Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 2
NCT ID: NCT01956123
Last Updated: 2023-09-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
513 participants
INTERVENTIONAL
2014-03-26
2017-01-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A
Follitropin Delta (FE 999049) (COS cycle 2)
Follitropin Delta (FE 999049)
B
Follitropin Alfa (GONAL-F) (COS cycle 2)
Follitropin Alfa (GONAL-F)
C
Follitropin Delta (FE 999049) (COS cycle 3)
Follitropin Delta (FE 999049)
D
Follitropin Alfa (GONAL-F) (COS cycle 3)
Follitropin Alfa (GONAL-F)
Interventions
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Follitropin Delta (FE 999049)
Follitropin Alfa (GONAL-F)
Eligibility Criteria
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Inclusion Criteria
* Participation in the pivotal efficacy trial (trial 000004/ESTHER-1)
* Anti-FSH antibody results from baseline and at least one post-dosing assessment in the previous cycle(s) available.
* Having undergone the oocyte retrieval procedure, or having had cycle cancellation prior to oocyte retrieval due to poor ovarian response or excessive ovarian response, in the previous cycle(s).
* Failure to achieve ongoing pregnancy in the previous cycle(s).
Exclusion Criteria
* Having undergone any stimulation with gonadotropins since the end-of-trial / end-of-cycle visit in the previous cycle
* One or more follicles ≥10 mm observed on the transvaginal ultrasound prior to start of dosing on stimulation day 1
* Severe OHSS in a previous cycle.
* Any clinically relevant change to any of the eligibility criteria in the previous cycle(s).
* Clinically relevant medical history since the previous cycle which precludes gonadotropin stimulation or is associated with a reduced chance of pregnancy.
18 Years
40 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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UZ Brussel (there may be other sites in this country)
Brussels, , Belgium
Fertilitat and PUC-RS (there may be other sites in this country)
Porto Alegre, , Brazil
Pacific Centre for Reproductive Medicine
Burnaby, British Columbia, Canada
Olive Fertility Centre
Vancouver, British Columbia, Canada
Ottawa Fertility Centre
Ottawa, Ontario, Canada
IVF CUBE SE (there may be other sites in this country)
Prague, , Czechia
Rigshospitalet Fertilitetsklinikken (there may be other sites in this country)
Copenhagen, , Denmark
Department of Endocrine Gynaecology and Reproductive Medicine, Hôpital Jeanne de Flandre (there may be other sites in this country)
Lille, , France
Centro Natalità San Raffaele (there may be other sites in this country)
Milan, , Italy
The nOvum Clinic (there may be other sites in this country)
Warsaw, , Poland
IVF & Reproductive Genetics Center (there may be other sites in this country)
Moscow, , Russia
IVI Sevilla (there may be other sites in this country)
Seville, , Spain
Glasgow Centre for Reproductive Medicine Ltd. (there may be other sites in this country)
Glasgow, , United Kingdom
Countries
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References
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Havelock J, Aaris Henningsen AK, Mannaerts B, Arce JC; ESTHER-1 and ESTHER-2 Trial Groups. Pregnancy and neonatal outcomes in fresh and frozen cycles using blastocysts derived from ovarian stimulation with follitropin delta. J Assist Reprod Genet. 2021 Oct;38(10):2651-2661. doi: 10.1007/s10815-021-02271-5. Epub 2021 Jul 13.
Fernandez-Sanchez M, Fatemi H, Garcia-Velasco JA, Heiser PW, Daftary GS, Mannaerts B. Incidence and severity of ovarian hyperstimulation syndrome (OHSS) in high responders after gonadotropin-releasing hormone (GnRH) agonist trigger in "freeze-all" approach. Gynecol Endocrinol. 2023 Dec;39(1):2205952. doi: 10.1080/09513590.2023.2205952.
Nelson SM, Larsson P, Mannaerts BMJL, Nyboe Andersen A, Fauser BCJM. Anti-Mullerian hormone variability and its implications for the number of oocytes retrieved following individualized dosing with follitropin delta. Clin Endocrinol (Oxf). 2019 May;90(5):719-726. doi: 10.1111/cen.13956. Epub 2019 Mar 18.
Other Identifiers
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2013-001616-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1147-6922
Identifier Type: OTHER
Identifier Source: secondary_id
000071
Identifier Type: -
Identifier Source: org_study_id
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