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

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.

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Key information

Conditions

Fertility Issues Anxiety Disorders Behavior Behavioral Symptoms Coitus Depression Genital Diseases Infertility Mental Disorders Sexual Behavior Stress, Psychological Urogenital Diseases

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the first hospital of Jilin University

Changchun, Jilin, 130000, China

About this study

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）.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.
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.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Nov 13, 2023
Registry last updated: Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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