InfertilityNCT03931187
Double ABCX Theory Based Cognitive Psychotherapy Combined Progressive Muscle Relaxation Intervention on Women Undergoing IVF-ET
A study testing Cognitive progressive muscular relaxation therapy in people with Infertility, run by Central South University at 1 site in China.
Trial summary
The in vitro fertilization and embryo transfer(IVF-ET) is a therapy to help the infertile couples. The mental health status of couple under IVF-ET, commonly seen in depression and anxiety, is found to be closely related to the success of IVF-ET. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infertility
- What is being tested?
- Cognitive progressive muscular relaxation therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2018to 1 Jul 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The couple who are eligible for in vitro fertilization-embryo transfer (IVF-ET) treatment;
- Junior high school and above;
- voluntarily accepted for investigation and signed informed consent.
Who cannot join
- Suffering from physical diseases such as severe heart, liver and kidney, and mental disorders;
- Experiencing major traumatic events in the past 2 years.
Trial locations and contacts
1 site in 1 country.
China1 site
Infertility Reproductive Center, Second Xiangya Hospital, Central South University
Changsha, Hunan, 410013
About this study
Official title: Double ABCX Theory Based Cognitive Psychotherapy Combined Progressive Muscle Relaxation Intervention on Women Undergoing In Vitro Fertilization-Embryo Transfer Treatment
The in vitro fertilization and embryo transfer(IVF-ET) is a therapy to help the infertile couples. The mental health status of couple under IVF-ET, commonly seen in depression and anxiety, is found to be closely related to the success of IVF-ET. This study aims to develop a intervention program combing cognitive psychotherapy and progressive muscle relaxation to ease the negative emotion and promote the success rate among couples undergoing IVF-ET.
- Conditions
- Infertility
- Being tested
- Cognitive progressive muscular relaxation therapy
- Keywords
- cognitive psychotherapy, progressive muscular relaxation, in vitro fertilization and embryo transfer(IVF-ET), Couples Therapy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive progressive muscular relaxation therapyBehavioural
This therapy combines cognitive psychotherapy and progressive muscular relaxation, intervened 6 times with 1-1.5 hour each time. The whole therapy will last round 28-30 days during IVF-ET.
| Study group | Role | What they receive |
|---|---|---|
| Women intervention arm | Experimental | Intervention will be applied to the women within the couple. Receives: Behavioral: Cognitive progressive muscular relaxation therapy |
| Couple intervention arm | Experimental | Intervention will be applied to the couple, both men and women. Receives: Behavioral: Cognitive progressive muscular relaxation therapy |
| Control arm | No intervention | The couple will receive the normal nursing care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of depression score
The Self-reported Depression Scale （SDS）will be used to assess the score of depression.The total score of SDS ranges from 0-80, with 40 as the cutoff. The higher the total score, the more depressive.
Measured: The investigators will measure the socre of depression at baseline and immediately after intervention ( the duration of intervention is around 1 month).
Change of anxiety score
The Self-reported Anxiety Scale (SAS) will be used to assess the score of anxiety.The total score of SAS ranges from 0-80, with 30 as the cutoff. The higher the total score, the more anxious.
Measured: The investigators will measure the socre of anxiety at baseline and immediately after intervention ( the duration of intervention is around 1 month).
Secondary outcomes (3)
Change of Blood Cortisol
This is a kind of hormone closely related to stress, and the investigators will measure the level of Blood Cortisol by Blood test.
Measured: The investigators will measure the socre of Blood Cortisol at baseline and immediately after intervention ( the duration of intervention is around 1 month).
Change of sleeping quality
The physical condition closely related to stress. The investigators will use Self-Rating Scale of Sleep to measure the sleeping quality of the participants. The total sore ranges from 5 to 50, with higher score reflects better sleep quality.
Measured: The investigators will measure the socre of sleeping quality at baseline and immediately after intervention ( the duration of intervention is around 1 month).
Successful conception rate (%)
The investigators will count the successful conception rate at each arms.
Measured: The doctor will test whether it is successfully conceived 4 weeks after the embryo is implanted. The last intervention is on the day of embryo implantation. The investigators will count this 4 weeks after completion of intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start1 Dec 2018
- Primary completion1 May 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anni Wang, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931187
- Sponsor's protocol ID
- Intervention on IVF-ET
- Status last verified
- Nov 2021
- First submitted
- 23 Apr 2019
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The participants are not willing to share the data.
Publications
Wang A, Zhang W, Li H, Guo Y, Yu NX, Zhang J. An 8-week community-based resilience group intervention for Chinese parents who lost their only child: A two-armed pragmatic waitlist-control trial. Psychol Trauma. 2025 Jan;17(1):225-234. doi: 10.1037/tra0001670. Epub 2024 Apr 22.
PubMed 38647487Chen D, Wang A, Zhang W, Guo Y, Yao S, Chen X, Zhang J. Effectiveness of double ABCX-based psychotherapy for psychological distress among women undergoing in vitro fertilization-embryo transfer: a three-arm randomized controlled trial. J Psychosom Obstet Gynaecol. 2023 Dec;44(1):2278015. doi: 10.1080/0167482X.2023.2278015. Epub 2023 Dec 6.
PubMed 38056467
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double ABCX Theory Based Cognitive Psychotherapy Combined Progressive Muscle Relaxation Intervention on Women Undergoing In Vitro Fertilization-Embryo Transfer Treatment
- ClinicalTrials.gov ID
- NCT03931187
- Acronym / sponsor ID
- Intervention on IVF-ET
- Conditions
- Infertility
- Keywords
- cognitive psychotherapy, progressive muscular relaxation, in vitro fertilization and embryo transfer(IVF-ET), Couples Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 30 Apr 2019 (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 in vitro fertilization and embryo transfer(IVF-ET) is a therapy to help the infertile couples. The mental health status of couple under IVF-ET, commonly seen in depression and anxiety, is found to be closely related to the success of IVF-ET. This study aims to develop a intervention program combing cognitive psychotherapy and progressive muscle relaxation to ease the negative emotion and promote the success rate among couples undergoing IVF-ET.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women intervention arm | Experimental | Behavioral: Cognitive progressive muscular relaxation therapyIntervention will be applied to the women within the couple. |
| Couple intervention arm | Experimental | Behavioral: Cognitive progressive muscular relaxation therapyIntervention will be applied to the couple, both men and women. |
| Control arm | No intervention | –The couple will receive the normal nursing care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The couple who are eligible for in vitro fertilization-embryo transfer (IVF-ET) treatment;
- Junior high school and above;
- voluntarily accepted for investigation and signed informed consent.
Key exclusion criteria (2 listed)
- Suffering from physical diseases such as severe heart, liver and kidney, and mental disorders;
- Experiencing major traumatic events in the past 2 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive progressive muscular relaxation therapyThis therapy combines cognitive psychotherapy and progressive muscular relaxation, intervened 6 times with 1-1.5 hour each time. The whole therapy will last round 28-30 days during IVF-ET. | Behavioural | Couple intervention arm, Women intervention arm |
Primary outcome
Change of depression score
Time frame: The investigators will measure the socre of depression at baseline and immediately after intervention ( the duration of intervention is around 1 month).
The Self-reported Depression Scale （SDS）will be used to assess the score of depression.The total score of SDS ranges from 0-80, with 40 as the cutoff. The higher the total score, the more depressive.
Change of anxiety score
Time frame: The investigators will measure the socre of anxiety at baseline and immediately after intervention ( the duration of intervention is around 1 month).
The Self-reported Anxiety Scale (SAS) will be used to assess the score of anxiety.The total score of SAS ranges from 0-80, with 30 as the cutoff. The higher the total score, the more anxious.
3 secondary outcomes
Change of Blood Cortisol
Time frame: The investigators will measure the socre of Blood Cortisol at baseline and immediately after intervention ( the duration of intervention is around 1 month).
Change of sleeping quality
Time frame: The investigators will measure the socre of sleeping quality at baseline and immediately after intervention ( the duration of intervention is around 1 month).
Successful conception rate (%)
Time frame: The doctor will test whether it is successfully conceived 4 weeks after the embryo is implanted. The last intervention is on the day of embryo implantation. The investigators will count this 4 weeks after completion of intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Derived from this study: PubMed 38647487Wang A, Zhang W, Li H, Guo Y, Yu NX, Zhang J. An 8-week community-based resilience group intervention for Chinese parents who lost their only child: A two-armed pragmatic waitlist-control trial. Psychol Trauma. 2025 Jan;17(1):225-234. doi: 10.1037/tra0001670. Epub 2024 Apr 22.
- Derived from this study: PubMed 38056467Chen D, Wang A, Zhang W, Guo Y, Yao S, Chen X, Zhang J. Effectiveness of double ABCX-based psychotherapy for psychological distress among women undergoing in vitro fertilization-embryo transfer: a three-arm randomized controlled trial. J Psychosom Obstet Gynaecol. 2023 Dec;44(1):2278015. doi: 10.1080/0167482X.2023.2278015. Epub 2023 Dec 6.
- Individual participant dataSharing planned: No. The participants are not willing to share the data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive progressive muscular relaxation therapy in people with Infertility, run by Central South 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 14 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of depression score (time frame: The investigators will measure the socre of depression at baseline and immediately after intervention ( the duration of intervention is around 1 month).). The study lists 2 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 NCT03931187, which also lists 2 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 14 Dec 2021.