Ovo Clinic
Endometrin is a progesterone supplement prescribed during in vitro fertilization (IVF) for preparation for embryo transfer. The usual dose of Endometrin is 100 mg two to three times per day in the form of an effervescent tablet to be inserted vaginally. The purpose of this research project is to evaluate the dose response of the Endometrin when determined based on the blood level of progesterone on the day of the FET. According to the literature, a predefined level of progesterone in the blood should be reached in order to have favorable conditions for pregnancy. The hypothesis being that a woman with low progesterone levels would benefit from a dose of Endometrin of 600 mg (200 mg 3x/day) to decrease the risk of miscarriage and improve the chances of pregnancy. Women with adequate progesterone levels according to the literature, would continue with the standard dose of progesterone prescribed at clinique ovo which is 300 mg (100 mg 3x/day). PIBF (Progesterone Induced Blocking Factor) levels, a protein found in the blood that could also predict pregnancy outcomes in women using IVF will also be looked at.
Fertility Issues
Embryo Implantation
Frozen Embryo Transfer
Progesterone Effervescent Vaginal Tablet
Phase 2
Study Type : | Interventional |
Estimated Enrollment : | 150 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | Rescue Progesterone Supplementation in Patients With Low Progesterone on the Day of Embryo Transfer for Artificial Endometrial Preparation Cycles: a Non-inferiority Study |
Actual Study Start Date : | December 1, 2022 |
Estimated Primary Completion Date : | September 30, 2025 |
Estimated Study Completion Date : | June 30, 2026 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Endometrin 100 mg three times per day (TID) Women with progesterone levels ≥ 8.8 ng/ml during frozen embryo transfer cycle will take Endometrin 100 mg TID until 10th week of pregnancy |
Drug: Progesterone Effervescent Vaginal Tablet |
Active Comparator: Endometrin 200 mg three times per day (TID) Women with progesterone levels < 8.8 ng/ml during frozen embryo transfer cycle will take Endometrin 200 mg TID until 10th week of pregnancy |
Drug: Progesterone Effervescent Vaginal Tablet |
Ages Eligible for Study: | 18 Years to 42 Years |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Ovo Clinic
Montreal, Quebec, Canada, H4P 2S4