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A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment

Primary Purpose

Infertility

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
FE 999049
Gonal - F
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

18 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • UZ Brussel
  • UZ Gent
  • ICF CUBE
  • Rigshospitalet
  • IU Dexeus
  • IVI Madrid
  • IVI Sevilla
  • IVI Valencia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

5.2 µg

6.9 µg

8.6 µg

10.3 µg

12.1 µg

11 µg FbM (150 IU)

Arm Description

Outcomes

Primary Outcome Measures

Number of Oocytes Retrieved

Secondary Outcome Measures

Number and Size of Follicles During Stimulation
Follicular volume at end of stimulation
Endocrine Profile
Estradiol at end of stimulation
Total IMP Dose
Number of Fertilised Oocytes
An oocyte with 2 pronuclei was regarded as correctly fertilised
Number and Quality of Blastocysts on Day 5
Number of blastocysts (total and good-quality) on Day 5 are presented. A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher
Clinical Pregnancy With Fetal Heart Beat Rate
Clinical pregnancy with fetal heart beat was defined as at least one intrauterine gestational sac with fetal heart beat
Frequency and Intensity of Adverse Events

Full Information

First Posted
August 30, 2011
Last Updated
October 26, 2020
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01426386
Brief Title
A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment
Official Title
A Randomised, Controlled, Assessor-blind, Parallel Groups, Multi-national, Multi-centre Trial Assessing the Dose-response Relationship of FE 999049 in Controlled Ovarian Stimulation in Women Undergoing an ART Programme
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5.2 µg
Arm Type
Experimental
Arm Title
6.9 µg
Arm Type
Experimental
Arm Title
8.6 µg
Arm Type
Experimental
Arm Title
10.3 µg
Arm Type
Experimental
Arm Title
12.1 µg
Arm Type
Experimental
Arm Title
11 µg FbM (150 IU)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
FE 999049
Intervention Type
Drug
Intervention Name(s)
Gonal - F
Primary Outcome Measure Information:
Title
Number of Oocytes Retrieved
Time Frame
Day of oocyte retrieval (up to Day 18 after start of stimulation)
Secondary Outcome Measure Information:
Title
Number and Size of Follicles During Stimulation
Description
Follicular volume at end of stimulation
Time Frame
End of stimulation (up to 16 stimulation days)
Title
Endocrine Profile
Description
Estradiol at end of stimulation
Time Frame
End of stimulation (up to 16 stimulation days)
Title
Total IMP Dose
Time Frame
End of stimulation (up to 16 stimulation days)
Title
Number of Fertilised Oocytes
Description
An oocyte with 2 pronuclei was regarded as correctly fertilised
Time Frame
Day 1 after insemination
Title
Number and Quality of Blastocysts on Day 5
Description
Number of blastocysts (total and good-quality) on Day 5 are presented. A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher
Time Frame
Day 5 after oocyte retrieval
Title
Clinical Pregnancy With Fetal Heart Beat Rate
Description
Clinical pregnancy with fetal heart beat was defined as at least one intrauterine gestational sac with fetal heart beat
Time Frame
5-6 weeks after transfer
Title
Frequency and Intensity of Adverse Events
Time Frame
From signing informed consent form until end of trial visit (up to 5 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
UZ Brussel
City
Brussels
Country
Belgium
Facility Name
UZ Gent
City
Gent
Country
Belgium
Facility Name
ICF CUBE
City
Prague
Country
Czechia
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
IU Dexeus
City
Barcelona
Country
Spain
Facility Name
IVI Madrid
City
Madrid
Country
Spain
Facility Name
IVI Sevilla
City
Sevilla
Country
Spain
Facility Name
IVI Valencia
City
Valencia
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
32819842
Citation
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.
Results Reference
result
PubMed Identifier
25256937
Citation
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.
Results Reference
derived

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A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment

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