Fertilization in VitroNCT06385444
IVF Failure and Pregnancy Loss on Couples' Psychological Stress
An observational study of Fertilization in Vitro and Pregnancy Loss, run by The First Hospital of Jilin University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Fertilization in Vitro, Pregnancy Loss, Psychological Stress
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- All sexes
- Adult
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
Who may be able to join
- 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.
Who cannot join
- Couples with contraindications to pregnancy.
- Couples who undergo donor IVF.
- Infertility women caused by organic lesions.
- Couples with previous mental disorders.
Trial locations and contacts
1 site in 1 country.
China1 site
the first hospital of Jilin University
Changchun, Jilin, 130000
Qi Xi, doctorate, 15804303801, xiqi@jlu.edu.cn
About this study
Official title: 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.
Read the 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.
- Does the number of IVF implant failures have a differential effect on anxiety, depression and fertility stress in women and their partners?
- 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?
- Keywords
- IVF failure, IVF pregnancy Loss, Psychological Stress, Post-traumatic Stress, Anxiety and depression
- Medical subject headings
- Stress, Psychological, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Fertilization in VitroStudies of the same condition, open and under way.
- More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Hospital of Jilin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qi Xi, doctorate, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385444
- Sponsor's protocol ID
- 2024-HS-020
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29117321Vander 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.
PubMed 29555319Agarwal 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.
PubMed 25928197Chachamovich 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.
PubMed 20443659Cates 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.
PubMed 2863605Khademi 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.
PubMed 18086173Wischmann T. Implications of psychosocial support in infertility--a critical appraisal. J Psychosom Obstet Gynaecol. 2008 Jun;29(2):83-90. doi: 10.1080/01674820701817870.
PubMed 18484439Murphy 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.
PubMed 9830973Facchinetti 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.
PubMed 9022608Cimadomo 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.
PubMed 33313697ESHRE 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.
PubMed 37332387ESHRE 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.
PubMed 36873081Cumming 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.
PubMed 17655731Farren 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.
PubMed 33032364
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Implantation Failure and Pregnancy Loss After in Vitro Fertilization on Couples' Psychological Stress
- ClinicalTrials.gov ID
- NCT06385444
- Acronym / sponsor ID
- 2024-HS-020
- Keywords
- IVF failure, IVF pregnancy Loss, Psychological Stress, Post-traumatic Stress, Anxiety and depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The First Hospital of Jilin UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Does the number of IVF implant failures have a differential effect on anxiety, depression and fertility stress in women and their partners?
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Age groups
- Adult
- 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
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- Couples with contraindications to pregnancy.
- Couples who undergo donor IVF.
- Infertility women caused by organic lesions.
- Couples with previous mental disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Results publication: PubMed 29117321Zegers-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.
- Results publication: PubMed 29555319Vander 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.
- Results publication: PubMed 25928197Agarwal 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.
- Results publication: PubMed 20443659Chachamovich 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.
- Results publication: PubMed 2863605Cates 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.
- Results publication: PubMed 18086173Khademi 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.
- Results publication: PubMed 18484439Wischmann T. Implications of psychosocial support in infertility--a critical appraisal. J Psychosom Obstet Gynaecol. 2008 Jun;29(2):83-90. doi: 10.1080/01674820701817870.
- Results publication: PubMed 9830973Murphy 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.
- Results publication: PubMed 9022608Facchinetti 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.
- Results publication: PubMed 33313697Cimadomo 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.
- Results publication: PubMed 37332387ESHRE 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.
- Results publication: PubMed 36873081ESHRE 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qi Xi, doctorate principal investigator
The First Hospital of Jilin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertilization in Vitro and Pregnancy Loss, run by The First Hospital of Jilin University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qi Xi, doctorate (15804303801, xiqi@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
As the number of failed IVF implants increases, does it increase the difference in anxiety and depression between couples? (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06385444, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.