Conditions: Luteal Hormone Supplementation in In-vitro Fertilization Embryo Transfer
Keywords: Infertility COL-1620 progesterone gel Fertilization in Vitro Embryo Transfer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 178
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: COL-1620 intervention 2: Gonadotropin-releasing hormone (GnRH) analogue intervention 3: Follicle-stimulating hormone (FSH) intervention 4: Human Chorionic Gonadotropin (hCG)
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using FSH containing preparation. intervention 4: Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using hCG preparation.

Protocol document: