IVF Failure and Pregnancy Loss on Couples' Psychological Stress

Psychological Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06385444
• Other study ID #: 2024-HS-020
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: The First Hospital of Jilin University
• Contact: Qi Xi, doctorate
• Phone: 15804303801
• Email: xiqi[@]jlu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 1, 2025
• Est. primary completion date: May 1, 2025
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Fertilization in Vitro
• Fetal Death
• Post-traumatic Stress
• Pregnancy Loss
• Psychological Stress
• Stress, Psychological

Locations

Country	Name	City	State
China	the first hospital of Jilin University	Chang chun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

References & Publications (14)

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. — View Citation

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. — View Citation

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.2010.48 — View Citation

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 — View Citation

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. — View Citation

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 R — View Citation

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 Rep — View Citation

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- — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — 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. Hum Reprod. 2017 Sep 1;32(9):1786-1801. doi: — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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