IVF Failure and Pregnancy Loss on Couples' Psychological Stress

NCT ID: NCT06385444

Last Updated: 2024-04-26

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this observational study is to learn about The purpose of this study was to compare the psychological differences between couples after IVF transplant failure and IVF pregnancy loss, including the differences in anxiety, depression, stress and post-traumatic stress between women and their spouses. The main question it aims to answer is:

What are the psychological effects of IVF implantation failure and IVF pregnancy loss on women and the psychological differences between couples? Participants already taking IVF as part of their regular medical care will answer online survey questions about their joint pain for 1 years.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The goal of this observational study is to learn about The purpose of this study was to compare the psychological differences between couples after IVF transplant failure and IVF pregnancy loss, including the differences in anxiety, depression, and stress between women and their spouses. Some couples will experience symptoms of post-traumatic stress reaction (PTS), and there are also large differences. The differences between couples discussed in this study also pay attention to male spouses. Guidance and education for male spouses can reduce cognitive differences between couples and generate understanding and empathy, which is conducive to promoting the stability of family relations and intimate relationships.

1. Does the number of IVF implant failures have a differential effect on anxiety, depression and fertility stress in women and their partners?
2. Does pregnancy loss after IVF transplantation have a differential effect on anxiety, depression, fertility stress and post-traumatic stress responses in women and their partners?

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fertilization in Vitro Pregnancy Loss Psychological Stress Post-traumatic Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

The female spouse of a couple

Women in couples with IVF pregnancy loss and IVF failure

No interventions assigned to this group

The male spouse of a couple

Men in couples with IVF pregnancy loss and IVF failure

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Couples who have undergone IVF at our center and have completed at least 1 embryo transfer.
2. Female age 20-45 years, male age 22-45 years.

Exclusion Criteria

1. Couples with contraindications to pregnancy.
2. Couples who undergo donor IVF.
3. Infertility women caused by organic lesions.
4. Couples with previous mental disorders.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The First Hospital of Jilin University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Qi Xi, doctorate

Role: PRINCIPAL_INVESTIGATOR

The First Hospital of Jilin University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

the first hospital of Jilin University

Changchun, Jilin, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Qi Xi, doctorate

Role: CONTACT

15804303801

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Qi Xi, doctorate

Role: primary

15804303801

References

Explore related publications, articles, or registry entries linked to this study.

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. Hum Reprod. 2017 Sep 1;32(9):1786-1801. doi: 10.1093/humrep/dex234.

Reference Type RESULT
PMID: 29117321 (View on PubMed)

Vander Borght M, Wyns C. Fertility and infertility: Definition and epidemiology. Clin Biochem. 2018 Dec;62:2-10. doi: 10.1016/j.clinbiochem.2018.03.012. Epub 2018 Mar 16.

Reference Type RESULT
PMID: 29555319 (View on PubMed)

Agarwal A, Mulgund A, Hamada A, Chyatte MR. A unique view on male infertility around the globe. Reprod Biol Endocrinol. 2015 Apr 26;13:37. doi: 10.1186/s12958-015-0032-1.

Reference Type RESULT
PMID: 25928197 (View on PubMed)

Chachamovich JR, Chachamovich E, Ezer H, Fleck MP, Knauth D, Passos EP. Investigating quality of life and health-related quality of life in infertility: a systematic review. J Psychosom Obstet Gynaecol. 2010 Jun;31(2):101-10. doi: 10.3109/0167482X.2010.481337.

Reference Type RESULT
PMID: 20443659 (View on PubMed)

Cates W, Farley TM, Rowe PJ. Worldwide patterns of infertility: is Africa different? Lancet. 1985 Sep 14;2(8455):596-8. doi: 10.1016/s0140-6736(85)90594-x.

Reference Type RESULT
PMID: 2863605 (View on PubMed)

Khademi A, Alleyassin A, Amini M, Ghaemi M. Evaluation of sexual dysfunction prevalence in infertile couples. J Sex Med. 2008 Jun;5(6):1402-10. doi: 10.1111/j.1743-6109.2007.00687.x. Epub 2007 Dec 14.

Reference Type RESULT
PMID: 18086173 (View on PubMed)

Wischmann T. Implications of psychosocial support in infertility--a critical appraisal. J Psychosom Obstet Gynaecol. 2008 Jun;29(2):83-90. doi: 10.1080/01674820701817870.

Reference Type RESULT
PMID: 18484439 (View on PubMed)

Murphy FA. The experience of early miscarriage from a male perspective. J Clin Nurs. 1998 Jul;7(4):325-32. doi: 10.1046/j.1365-2702.1998.00153.x.

Reference Type RESULT
PMID: 9830973 (View on PubMed)

Facchinetti F, Matteo ML, Artini GP, Volpe A, Genazzani AR. An increased vulnerability to stress is associated with a poor outcome of in vitro fertilization-embryo transfer treatment. Fertil Steril. 1997 Feb;67(2):309-14. doi: 10.1016/S0015-0282(97)81916-4.

Reference Type RESULT
PMID: 9022608 (View on PubMed)

Cimadomo D, Craciunas L, Vermeulen N, Vomstein K, Toth B. Definition, diagnostic and therapeutic options in recurrent implantation failure: an international survey of clinicians and embryologists. Hum Reprod. 2021 Jan 25;36(2):305-317. doi: 10.1093/humrep/deaa317.

Reference Type RESULT
PMID: 33313697 (View on PubMed)

ESHRE Working Group on Recurrent Implantation Failure; Cimadomo D, de Los Santos MJ, Griesinger G, Lainas G, Le Clef N, McLernon DJ, Montjean D, Toth B, Vermeulen N, Macklon N. ESHRE good practice recommendations on recurrent implantation failure. Hum Reprod Open. 2023 Jun 15;2023(3):hoad023. doi: 10.1093/hropen/hoad023. eCollection 2023.

Reference Type RESULT
PMID: 37332387 (View on PubMed)

ESHRE Guideline Group on RPL; Bender Atik R, Christiansen OB, Elson J, Kolte AM, Lewis S, Middeldorp S, Mcheik S, Peramo B, Quenby S, Nielsen HS, van der Hoorn ML, Vermeulen N, Goddijn M. ESHRE guideline: recurrent pregnancy loss: an update in 2022. Hum Reprod Open. 2023 Mar 2;2023(1):hoad002. doi: 10.1093/hropen/hoad002. eCollection 2023.

Reference Type RESULT
PMID: 36873081 (View on PubMed)

Cumming GP, Klein S, Bolsover D, Lee AJ, Alexander DA, Maclean M, Jurgens JD. The emotional burden of miscarriage for women and their partners: trajectories of anxiety and depression over 13 months. BJOG. 2007 Sep;114(9):1138-45. doi: 10.1111/j.1471-0528.2007.01452.x. Epub 2007 Jul 26.

Reference Type RESULT
PMID: 17655731 (View on PubMed)

Farren J, Jalmbrant M, Falconieri N, Mitchell-Jones N, Bobdiwala S, Al-Memar M, Tapp S, Van Calster B, Wynants L, Timmerman D, Bourne T. Differences in post-traumatic stress, anxiety and depression following miscarriage or ectopic pregnancy between women and their partners: multicenter prospective cohort study. Ultrasound Obstet Gynecol. 2021 Jan;57(1):141-148. doi: 10.1002/uog.23147.

Reference Type RESULT
PMID: 33032364 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-HS-020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.