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

Phase 2

Completed

• Conditions: Infertility
• Interventions: Drug: FE 999049; Drug: Gonal - F

• Registration Number: NCT01426386
• Lead Sponsor: Ferring Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-30
• Study First Submitted QC: 2011-08-30
• Study First Posted: 2011-08-31
• Study Start: 2011-09
• Primary Completion: 2012-04
• Study Completion: 2013-03
• Disposition First Submitted: 2013-04-12
• Disposition First Submitted QC: 2013-04-12
• Disposition First Posted: 2013-04-19
• Results First Submitted: 2018-05-31
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-01
• Results First Posted: 2018-08-03
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 265

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10.3 µg	FE 999049	-
6.9 µg	FE 999049	-
8.6 µg	FE 999049	-
5.2 µg	FE 999049	-
12.1 µg	FE 999049	-
11 µg FbM (150 IU)	Gonal - F	-

Primary Outcome Measures

Name	Time	Method
Number of Oocytes Retrieved	Day of oocyte retrieval (up to Day 18 after start of stimulation)

Secondary Outcome Measures

Name	Time	Method
Clinical Pregnancy With Fetal Heart Beat Rate	5-6 weeks after transfer	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	From signing informed consent form until end of trial visit (up to 5 months)
Number and Size of Follicles During Stimulation	End of stimulation (up to 16 stimulation days)	Follicular volume at end of stimulation
Endocrine Profile	End of stimulation (up to 16 stimulation days)	Estradiol at end of stimulation
Total IMP Dose	End of stimulation (up to 16 stimulation days)
Number of Fertilised Oocytes	Day 1 after insemination	An oocyte with 2 pronuclei was regarded as correctly fertilised
Number and Quality of Blastocysts on Day 5	Day 5 after oocyte retrieval	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

Trial Locations

Locations (8)

UZ Gent; 🇧🇪 Gent, Belgium

ICF CUBE; 🇨🇿 Prague, Czechia

IVI Sevilla; 🇪🇸 Sevilla, Spain

IVI Madrid; 🇪🇸 Madrid, Spain

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

IU Dexeus; 🇪🇸 Barcelona, Spain

UZ Brussel; 🇧🇪 Brussels, Belgium

IVI Valencia; 🇪🇸 Valencia, Spain