At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 800 enrolled
Drug / intervention
Progesterone +1 moredrug
Likely dose
Progesterone 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Tolerability of Subcutaneous Progesterone (IBSA) Versus Vaginal Progesterone for Luteal Phase Support in Patients Undergoing In Vitro Fertilization (IVF)
In Brief
A Phase 3 clinical trial evaluating Progesterone for In Vitro Fertilization. Completed, enrolled 800 participants across 8 sites.
Detailed Summary
Prospective, open, randomized, parallel, multicenter, two-arm trial to evaluate the efficacy and tolerability of a new progesterone formulation to be used for luteal support in IVF (Progesterone-IBSA) administered subcutaneously at a daily dose of 25 mg versus Progesterone tablets administered intravaginally at 100 mg twice daily for a total dose of 200 mg.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIn Vitro Fertilization
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2008
First PostedJan 2009
Primary CompletionJul 2011
Study CompletionFeb 2012
TodayJul 2026
First PostedJan 23, 2009
Enrollment StartDec 1, 2008
Primary CompletionJul 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.4 years ago
Interventions
Progesteronedrug
25 mg, once a day, SC
Progesteronedrug
100 mg, twice a day, vaginally