Study of Nolasiban to Increase Pregnancy Rates in Women Undergoing IVF
NCT ID: NCT03758885
Last Updated: 2021-09-09
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
PHASE3
820 participants
INTERVENTIONAL
2019-01-10
2020-11-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nolasiban 900 mg
Nolasiban dispersible tablets for single oral administration
Nolasiban
Nolasiban single oral administration
Placebo
Placebo dispersible tablets for single oral administration
Placebo
Placebo single oral administration
Interventions
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Nolasiban
Nolasiban single oral administration
Placebo
Placebo single oral administration
Eligibility Criteria
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Inclusion Criteria
* Follow a gonadotropin releasing hormone (GnRH) antagonist protocol, single injection of human chorionic gonadotropin (hCG) for triggering final follicular maturation and luteal support with vaginal micronized progesterone.
* Single fresh D5 embryo transfer
Exclusion Criteria
* Donor egg in the current transfer
* More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle
* Serum P4 greater than 1.5 ng/mL prior to hCG administration
18 Years
37 Years
FEMALE
No
Sponsors
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ObsEva SA
INDUSTRY
Responsible Party
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Locations
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Site 1001
Brussels, , Belgium
Site 1002
Brussels, , Belgium
Site 1003
Brussels, , Belgium
Site 1004
Brussels, , Belgium
Site 1404
Burnaby, , Canada
Site 1401
Montreal, , Canada
Site 1402
Toronto, , Canada
Site 1403
Toronto, , Canada
Site 1107
Olomouc, , Czechia
Site 1101
Prague, , Czechia
Site 1102
Prague, , Czechia
Site 1103
Prague, , Czechia
Site 1104
Prague, , Czechia
Site 1105
Prague, , Czechia
Site 1108
Prague, , Czechia
Site 1110
Prague, , Czechia
Site 1109
Teplice, , Czechia
Site 1106
Zlín, , Czechia
Site 1204
Copenhagen, , Denmark
Site 1205
Herlev, , Denmark
Site 1202
Hvidovre, , Denmark
Site 1203
Skive, , Denmark
Site 1302
Tallinn, , Estonia
Site 1301
Tartu, , Estonia
Site 1303
Tartu, , Estonia
Site 1504
Berlin, , Germany
Site 1506
Berlin, , Germany
Site 1505
Bielefeld, , Germany
Site 1501
Heidelberg, , Germany
Site 1502
Lübeck, , Germany
Site 1503
Marburg, , Germany
Site 1601
Budapest, , Hungary
Site 1603
Budapest, , Hungary
Site 1602
Tapolca, , Hungary
Site 1703
Bialystok, , Poland
Site 1705
Bialystok, , Poland
Site 1702
Katowice, , Poland
Site 1701
Krakow, , Poland
Site 1704
Szczecin, , Poland
Site 1706
Warsaw, , Poland
Site 1901
Moscow, , Russia
Site 1905
Moscow, , Russia
Site 1904
Samara, , Russia
Site 1902
Yekaterinburg, , Russia
Site 1805
Barcelona, , Spain
Site 1808
Barcelona, , Spain
Site 1809
Leioa, , Spain
Site 1804
Madrid, , Spain
Site 1807
Madrid, , Spain
Site 1811
Seville, , Spain
Countries
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References
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Griesinger G, Blockeel C, Pierzynski P, Tournaye H, Visnova H, Humberstone A, Terrill P, Pohl O, Garner E, Donnez J, Loumaye E. Effect of the oxytocin receptor antagonist nolasiban on pregnancy rates in women undergoing embryo transfer following IVF: analysis of three randomised clinical trials. Hum Reprod. 2021 Mar 18;36(4):1007-1020. doi: 10.1093/humrep/deaa369.
Other Identifiers
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18-OBE001-010
Identifier Type: -
Identifier Source: org_study_id
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