Phase 3 Placebo Controlled Study of Nolasiban to Improve Pregnancy Rates in Women Undergoing IVF/ICSI
NCT ID: NCT03081208
Last Updated: 2019-12-23
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
810 participants
INTERVENTIONAL
2017-03-06
2019-02-19
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Nolasiban 900 mg
Nolasiban 900mg
Nolasiban dispersible tablets for single oral administration
Placebo
Placebo
Placebo dispersible tablets for single oral administration
Interventions
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Nolasiban 900mg
Nolasiban dispersible tablets for single oral administration
Placebo
Placebo dispersible tablets for 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 phase support with vaginal micronized progesterone.
* Single, fresh D3 or D5 embryo transfer
Exclusion Criteria
* More than 20 oocytes in the current controlled ovarian hyperstimulation (COH) cycle
* Serum P4 greater than 1.5 ng/mL on the day of hCG administration
18 Years
36 Years
FEMALE
No
Sponsors
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ObsEva SA
INDUSTRY
Responsible Party
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Principal Investigators
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ObsEva SA
Role: STUDY_DIRECTOR
Geneva
Locations
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Investigator ID 1001
Brussels, , Belgium
Investigator ID 1002
Brussels, , Belgium
Investigator ID 1003
Brussels, , Belgium
Investigator ID 1004
Brussels, , Belgium
Investigator ID 1107
Olomouc, , Czechia
Investigator ID 1101
Prague, , Czechia
Investigator ID 1102
Prague, , Czechia
Investigator ID 1103
Prague, , Czechia
Investigator ID 1104
Prague, , Czechia
Investigator ID 1108
Prague, , Czechia
Investigator ID 1109
Teplice, , Czechia
Investigator ID 1106
Zlín, , Czechia
Investigator ID 1204
Copenhagen, , Denmark
Investigator ID 1205
Herlev, , Denmark
Investigator ID 1202
Hvidovre, , Denmark
Investigator ID 1203
Skive, , Denmark
Investigator ID 1301
Tartu, , Estonia
Investigator ID 1303
Tartu, , Estonia
Investigator ID 1401
Helsinki, , Finland
Investigator ID 1402
Helsinki, , Finland
Investigator ID 1403
Oulu, , Finland
Investigator ID 1501
Heidelberg, , Germany
Investigator ID 1502
Lübeck, , Germany
Investigator ID 1504
Mainz, , Germany
Investigator ID 1503
Marburg, , Germany
Investigator ID 1601
Budapest, , Hungary
Investigator ID 1604
Budapest, , Hungary
Investigator ID 1603
Pécs, , Hungary
Investigator ID 1602
Tapolca, , Hungary
Investigator ID 1701
Bialystok, , Poland
Investigator ID 1703
Bialystok, , Poland
Investigator ID 1705
Bialystok, , Poland
Investigator ID 1702
Katowice, , Poland
Investigator ID 1704
Szczecin, , Poland
Investigator ID 1706
Warsaw, , Poland
Investigator ID 1801
Barakaldo, , Spain
Investigator ID 1805
Barcelona, , Spain
Investigator ID 1808
Barcelona, , Spain
Investigator ID 1809
Leioa, , Spain
Investigator ID 1804
Madrid, , Spain
Investigator ID 1807
Madrid, , Spain
Investigator ID 1811
Seville, , Spain
Investigator ID 1806
Valencia, , 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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16-OBE001-005
Identifier Type: -
Identifier Source: org_study_id