Clinical trial NCT01426386: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-08-31
Enrollment: 265
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Oocytes Retrieved
timeFrame: Day of oocyte retrieval (up to Day 18 after start of stimulation)
Secondary outcomes:
measure: Number and Size of Follicles During Stimulation
timeFrame: End of stimulation (up to 16 stimulation days)
measure: Endocrine Profile
timeFrame: End of stimulation (up to 16 stimulation days)
measure: Total IMP Dose
timeFrame: End of stimulation (up to 16 stimulation days)
measure: Number of Fertilised Oocytes
timeFrame: Day 1 after insemination
measure: Number and Quality of Blastocysts on Day 5
timeFrame: Day 5 after oocyte retrieval
measure: Clinical Pregnancy With Fetal Heart Beat Rate
timeFrame: 5-6 weeks after transfer
measure: Frequency and Intensity of Adverse Events
timeFrame: From signing informed consent form until end of trial visit (up to 5 months)
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel
city: Gent
country: Belgium
facility: UZ Gent
city: Prague
country: Czechia
facility: ICF CUBE
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Barcelona
country: Spain
facility: IU Dexeus
city: Madrid
country: Spain
facility: IVI Madrid
city: Sevilla
country: Spain
facility: IVI Sevilla
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
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.
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.