The Impact of Vaginal Intercourse on Pregnancy Rates After Frozen Embryo Transfer

University of South Florida

Status: Unknown

Conditions: IVF; Infertility; Pregnancy Related

Treatments: Behavioral: Vaginal unprotected intercourse

Study type: Interventional

Funder types: Other

Identifiers

NCT03974295

Pro00040515

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 400 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• female fertility patients having frozen embryo transfer
• programmed hormone replacement (Oral Estrace, Vivelle dot (patch), intravenous Estradiol) with and without gonadotrophin releasing hormone analogue pretreatment and some form of parenteral progesterone supplementation (daily or every 3 days intramuscular Progesterone) for luteal support

Exclusion criteria

• unable to provide informed consent
• not undergoing programmed hormone replacement for frozen embryo transfer (natural cycle frozen embryo transfer)
• undergoing fresh embryo transfer
• not able to engage in heterosexual intercourse (same sex couple, partner with severe sexual dysfunction)
• cannot undergo unprotected vaginal intercourse (infected with hepatitis B, C, or human immunodeficiency virus).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

400 participants in 2 patient groups

Intercourse Group

Experimental group

Description:

unlimited unprotected vaginal intercourse starting 24 hours after the frozen embryo transfer

Treatment:

Behavioral: Vaginal unprotected intercourse

Pelvic Rest Group

No Intervention group

Description:

pelvic rest after frozen embryo transfer until positive pregnancy test