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

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06127875
• Other study ID #: 2023-HS-115
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: November 2024

Study information

• Verified date: October 2023
• Source: The First Hospital of Jilin University
• Contact: yang yu, doctorate
• Phone: +86 13844000361
• Email: yuyang0351[@]jlu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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）.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Issues
• Infertility
• Stress, Psychological

Locations

Country	Name	City	State
China	the first hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

References & Publications (8)

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. — View Citation

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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Will hospital ovulation monitoring increase stress levels in couples?	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
Primary	Will hospital ovulation monitoring increase anxiety and depression in couples?	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	The impact of two sets of ovulation monitoring methods on sexual function	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