Effects of Trying to Conceive Using an Home- or Hospital-based Ovulation Monitoring on Stress

Sponsor
The First Hospital of Jilin University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06127875
Collaborator
(none)
260
12

Study Details

Study Description

Brief Summary

The goal of this observational study is to compare the difference of stress level and anxiety and depression between couples under home ovulation monitoring and hospital ultrasound monitoring.And whether it has a negative effect on the couple's sexual behavior.The participants were all healthy couples with fertility requirements from the reproductive

Center of the First Hospital of Jilin University.The main questions it aims to answer are:
  • [question1] : Does ultrasound monitoring of ovulation increase stress levels and anxiety and depression in couples trying to conceive?

  • [question2] : Does ovulation monitoring affect couples' sexual function and satisfaction? Participants will be asked to fill out questionnaires three times over four menstrual cycles.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The goal of this observational study is to compare the difference of stress level and anxiety and depression between couples under home ovulation monitoring and hospital ultrasound monitoring.And whether it has a negative effect on the couple's sexual behavior.The participants were all healthy couples with fertility requirements from the reproductive Center of the First Hospital of Jilin University.

    Each couple needs to complete three questionnaires, one after informed consent, the second after two menstrual cycles, and the third after four menstrual cycles. If the woman becomes pregnant within 4 cycles, the investigation will be stopped.

    The study was divided into two groups,home ovulation monitoring group and hospital ovulation monitoring group.The questionnaires used were the Perceived Stress Scale (PSS) , the Hospital Anxiety and Depression Scale (HADS) ,Sexual functioning was assessed with the Female Sexual Function Index (FSFI) ,the International Index of Erectile Function (IIEF) and premature ejaculation diagnostic tool(PEDT).

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    260 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effects of Trying to Conceive Using an Home- or Hospital-based Ovulation Monitoring on Stress
    Anticipated Study Start Date :
    Nov 1, 2023
    Anticipated Primary Completion Date :
    Nov 1, 2024
    Anticipated Study Completion Date :
    Nov 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Home Ovulation Monitoring Group

    timed intercourse by predicting the ovulation period or using ovulation test strips

    Hospital Ovulation Monitoring Group

    timed intercourse by ultrasound ovulation monitoring

    Outcome Measures

    Primary Outcome Measures

    1. Will hospital ovulation monitoring increase stress levels in couples? [A year]

      The questionnaires used were the Perceived Stress Scale (PSS) (Cohen et al, 1983). A higher score indicates greater psychological stress. Compare whether there are differences between hospital ovulation monitoring and home ovulation monitoring.

    2. Will hospital ovulation monitoring increase anxiety and depression in couples? [A year]

      The questionnaires used were the Hospital Anxiety and Depression Scale (HADS). Higher scores indicate higher levels of anxiety and depression. Compare whether there are differences between hospital ovulation monitoring and home ovulation monitoring.

    Secondary Outcome Measures

    1. The impact of two sets of ovulation monitoring methods on sexual function [A year]

      Sexual functioning was assessed with the Female Sexual Function Index (FSFI) for female and the International Index of Erectile Function (IIEF) and premature ejaculation diagnostic tool(PEDT) for male. Compare whether there are differences between hospital ovulation monitoring and home ovulation monitoring

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Normal sexual activity, no contraception for more than six months, and no ovulation monitoring in any way before Preparing for ovulation monitoring
    Exclusion Criteria:
    • Couples with contraindications to pregnancy The man was diagnosed with severe oligozoospermia and azoospermia

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • The First Hospital of Jilin University

    Investigators

    • Principal Investigator: yang yu, The First Hospital of Jilin University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    The First Hospital of Jilin University
    ClinicalTrials.gov Identifier:
    NCT06127875
    Other Study ID Numbers:
    • 2023-HS-115
    First Posted:
    Nov 13, 2023
    Last Update Posted:
    Nov 18, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The First Hospital of Jilin University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 18, 2023