Sex or no Sex: That is the Question.

Sex or no Sex: That is the Question. Impact of Coital Sexual Intercourse on the Clinical Pregnancy Rate After Embryo Transfer.

This study aims to evaluate the impact of sexual intercourse and orgasm in the 72 hrs following embryo transfer of blastocysts on the clinical pregnancy rate.

An impact on sexual activity and a decrease in the frequency of intercourse has been observed in infertile couples. In couples who undergo assisted reproductive technology (ART), sexual relations have an additional component that can condition them, such as the fear of influencing the outcome of the cycle.

The usual practice in ART cycles has evolved towards a preference for blastocyst-stage embryo transfer, both in fresh in vitro fertilization (IVF) cycles and in frozen embryo transfer (FET) cycles.

The investigators consider it important to elucidate whether coital intercourse after embryo transfer (ET) has an impact on the clinical pregnancy rate after the transfer of blastocyst-stage embryos.

Study Overview

• Status: Recruiting
• Conditions: Infertility, Female; Sexual Intercourse
• Intervention / Treatment: Other: Sex intercourse

Detailed Description

It is proposed to carry out an observational, prospective study, in which women with a heterosexual sexual relationship are included, who carry out an embryo transfer, in a FET cycle in the Dexeus Woman Reproduction Medicine Service and who agree to participate in the same.

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Ignacio Rodríguez, MSc; Phone Number: 0034932274700; Email: nacrod@dexeus.com
• Study Contact Backup: Name: Isabeth Gonzalez de Campagnolo, MD; Phone Number: 0034932274700; Email: isagon@dexeus.com

Study Locations

• Spain
  • Barcelona, Spain, 08028
    • Recruiting
    • Hospital Universitario Quiron Dexeus
    • Contact: Ignacio Rodríguez, MSc; Phone Number: 0034932274700; Email: nacrod@dexeus.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

-After detailed oral and written information on the nature of the study, patients who meet the inclusion criteria will give their written consent. According to this consent, patients agree to have their data used and analyzed for the present study.

Description

Inclusion Criteria:

• Women with a heterosexual sexual relationship
• That they carry out an embryo transfer, in a FET cycle

Exclusion Criteria:

• Exclusion criteria are not foreseen

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sex Intercourse; women with a heterosexual sexual relationship after embryo transfer	Other: Sex intercourse; A heterosexual sexual relationship
Non sex intercourse; women without a heterosexual sexual relationship after embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical pregnancy rate	Clinical pregnancy rate measured by ultrasound with the presence of a positive fetal heartbeat	6-7 weeks after transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Miscarriage rate	The loss of a pregnancy during the first 13 weeks of pregnancy	Until 13 weeks after embryo transfer procedure
Live birth rate	Number of live birth after embryo transfer	Until 42 weeks after embryo transfer

Collaborators and Investigators

• Sponsor: Fundación Santiago Dexeus Font

Publications and helpful links

General Publications

• Fanchin R, Righini C, Olivennes F, Taylor S, de Ziegler D, Frydman R. Uterine contractions at the time of embryo transfer alter pregnancy rates after in-vitro fertilization. Hum Reprod. 1998 Jul;13(7):1968-74. doi: 10.1093/humrep/13.7.1968.
• Ata B, Abou-Setta AM, Seyhan A, Buckett W. Application of seminal plasma to female genital tract prior to embryo transfer in assisted reproductive technology cycles (IVF, ICSI and frozen embryo transfer). Cochrane Database Syst Rev. 2018 Feb 28;2(2):CD011809. doi: 10.1002/14651858.CD011809.pub2.
• Fanchin R, Harmas A, Benaoudia F, Lundkvist U, Olivennes F, Frydman R. Microbial flora of the cervix assessed at the time of embryo transfer adversely affects in vitro fertilization outcome. Fertil Steril. 1998 Nov;70(5):866-70. doi: 10.1016/s0015-0282(98)00277-5.
• Robertson SA, Prins JR, Sharkey DJ, Moldenhauer LM. Seminal fluid and the generation of regulatory T cells for embryo implantation. Am J Reprod Immunol. 2013 Apr;69(4):315-30. doi: 10.1111/aji.12107.
• Stanford JB, Hansen JL, Willis SK, Hu N, Thomas A. Peri-implantation intercourse does not lower fecundability. Hum Reprod. 2020 Sep 1;35(9):2107-2112. doi: 10.1093/humrep/deaa156.
• Tao P, Coates R, Maycock B. The impact of infertility on sexuality: A literature review. Australas Med J. 2011;4(11):620-7. doi: 10.4066/AMJ.20111055. Epub 2011 Nov 30.
• Tremellen KP, Valbuena D, Landeras J, Ballesteros A, Martinez J, Mendoza S, Norman RJ, Robertson SA, Simon C. The effect of intercourse on pregnancy rates during assisted human reproduction. Hum Reprod. 2000 Dec;15(12):2653-8. doi: 10.1093/humrep/15.12.2653.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2021
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 5, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Infertility; Infertility, Female
• Other Study ID Numbers: FSD-SEX-2021-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No