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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

Cognitive and Progressive Muscle Relaxation Intervention on Couple Undergoing IVF-ET

Clinicaltrials.gov identifier NCT03931187

Recruitment Status Completed

First Posted April 30, 2019

Last update posted July 21, 2020

Study Description

Brief 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. 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.

  • Condition or Disease:Infertility
  • Intervention/Treatment: Behavioral: Cognitive progressive muscular relaxation therapy
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Actual Enrollment: 46 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Supportive Care
  • Official Title: Cognitive and Progressive Muscle Relaxation Intervention on Couple Undergoing In Vitro Fertilization-Embryo Transfer Treatment
  • Actual Study Start Date: December 2019
  • Actual Primary Completion Date: June 2020
  • Actual Study Completion Date: July 2020
Arms and interventions
Arm Intervention/treatment
Experimental: Couple intervention arm
Intervention will be applied to the couple, both men and women.
Behavioral: Cognitive progressive muscular relaxation therapy
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 20-30 days during IVF-ET.
Experimental: Women intervention arm
Intervention will be applied to the women within the couple.
Behavioral: Cognitive progressive muscular relaxation therapy
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 20-30 days during IVF-ET.
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • 2. 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. Successful conception rate (%) [ Time Frame: The doctor will test whether it is successfully conceived 14 days after the embryo is implanted. The last intervention is on the day of embryo implantation. The investigators will count this 14 days after completion of intervention. ]
    The investigators will count the successful conception rate at each arms.
  • Secondary Outcome Measures: 1. 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). ]
    This is a kind of hormone closely related to stress, and the investigators will measure the level of Blood Cortisol by Blood test.
  • 2. 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). ]
    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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- Suffering from physical diseases such as severe heart, liver and kidney, and mental
disorders;

- Experiencing major traumatic events in the past 2 years.

Contacts and Locations
Contacts
Locations

China, Hunan
Infertility Reproductive Center, Second Xiangya Hospital, Central South University
Changsha

Sponsors and Collaborators

Central South University

More Information
  • Responsible Party: Central South University
  • ClinicalTrials.gov Identifier: NCT03931187 History of Changes
  • Other Study ID Numbers: Intervention on IVF-ET
  • First Posted: April 30, 2019 Key Record Dates
  • Last Update Posted: July 21, 2020
  • Last Verified: July 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Plan Description: The participants are not willing to share the data.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Central South University: cognitive psychotherapy
    progressive muscular relaxation
    in vitro fertilization and embryo transfer(IVF-ET)
    Couples Therapy
  • Additional relevant MeSH terms: Infertility