A Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation.
NCT ID: NCT03564509
Last Updated: 2023-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
620 participants
INTERVENTIONAL
2018-05-14
2020-01-08
Brief Summary
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Furthermore, the study intends:
* To investigate the safety of FE 999302 in women undergoing COS with follitropin delta in a long GnRH agonist protocol.
* To investigate the potential immunogenicity of FE 999302 in subjects undergoing COS with follitropin delta in a long GnRH agonist protocol.
* To estimate the impact of body weight on FE 999302 exposure in subjects undergoing COS with follitropin delta in a long GnRH agonist protocol.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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FE 999302 (1 μg) and follitropin delta
FE 999302 (1 μg) and follitropin delta
Daily dose of 1 μg of FE 999302, a recombinant human chorionic gonadotropin (rhCG) solution for subcutaneous injection; individualized follitropin delta dose.
FE 999302 (2 μg) and follitropin delta
FE 999302 (2 μg) and follitropin delta
Daily dose of 2 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.
FE 999302 (4 μg) and follitropin delta
FE 999302 (4 μg) and follitropin delta
Daily dose of 4 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.
FE 999302 (8 μg) and follitropin delta
FE 999302 (8 μg) and follitropin delta
Daily dose of 8 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.
FE 999302 (12 μg) and follitropin delta
FE 999302 (12 μg) and follitropin delta
Daily dose of 12 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.
Placebo and follitropin delta
Placebo and follitropin delta
Daily dose of placebo; individualized follitropin delta dose.
Interventions
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FE 999302 (1 μg) and follitropin delta
Daily dose of 1 μg of FE 999302, a recombinant human chorionic gonadotropin (rhCG) solution for subcutaneous injection; individualized follitropin delta dose.
FE 999302 (2 μg) and follitropin delta
Daily dose of 2 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.
FE 999302 (4 μg) and follitropin delta
Daily dose of 4 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.
FE 999302 (8 μg) and follitropin delta
Daily dose of 8 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.
FE 999302 (12 μg) and follitropin delta
Daily dose of 12 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.
Placebo and follitropin delta
Daily dose of placebo; individualized follitropin delta dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In good physical and mental health as judged by the investigator.
* Anti-Müllerian hormone (AMH) levels at screening of 5.0-35.0 pmol/L (as measured by Elecsys® AMH Plus Immunoassay \[Roche Diagnostics\] at central laboratory).
* Pre-menopausal women between the ages of 30 and 42 years. The subjects must be at least 30 years (including the 30th birthday) and no more than 42 years (up to the day before the 43rd birthday) when they sign the informed consent.
* Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation and/or intracytoplasmic sperm injection using fresh or frozen ejaculated sperm from male partner or sperm donor.
* Infertility for at least 1 year before screening for subjects less than 35 years or for at least 6 months for subjects greater than equal to (≥)35 years (not applicable in case of tubal or severe male factor infertility).
Exclusion Criteria
* One or more follicles ≥10 mm (including cysts) observed on the transvaginal ultrasound after down-regulation prior to randomisation on stimulation day 1 (puncture of cysts is allowed prior to randomisation).
* Pregnancy (negative pregnancy tests must be documented at screening and prior to start of down-regulation) or contraindication to pregnancy.
30 Years
42 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Universitair Ziekenhuis Gent (UZ Gent)
Ghent, , Belgium
Universitair Ziekenhuis Brussel
Jette, , Belgium
Institut fur Reproduktionsmedizin und Genetik
Karlovy Vary, , Czechia
Fertimed
Olomouc, , Czechia
GYNEM
Prague, , Czechia
IVF CUBE
Prague, , Czechia
Aalborg University Hospital
Aalborg, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Dansk Fertilitetsklinik
Frederiksberg, , Denmark
Hvidovre Hospital
Hvidovre, , Denmark
Dexeus Woman's Health
Barcelona, , Spain
Instituto Valenciano de Infertilidad (IVI) - Bilbao
Leioa, , Spain
GINEFIV - Clinica Belen Location
Madrid, , Spain
Instituto Valenciano de Infertilidad (IVI) - Madrid
Madrid, , Spain
Instituto Valenciano de Infertilidad (IVI) - Sevilla
Seville, , Spain
Instituto Valenciano de Infertilidad (IVI) - Valencia
Valencia, , Spain
Glasgow Royal Infirmary
Glasgow, , United Kingdom
Liverpool Women's Hospital
Liverpool, , United Kingdom
Guy's and St Thomas' NHS Trust
London, , United Kingdom
Kings College (Assisted Conception Unit)
London, , United Kingdom
Countries
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References
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Sanchez MF, Larsson P, Serrano MF, Bosch E, Velasco JAG, Lopez ES, Mannaerts B. Live birth rates following individualized dosing algorithm of follitropin delta in a long GnRH agonist protocol. Reprod Biol Endocrinol. 2023 May 16;21(1):45. doi: 10.1186/s12958-023-01090-w.
Other Identifiers
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2017-003810-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
000289
Identifier Type: -
Identifier Source: org_study_id
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