian stimulation with gonadotropins
  • Women with three or more controlled ovarian stimulation cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

UZ Brussel

Brussels, Belgium

Location

UZ Gent

Ghent, Belgium

Location

ICF CUBE

Prague, Czechia

Location

Rigshospitalet

Copenhagen, Denmark

Location

IU Dexeus

Barcelona, Spain

Location

IVI Madrid

Madrid, Spain

Location

IVI Sevilla

Seville, Spain

Location

IVI Valencia

Valencia, Spain

Location

Related Publications (2)

  • Arce JC, Larsson P, Garcia-Velasco JA. Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa. Reprod Biomed Online. 2020 Oct;41(4):616-622. doi: 10.1016/j.rbmo.2020.07.006. Epub 2020 Jul 15.

    PMID: 32819842RESULT

  • Arce JC, Andersen AN, Fernandez-Sanchez M, Visnova H, Bosch E, Garcia-Velasco JA, Barri P, de Sutter P, Klein BM, Fauser BC. Ovarian response to recombinant human follicle-stimulating hormone: a randomized, antimullerian hormone-stratified, dose-response trial in women undergoing in vitro fertilization/intracytoplasmic sperm injection. Fertil Steril. 2014 Dec;102(6):1633-40.e5. doi: 10.1016/j.fertnstert.2014.08.013. Epub 2014 Sep 23.

    PMID: 25256937DERIVED

MeSH Terms

Conditions

Infertility

Interventions

FE 999049Glycoprotein Hormones, alpha Subunit

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Chorionic GonadotropinGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsFollicle Stimulating HormoneGonadotropins, PituitaryLuteinizing HormonePituitary Hormones, AnteriorPituitary HormonesThyrotropinPlacental HormonesPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Global Clinical Compliance
Organization
Ferring Pharmaceuticals
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 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2011

First Posted

August 31, 2011

Study Start

September 1, 2011

Primary Completion

April 1, 2012

Study Completion

March 1, 2013

Last Updated

November 17, 2020

Results First Posted

August 3, 2018

Record last verified: 2018-08

Locations

BE(2)DK(1)ES(4)CZ(1)