Sex or no Sex: That is the Question.

Sponsor
Fundación Santiago Dexeus Font (Other)
Overall Status
Recruiting
CT.gov ID
NCT04880590
Collaborator
(none)
2,500
1
21
119.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
2500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Sex or no Sex: That is the Question. Impact of Coital Sexual Intercourse on the Clinical Pregnancy Rate After Embryo Transfer.
Actual Study Start Date :
May 4, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Clinical pregnancy rate [6-7 weeks after transfer]

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

Secondary Outcome Measures

  1. Miscarriage rate [Until 13 weeks after embryo transfer procedure]

    The loss of a pregnancy during the first 13 weeks of pregnancy

  2. Live birth rate [Until 42 weeks after embryo transfer]

    Number of live birth after embryo transfer

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario Quiron Dexeus Barcelona Spain 08028

Sponsors and Collaborators

  • Fundación Santiago Dexeus Font

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Fundación Santiago Dexeus Font
ClinicalTrials.gov Identifier:
NCT04880590
Other Study ID Numbers:
  • FSD-SEX-2021-05
First Posted:
May 11, 2021
Last Update Posted:
May 12, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2021