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NCT04880590 Clinical Trial

Sex or no Sex: That is the Question.

Infertility, Female Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04880590
Other study ID # FSD-SEX-2021-05
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 4, 2021
Est. completion date February 2026

Study information
Verified date March 2024
Source Institut Universitari Dexeus
Contact Isabeth Gonzalez de Campagnolo, MD
Phone 0034932274700
Email isagon@dexeus.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 2500
Est. completion date February 2026
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Sex intercourse
A heterosexual sexual relationship

Locations
Country Name City State
Spain Hospital Universitario Quiron Dexeus Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Fundación Santiago Dexeus Font

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical pregnancy rate Clinical pregnancy rate measured by ultrasound with the presence of a positive fetal heartbeat 6-7 weeks after transfer
Secondary Miscarriage rate The loss of a pregnancy during the first 13 weeks of pregnancy Until 13 weeks after embryo transfer procedure
Secondary Live birth rate Number of live birth after embryo transfer Until 42 weeks after embryo transfer
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