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.

PHASE2CompletedINTERVENTIONAL
Enrollment

620

Participants

Timeline

Start Date

May 14, 2018

Primary Completion Date

October 21, 2019

Study Completion Date

January 8, 2020

Conditions
Controlled Ovarian Stimulation
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

OTHER

Placebo and follitropin delta

Daily dose of placebo; individualized follitropin delta dose.

Trial Locations (20)

Unknown

Universitair Ziekenhuis Gent (UZ Gent), Ghent

Universitair Ziekenhuis Brussel, Jette

Institut fur Reproduktionsmedizin und Genetik, Karlovy Vary

Fertimed, Olomouc

GYNEM, Prague

IVF CUBE, Prague

Aalborg University Hospital, Aalborg

Rigshospitalet, Copenhagen

Dansk Fertilitetsklinik, Frederiksberg

Hvidovre Hospital, Hvidovre

Dexeus Woman's Health, Barcelona

Instituto Valenciano de Infertilidad (IVI) - Bilbao, Leioa

GINEFIV - Clinica Belen Location, Madrid

Instituto Valenciano de Infertilidad (IVI) - Madrid, Madrid

Instituto Valenciano de Infertilidad (IVI) - Sevilla, Seville

Instituto Valenciano de Infertilidad (IVI) - Valencia, Valencia

Glasgow Royal Infirmary, Glasgow

Liverpool Women's Hospital, Liverpool

Guy's and St Thomas' NHS Trust, London

Kings College (Assisted Conception Unit), London

Sponsors
All Listed Sponsors
lead

Ferring Pharmaceuticals

INDUSTRY

NCT03564509 - 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. | Biotech Hunter | Biotech Hunter