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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426386
• Other study ID #: 000009
• Secondary ID: 2011-000633-36
• Status: Completed
• Phase: Phase 2
• Start date: September 2011
• Est. completion date: March 2013

Study information

• Verified date: August 2018
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: March 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• FE 999049

• Gonal - F

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussels
Belgium	UZ Gent	Gent
Czechia	ICF CUBE	Prague
Denmark	Rigshospitalet	Copenhagen
Spain	IU Dexeus	Barcelona
Spain	IVI Madrid	Madrid
Spain	IVI Sevilla	Sevilla
Spain	IVI Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Czechia,  Denmark,  Spain, 

References & Publications (1)

Arce JC, Larsson P, García-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Oocytes Retrieved		Day of oocyte retrieval (up to Day 18 after start of stimulation)
Secondary	Number and Size of Follicles During Stimulation	Follicular volume at end of stimulation	End of stimulation (up to 16 stimulation days)
Secondary	Endocrine Profile	Estradiol at end of stimulation	End of stimulation (up to 16 stimulation days)
Secondary	Total IMP Dose		End of stimulation (up to 16 stimulation days)
Secondary	Number of Fertilised Oocytes	An oocyte with 2 pronuclei was regarded as correctly fertilised	Day 1 after insemination
Secondary	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	Day 5 after oocyte retrieval
Secondary	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	5-6 weeks after transfer
Secondary	Frequency and Intensity of Adverse Events		From signing informed consent form until end of trial visit (up to 5 months)