NCT04880590

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 5, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

4.5 years

First QC Date

May 5, 2021

Last Update Submit

March 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    Clinical pregnancy rate measured by ultrasound with the presence of a positive fetal heartbeat

    6-7 weeks after transfer

Secondary Outcomes (2)

  • Miscarriage rate

    Until 13 weeks after embryo transfer procedure

  • Live birth rate

    Until 42 weeks after embryo transfer

Study Arms (2)

Sex Intercourse

women with a heterosexual sexual relationship after embryo transfer

Other: Sex intercourse

Non sex intercourse

women without a heterosexual sexual relationship after embryo transfer

Interventions

A heterosexual sexual relationship

Sex Intercourse

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Quiron Dexeus

Barcelona, 08028, Spain

RECRUITING

Related 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.

    PMID: 29489026BACKGROUND
  • 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: 9806568BACKGROUND
  • 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: 9740459BACKGROUND
  • 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: 23480148BACKGROUND
  • 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: 32756956BACKGROUND
  • 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: 23386877BACKGROUND
  • 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: 11098040BACKGROUND

Related Links

MeSH Terms

Conditions

Infertility, FemaleCoitus

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertilitySexual BehaviorBehavior

Central Study Contacts

Isabeth Gonzalez de Campagnolo, MD

CONTACT

Ignacio Rodríguez, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 11, 2021

Study Start

May 4, 2021

Primary Completion

November 1, 2025

Study Completion

February 1, 2026

Last Updated

March 11, 2025

Record last verified: 2025-03

Locations