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

December 14, 2023 updated by: The First Hospital of Jilin University

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jilin
      • Changchun, Jilin, China, 130000
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The recruiters are all couples seeking to conceive from the Reproductive Center of a university affiliated hospita. All couples are healthy. They have normal sexual intercourse without contraception, and not pregnant for more than six months.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Will hospital ovulation monitoring increase stress levels in couples?
Time Frame: A year
The questionnaires used were the Perceived Stress Scale (PSS). The instrument uses a 5-point Likert scale rating from "0 = never" to "4=very often"for 14 items. Scores can range from 0 to 56, with higher score indicates greater psychological stress. Compare whether there are differences between hospital ovulation monitoring and home ovulation monitoring.
A year
Will hospital ovulation monitoring increase anxiety and depression in couples?
Time Frame: A year
The questionnaires used were the Hospital Anxiety and Depression Scale (HADS). Each domain has seven items with score ranges of 0 to 3, and total scores of 0 to 21. Higher scores indicate higher levels of anxiety and depression. Compare whether there are differences between hospital ovulation monitoring and home ovulation monitoring.
A year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The impact of two sets of ovulation monitoring methods on sexual function
Time Frame: 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
A year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-HS-115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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