| CTRI Number |
CTRI/2025/08/093046 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
13/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Infertility Affects Women’s Jobs and Daily Life Challenges |
|
Scientific Title of Study
|
Impact of Infertility on Women’s Workforce Participation and Associated Burden |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati Dhar |
| Designation |
Mch Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of reproductive medicine and surgery, Kasturba Hospital, KMC Manipal, Manipal academy of higher education, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9027509965 |
| Fax |
|
| Email |
dhar.swati.36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidyashree G Poojari |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of reproductive medicine and surgery, Kasturba Hospital, KMC Manipal, Manipal academy of higher education, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9901731619 |
| Fax |
|
| Email |
vidyashree.g@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidyashree G Poojari |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of reproductive medicine and surgery, Kasturba Hospital, KMC Manipal, Manipal academy of higher education, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9901731619 |
| Fax |
|
| Email |
vidyashree.g@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba medical College, Manipal, Udupi, Karnataka |
|
|
Primary Sponsor
|
| Name |
KMC Manipal |
| Address |
Kasturba Hospital, KMC Manipal, Madhav Nagar, Manipal, Udupi, Karnataka |
| Type of Sponsor |
Private medical college |
|
|
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 Swati Dhar |
Kasturba Hospital |
MARC OPD, Department of Reproductive medicine and surgery, KMC Manipal, Madhav nagar, Manipal
Udupi
KARNATAKA |
9027509965
dhar.swati.36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital, Institutional Ethics committee- 1 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N979||Female infertility, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Women who were employed at any point during their infertility journey. |
|
| ExclusionCriteria |
| Details |
Women with other medical conditions independently causing job loss.
Women with other social or psychological or financial conditions independently causing job loss.
Women unwilling to participate.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of women quitting or reducing work due to infertility. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Financial burden due to treatment. |
Baseline |
| Key predictors of workforce exit. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
25/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study will explore how infertility affects women’s participation in the workforce and the burdens they face as a result. This study will be conducted over one year at Kasturba Medical College, Manipal, it will involve 150 women aged 21–50 who have experienced infertility and were employed during their fertility journey. Using a structured questionnaire, validated psychological scales (PSS-4, GAD-7, PHQ-4), and in-depth interviews, the study aims to identify how many women reduce work hours or leave their jobs due to infertility, and to assess the financial, psychological, and social challenges they encounter. It will also compare the impact between employed and unemployed women and examine factors like treatment burden, societal expectations, and workplace discrimination. The findings aim to fill a critical gap in Indian data and support recommendations for more inclusive workplace policies for women undergoing fertility treatments. |