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

NCT ID: NCT06127875

Last Updated: 2025-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

311 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-11-09

Brief Summary

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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

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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).

Conditions

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Fertility Issues Stress, Psychological

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Home Ovulation Monitoring Group

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

No interventions assigned to this group

Hospital Ovulation Monitoring Group

timed intercourse by ultrasound ovulation monitoring

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Hospital of Jilin University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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yang yu

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

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the first hospital of Jilin University

Changchun, Jilin, China

Site Status

Countries

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China

References

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Zegers-Hochschild F, Adamson GD, Dyer S, Racowsky C, de Mouzon J, Sokol R, Rienzi L, Sunde A, Schmidt L, Cooke ID, Simpson JL, van der Poel S. The International Glossary on Infertility and Fertility Care, 2017. Fertil Steril. 2017 Sep;108(3):393-406. doi: 10.1016/j.fertnstert.2017.06.005. Epub 2017 Jul 29.

Reference Type BACKGROUND
PMID: 28760517 (View on PubMed)

Behre HM, Kuhlage J, Gassner C, Sonntag B, Schem C, Schneider HP, Nieschlag E. Prediction of ovulation by urinary hormone measurements with the home use ClearPlan Fertility Monitor: comparison with transvaginal ultrasound scans and serum hormone measurements. Hum Reprod. 2000 Dec;15(12):2478-82. doi: 10.1093/humrep/15.12.2478.

Reference Type BACKGROUND
PMID: 11098014 (View on PubMed)

Tiplady S, Jones G, Campbell M, Johnson S, Ledger W. Home ovulation tests and stress in women trying to conceive: a randomized controlled trial. Hum Reprod. 2013 Jan;28(1):138-51. doi: 10.1093/humrep/des372. Epub 2012 Oct 18.

Reference Type BACKGROUND
PMID: 23081872 (View on PubMed)

Weddell S, Jones GL, Duffy S, Hogg C, Johnson S, Ledger W. Home ovulation test use and stress during subfertility evaluation: Subarm of a randomized controlled trial. Womens Health (Lond). 2019 Jan-Dec;15:1745506519838363. doi: 10.1177/1745506519838363.

Reference Type BACKGROUND
PMID: 30924413 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36272105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33935968 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37709293 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26074135 (View on PubMed)

Xi Q, Kong Q, Lv X, Dai R, Yu Y. Impact of ejaculation frequency on semen parameters and DNA fragmentation: a cross-sectional study. Reprod Biol Endocrinol. 2025 Jul 16;23(1):100. doi: 10.1186/s12958-025-01439-3.

Reference Type DERIVED
PMID: 40671092 (View on PubMed)

Other Identifiers

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2023-HS-115

Identifier Type: -

Identifier Source: org_study_id

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