IVF Failure and Pregnancy Loss on Couples' Psychological Stress

Not yet recruiting

• Conditions: Post-traumatic Stress; Pregnancy Loss; Psychological Stress; Fertilization in Vitro

• Registration Number: NCT06385444
• Lead Sponsor: The First Hospital of Jilin University

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.

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 Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-25
• Last Update Submitted: 2024-04-25
• Study First Posted: 2024-04-26
• Last Update Posted: 2024-04-26
• Study Start: 2024-05-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Does pregnancy loss after IVF transplantation have a differential effect on anxiety and depression between couples?	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).
As the number of failed IVF implants increases, does it increase the difference in anxiety and depression between couples?	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.
As the number of failed IVF implants increases, does it increase the difference in fertility stress between couples?	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.
Does pregnancy loss after IVF transplantation have a differential effect on post-traumatic stress responses between couples?	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).

Trial Locations

Locations (1)

the first hospital of Jilin University; 🇨🇳 Chang chun, Jilin, China