IVF Failure and Pregnancy Loss on Couples' Psychological Stress

NCT06385444 | Not Yet Recruiting

• 1 other identifier: 2024-HS-020
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fertilization in Vitro; Pregnancy Loss; Psychological Stress; Post-traumatic Stress

Keywords

IVF failure; IVF pregnancy Loss; Psychological Stress; Post-traumatic Stress; Anxiety and depression

Outcome Measures

Primary Outcomes (4)

• As the number of failed IVF implants increases, does it increase the difference in anxiety and depression between couples?

  The questionnaires used were the Hospital Anxiety and Depression Scale (HADS). HADS was used to assess anxiety and depression symptoms. Each domain has seven items with score ranges of 0 to 3, and total scores of 0 to 21, with higher score indicates greater psychological stress. Compare whether there is a growing difference between couples as the number of IVF failures increases.

  1 year

• As the number of failed IVF implants increases, does it increase the difference in fertility stress between couples?

  The questionnaires used were the Fertility Problem Inventory (FPI). The FPI contains 46 items in 5 psychometric domains that measure social concern，sexual concern, relationship concern, the need for parenthood, and rejection of a childfree lifestyle. The instrument uses a 6-point Likert scale (1=strongly disagree;6=strongly agree). A high score in the FPI indicates a high level of perceived fertility-related stress. Compare whether there is a growing difference between couples as the number of IVF failures increases.

  1 year

• Does pregnancy loss after IVF transplantation have a differential effect on anxiety and depression between couples?

  The questionnaires used were the HADS. HADS was used to assess anxiety and depression symptoms. Each domain has seven items with score ranges of 0 to 3, and total scores of 0 to 21, with higher score indicates greater psychological stress. Compare whether there is a growing difference between couples with the extension of time after pregnancy loss(1 month, 3 months, 6 months).

  1 year

• Does pregnancy loss after IVF transplantation have a differential effect on post-traumatic stress responses between couples?

  The questionnaires used were the Posttraumatic Stress Disorder Checklist-Civilian Version (PCL-C). PCL-C contains 17 items, with an overall symptom severity score out of 85, including 3 dimensions of re-experience, avoidance and hypervigilance. Each item was scored on a scale of 1 to 5(1= no reaction,5= extremely severe reaction). Higher score indicates greater Posttraumatic Stress. Compare whether there is a growing difference between couples with the extension of time after pregnancy loss(1 month, 3 months, 6 months).

  1 year

Study Arms (2)

The female spouse of a couple

Women in couples with IVF pregnancy loss and IVF failure

The male spouse of a couple

Men in couples with IVF pregnancy loss and IVF failure

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study was a prospective cohort study. The participants were from couples who underwent in vitro fertilization at the Reproductive Center of the First Hospital of Jilin University.Further questionnaires were conducted for couples with IVF failure and pregnancy loss

You may qualify if:

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

You may not qualify if:

• Couples with contraindications to pregnancy.
• Couples who undergo donor IVF.
• Infertility women caused by organic lesions.
• Couples with previous mental disorders.

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

the first hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Related Publications (14)

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• 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.

  PMID: 33313697 RESULT

• 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.

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• 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.

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  PMID: 33032364 RESULT

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Qi Xi, doctorate

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qi Xi, doctorate

CONTACT

15804303801; xiqi@jlu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 26, 2024
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

CN (1)