Clinical trial NCT06127875: Effects of Trying to Conceive Using an Home- or Hospital-based Ovulation Monitoring on Stress
Official title: Effects of Trying to Conceive Using an Home- or Hospital-based Ovulation Monitoring on Stress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fertility Issues
Stress, Psychological
Keywords: Psychological stress
Ovulation Monitoring
anxiety
depression
Sexual intercourse
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 311
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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）.

Eligibility criteria: 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

Primary outcomes:
measure: Will hospital ovulation monitoring increase stress levels in couples?
timeFrame: A year
measure: Will hospital ovulation monitoring increase anxiety and depression in couples?
timeFrame: A year
Secondary outcomes:
measure: The impact of two sets of ovulation monitoring methods on sexual function
timeFrame: A year
Other outcomes:
Locations:
city: Changchun
country: China
facility: the first hospital of Jilin University
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: yang yu
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Martins MV, Fernandes J, Pedro J, Barros A, Xavier P, Schmidt L, Costa ME. Effects of trying to conceive using an every-other-day strategy versus fertile window monitoring on stress: a 12-month randomized controlled trial. Hum Reprod. 2022 Nov 24;37(12):2845-2855. doi: 10.1093/humrep/deac228.
citation: Ahn SH, Lee I, Cho S, Kim HI, Baek HW, Lee JH, Park YJ, Kim H, Yun BH, Seo SK, Park JH, Choi YS, Lee BS. Predictive Factors of Conception and the Cumulative Pregnancy Rate in Subfertile Couples Undergoing Timed Intercourse With Ultrasound. Front Endocrinol (Lausanne). 2021 Apr 15;12:650883. doi: 10.3389/fendo.2021.650883. eCollection 2021.
citation: Gibbons T, Reavey J, Georgiou EX, Becker CM. Timed intercourse for couples trying to conceive. Cochrane Database Syst Rev. 2023 Sep 15;9(9):CD011345. doi: 10.1002/14651858.CD011345.pub3.
citation: Song SH, Kim DS, Yoon TK, Hong JY, Shim SH. Sexual function and stress level of male partners of infertile couples during the fertile period. BJU Int. 2016 Jan;117(1):173-6. doi: 10.1111/bju.13201. Epub 2015 Jul 14.