The study is a a clinical trial to study the effectiveness of psychotherapy in reducing emotional distress in infertility couples, while they undergo infertility treatment (IUI) and face unsuccessful outcomes in such treatment cycles.
- Conditions
- Primary Infertility
- Registration Number
- CTRI/2015/07/005973
- Lead Sponsor
- Selfsponsored
- Brief Summary
This study was a randomized controlled single centre trail, with a 2group design, to test the effectiveness of modifiedMindfulness Based Cognitive Therapy for distressed coupleswith infertility undergoing unsuccessful outcomes on Intra Uterine Insemination(Experimental group) , in comparison to those distressedcouples with infertility undergoing unsuccessful outcomes on Intra UterineInsemination, who are in treatment as usual (The waitlistedcontrol group).
The primary outcome is the change in scores on mean infertilityspecific stress experienced by each of the partners in the couple, after 2months (from pre-post intervention), among the two study groups.
The secondary outcome was changes in scores on mean mindfulness skills,symptoms of depression, symptoms of anxiety, marital distress and Fertilityrelated quality of life in the couples after 2 months (from pre-postintervention), among the two study groups.
**Results:** The modified MBCT was reasonably accepted byinfertile couples. The total attrition was below 30%. Mean Compliance duringsessions was above 70%. At follow-up, the mean compliance was 53% in women and33% in men. Factors associated with the take-up of therapy, compliance andattrition were identified. There were no adverse effects from practice of MBCT.
In women, between-group differences obtained on ISS, Anxiety,Depression, FertiQol and Coping were found to be statisticallysignificant.
In men between-group differences obtained on ISS, FertiQol andMindfulness coping were found to be statistically significant.
This study also provides a limited evidence for enhanced fertilityoutcomes in MBCT group. Superior outcomes were also observed in couples whounderwent booster MBCT sessions and in those who conceived as well as continuedMBCT practice during their early gestational period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 30
- Inclusion Criteria •Persons who give consent for the study, with female partner of couple of Age 20 years to 35 years , Educated at least up to 10th standard and should be able to read and write Kannada.
- •Couples who are coming as new cases to MARC , with p/h/o diagnosis of primary infertility •Patients who have 5-10 years of p/h/o undergoing Assisted Reproductive Treatments •Couples with PCOD in female partner and /or oligospermia and varicocele in male partner •Suitable for intra-uterine insemination •Neither partner of the couple meets any diagnostic criteria on Mini International Neuropsychiatric Interview ( English version 5.0).
- •Having a significant infertility specific stress score , in either partner of the couple ,( i.e. raw score of 167 or above as assessed in females and of 147 or above as assessed in males) as measured on Fertility Problem Inventory.
- •Couples with >10 years of diagnosis of primary infertility and p/h/o undergoing Assisted Reproductive Treatments.
- •Couples who have undergone surgery in the last 3 months .
- •Couples who are going to under surgeries in the coming 3 months •Couples suitable for IVF •Couples suitable for donor egg/ donor insemination •Couples in which female partner has a diagnosis of recent cyst/ fibroids/ endometrioses and /or males with a diagnosis of azoospermia/aspermia.
- •Couples in which either partner with diagnosed with any psychiatric disorder or on Rx for psychiatric comorbidities ,or meets the diagnostic criteria on Mini International Neuropsychiatric Interview ( English version 5.0).
- •Having an insignificant infertility specific stress score in both the partner of the couple ( raw score of or less than 167 as assessed in females and equal/less than 147 as assessed in males) as measured on Fertility Problem Inventory.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Infertility Specific Stress assessed by Fertility Problem Inventory Pre to Post Intervention, 1 month
- Secondary Outcome Measures
Name Time Method ii.Mindfulness skills : Assessed by Kentucky Inventory for Mindfulness Skills iii.Anxiety and Depression: Assessed by Hamilton anxiety and depression scale. Pre to Post Intervention, 1 month v.Fertility related Quality of life : Assessed by Ferti QOL
Trial Locations
- Locations (1)
DEPT OF OBSTETRICS AND GYNAECOLOGY, DIVISION OF REPRODUCTIVE MEDICINE,MARC
🇮🇳Udupi, KARNATAKA, India
DEPT OF OBSTETRICS AND GYNAECOLOGY, DIVISION OF REPRODUCTIVE MEDICINE,MARC🇮🇳Udupi, KARNATAKA, IndiaDr Pratap Kumar Professor and Head Division of reproductive medicine Dept of OBGPrincipal investigator08202922162pratap.kumar@manipal.edu