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Recruiting NCT04880590

Sex or no Sex: That is the Question.

— Observational Infertility, Female Sexual Intercourse

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sex intercourse.
Who it may be relevant to
Registry conditions: Infertility, Female, Sexual Intercourse. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Other Sex intercourse
    A heterosexual sexual relationship

Primary outcome measures

  • Clinical pregnancy rate [Time frame: 6-7 weeks after transfer]
Secondary outcome measures (2)
  • Miscarriage rate [Time frame: Until 13 weeks after embryo transfer procedure]
  • Live birth rate [Time frame: Until 42 weeks after embryo transfer]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Hospital Universitario Quiron Dexeus — Barcelona

Publications

  • 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. PMID 29489026
  • 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. PMID 9806568
  • 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. PMID 9740459
  • 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. PMID 23480148
  • 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. PMID 32756956
  • 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. PMID 23386877
  • 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. PMID 11098040

Identifiers

NCT: NCT04880590 · FSD-SEX-2021-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗