At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-label, Single-arm, Multicenter Phase III Trial to Evaluate the Efficacy and Safety of COL-1620 8% Vaginal Progesterone Gel for Luteal Phase Support in In-vitro Fertilization and Embryo Transfer (IVF/ET) Cycles in Japanese Women
In Brief
A Phase 3 clinical trial evaluating COL-1620, Gonadotropin-releasing hormone (GnRH) analogue, and 2 other interventions for Luteal Hormone Supplementation in In-vitro Fertilization and Embryo Transfer. Completed, enrolled 178 participants across 5 sites.
Detailed Summary
The primary objective of this trial is to demonstrate the non-inferiority of the clinical pregnancy rate per embryo transfer to the historical standard value in in-vitro fertilization (IVF)/embryo transfer (ET) cycles in Japan (Japan Society of Obstetrics and Gynecology \[JSOG\] 2009 registry data: 24.3 percent \[%\]). The secondary objectives of this trial are to assess the biochemical pregnancy rate per ET, pharmacokinetics, and safety of COL-1620.
Study Details
Timeline
Interventions
The subjects will be administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8 percent \[%\] gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12.
Subjects will undergo conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation.
Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using FSH containing preparation.
Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using hCG preparation.