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

Not Applicable

• Conditions: IVF; Infertility; Pregnancy Related
• Interventions: Behavioral: Vaginal unprotected intercourse

• Registration Number: NCT03974295
• Lead Sponsor: University of South Florida

Brief Summary

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).

Detailed 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).

Study Timeline

• Status Verified: 2019-05
• Study First Submitted: 2019-05-20
• Study First Submitted QC: 2019-06-03
• Last Update Submitted: 2019-06-03
• Study First Posted: 2019-06-04
• Last Update Posted: 2019-06-04
• Study Start: 2019-07-01
• Primary Completion: 2021-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 400

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intercourse Group	Vaginal unprotected intercourse	unlimited unprotected vaginal intercourse starting 24 hours after the frozen embryo transfer

Primary Outcome Measures

Name	Time	Method
Pregnancy rates	up to 2 years	A serum quantitative pregnancy test will be performed 10-14 days following the frozen embryo transfer per clinic protocol. Positive pregnancy test is defined a serum quantitative beta hCG \> 5 mU/mL.

Secondary Outcome Measures

Name	Time	Method
Implantation rates	up to 2 years	Implantation rate will be defined as number of gestational sacs observed at echographic screening at 6 weeks of pregnancy divided by the number of embryos transferred.
Clinical pregnancy rate	up to 2 years	Ongoing clinical pregnancy rate is defined as presence of a fetal heartbeat at 6-7 weeks of pregnancy.
Biochemical pregnancy rate	up to 2 years	Biochemical pregnancy rate is defined as positive pregnancy test or elevated β-hCG level which does not result in implantation.
Miscarriage rate	up to 2 years	Miscarriage rate is defined as a pregnancy loss is the loss of a fetus that occurs before 20 weeks of gestation.
Live birth rate	up to 2 years	Live birth rate is defined as number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers.