| CTRI Number |
CTRI/2025/02/080623 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
14/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Fertility related quality of life and depressive anxiety symptoms in infertile couple with male factor infertility a cross sectional study |
|
Scientific Title of Study
|
Fertility related quality of life and depressive anxiety symptoms in infertile couple with male factor infertility |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Malik Humaira |
| Designation |
Junior resident |
| Affiliation |
AIIMS NEW DELHI |
| Address |
AIIMS New delhi
Department of obstetrics and gynaecology
New Delhi
DELHI
110029
India |
| Phone |
6006286697 |
| Fax |
|
| Email |
malikhumaira765@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Juhi Bharti |
| Designation |
Additional professor |
| Affiliation |
AIIMS NEWDELHI |
| Address |
Aiims newdelhi
Department of obstetrics and gynaecology
New Delhi
DELHI
110029
India |
| Phone |
8527570849 |
| Fax |
|
| Email |
drjuhigeorgian.04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Juhi Bharti |
| Designation |
Additional professor |
| Affiliation |
AIIMS NEWDELHI |
| Address |
Aiims new delhi
Department of obstetrics and gynaecology
New Delhi
DELHI
110029
India |
| Phone |
8527570849 |
| Fax |
|
| Email |
drjuhigeorgian.04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aiims new delhi
Ansari Nagar
110029 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| 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 |
| Malik Humaira |
Aiims new delhi |
Department of obstetrics and gynaecology
New Delhi
DELHI |
6006286697
malikhumaira765@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS NEWDELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
INFERTILE COUPLES WITH MALE FACTOR INFERTILITY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Couple with male factor infertility
2.Willing to participate in study |
|
| ExclusionCriteria |
| Details |
1.Unexplained infertility
2.Malignancy
3.Psychiatric disorder
4.Chronic medical illness
5.PCOS or endometriosis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.FERTIQOL score of male partner in couples with male factor infertility
2.FERTIQOL SCORE of female partner in couples with male factor infertility
3.DASS-42 score of male partner in couples with male factor infertility
4.DASS-42 score of female partner in couples with male factor infertility |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Correlation of FertiQol scores with DASS-42 scores
2.Comparision of FertiQol scores in male partner versus female partner in couples with male factor infertility
3.Comparision of DASS-42 scores in male partner versus female partner in couples with male factor infertility |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/03/2025 |
| 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="2"
Months="6"
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
|
THE EXISTING LITERATURE REVOLVE AROUND FEMALE PSYCHOLOGICAL BURDEN IN ASSISTED TREATMENTS AND AIM OF REDUCING IT. THERE IS HOWEVER PAUCITY OF LITERATURE TO QOL IN MALES ESPECIALLY WITH MALE FACTOR INFERTILITY.WHILE MALE INFERTILITY CAN LEAD TO SUBSTANTIAL DISTRESS TARGETED INTERVENTIONS AND SUPPORT SYSTEM CAN IMPROVE OUTCOME |