IVF Failure and Pregnancy Loss on Couples' Psychological Stress

April 25, 2024 updated by: The First Hospital of Jilin University

Effects of Implantation Failure and Pregnancy Loss After in Vitro Fertilization on Couples' Psychological Stress

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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?

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jilin
      • Chang chun, Jilin, China, 130000
        • The First Hospital of Jilin University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
As the number of failed IVF implants increases, does it increase the difference in anxiety and depression between couples?
Time Frame: 1 year

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?
Time Frame: 1 year

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?
Time Frame: 1 year

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?
Time Frame: 1 year

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Investigators

  • Principal Investigator: Qi Xi, doctorate, The First Hospital of Jilin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

April 17, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-HS-020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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