Infertility Clinical Trial
Official title:
The Impact of Vaginal Intercourse on Pregnancy Rates After Frozen Embryo Transfer; A Single Blinded Randomized Trial.
This study aims to evaluate whether allowing unprotected vaginal intercourse 24 hours after frozen embryo transfer will result in higher ongoing clinical pregnancy rates in comparison to having participants abstain from unprotected vaginal intercourse until pregnancy test (10-14 days after frozen embryo transfer).
Given the overwhelming evidence suggesting beneficial effect of seminal plasma on embryo
implantation, we sought to explore this benefits in in vitro fertilization treatments by
limiting the study cohort to those having frozen embryo transfer with programmed hormone
replacement for endometrial preparation and some form of parenteral progesterone
supplementation. This design will enable us to overcome the concerns and limitations of all
previous studies. In this study, patients will be randomized into two groups, group 1 will
have their frozen embryo transfer followed by current standard of care (no unprotected
vaginal intercourse until pregnancy test) and group 2 will have their frozen embryo transfer
followed by unlimited unprotected vaginal intercourse starting 24 hours after transfer. The
primary endpoint of the study will be ongoing clinical pregnancy
rates in the two groups while secondary endpoints will include implantation, positive
pregnancy, miscarriage and live birth rates. Overall, this study aims to investigate whether
the elimination of current universal pelvic rest protocol in patients undergoing frozen
embryo transfer will help optimize pregnancy outcomes.
This study aims to evaluate whether allowing unprotected vaginal intercourse 24 hours after
frozen embryo transfer will result in higher ongoing clinical pregnancy rates in comparison
to having participants abstain from unprotected vaginal intercourse until pregnancy test
(10-14 days after frozen embryo transfer).
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