| CTRI Number |
CTRI/2025/10/096089 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
12/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Infertility and its impact:
On psychological wellbeing, out of pocket expenditure, Coping strategies among infertile couples and their influence on psychosocial well being of partners, infertility treatment at a tertiary centre in rural
southern India. |
|
Scientific Title of Study
|
Infertility and its impact: A Cross-sectional
study on psychological wellbeing, Out of
pocket expenditure, and Coping strategies
among couples at a tertiary centre in rural
southern India. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bollam Manisha |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Bibinagar |
| Address |
All India Institute of Medical services
OBG- 21
Bibinagar, Bhuvanagiri
Telangana
Hyderabad
TELANGANA
508126
India |
| Phone |
08341894289 |
| Fax |
|
| Email |
veeraswamy45bollam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Naina Kumar |
| Designation |
Additional professor |
| Affiliation |
AIIMS, Bibinagar |
| Address |
All India Institute of Medical sciences
Bibinagar, Bhuvanagiri
Telangana
Hyderabad
TELANGANA
508126
India |
| Phone |
9552515600 |
| Fax |
|
| Email |
drnainakumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bollam Manisha |
| Designation |
Junior Resident |
| Affiliation |
AIIMS, Bibinagar |
| Address |
All India Institute of Medical services
OBG- 21
Bibinagar, Bhuvanagiri
Telangana
Hyderabad
TELANGANA
508126
India |
| Phone |
08341894289 |
| Fax |
|
| Email |
veeraswamy45bollam@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
BOLLAM MANISHA |
| Address |
All India Institute of Medical sciences
Bibinagar, Bhuvanagiri
Telangana- 508126 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr BOLLAM MANISHA |
All India Institute of Medical sciences |
Obstetrics and Gynaecology department
All India Institute of Medical sciences
Bibinagar, Bhuvanagiri
Telangana- 508126
Hyderabad
TELANGANA |
8341894289
veeraswamy45bollam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (AIIMS BBN-IEC) AIIMS Hyderabad Metropolitan Region, Telangana- 508126 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
INFERTILE COUPLE |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All infertile couples between 21-50 yrs of age and married for more than 2 yrs with complaints of infertility will be enrolled as study participants. |
|
| ExclusionCriteria |
| Details |
Couples married for less than a year, if either partner has a cognitive impairment affecting mental capacity, or if they decline to participate will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the psychosocial impact, financial burden of infertility diagnosis and treatment, to analyse coping strategies in both partners |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Most infertile couples face problems with mental and social wellbeing, coping strategies. This study aims to evaluate the psychosocial impact, to assess the out of pocket expenditure on infertility diagnosis and treatment, to identify and analyse coping strategies in both partners and their influence on psychosocial well being of partners, infertility treatment. |