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

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Impact of Vaginal Intercourse on Pregnancy Rates After Frozen Embryo Transfer; A Single Blinded Randomized Trial.

Conditions
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IVF, Infertility, Pregnancy Related

Intervention / Treatment
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* Behavioral: Vaginal unprotected intercourse


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intercourse Group<br>unlimited unprotected vaginal intercourse starting 24 hours after the frozen embryo transfer | Behavioral: Vaginal unprotected intercourse<br>* Patients will allowed to engage in vaginal unprotected intercourse as many times as desired after 24 hours of pelvic rest after a frozen embryo transfer.<br>|
| No Intervention: Pelvic Rest Group<br>pelvic rest after frozen embryo transfer until positive pregnancy test | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rates | 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. | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implantation rates | 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. | up to 2 years | 
| Clinical pregnancy rate | Ongoing clinical pregnancy rate is defined as presence of a fetal heartbeat at 6-7 weeks of pregnancy. | up to 2 years | 
| Biochemical pregnancy rate | Biochemical pregnancy rate is defined as positive pregnancy test or elevated β-hCG level which does not result in implantation. | up to 2 years | 
| Miscarriage rate | Miscarriage rate is defined as a pregnancy loss is the loss of a fetus that occurs before 20 weeks of gestation. | up to 2 years | 
| Live birth rate | Live birth rate is defined as number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers. | up to 2 years |