| CTRI Number |
CTRI/2026/03/106403 [Registered on: 17/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Psychological Schemas and emotional well-being in men with infertility |
|
Scientific Title of Study
|
Association between Maladaptive Schema and male factor infertility a case control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Moanarola |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Moanarola Ao |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Biochemistry
Maulana Azad Medical College and Associated Hospitals
Bahadur Shah Zafar Marg
Central Delhi
New Delhi
DELHI
110002
India |
| Phone |
9811994312 |
| Fax |
|
| Email |
moanarola@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bidhan Chandra Koner |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Biochemistry
Maulana Azad Medical College and Associated Hospitals
Bahadur Shah Zafar Marg
Central Delhi
New Delhi
DELHI
110002
India |
| Phone |
9968604229 |
| Fax |
|
| Email |
bckoner@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Moanarola Ao |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Biochemistry
Maulana Azad Medical College and Associated Hospitals
Bahadur Shah Zafar Marg
Central Delhi
New Delhi
DELHI
110002
India |
| Phone |
9811994312 |
| Fax |
|
| Email |
moanarola@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College,2 Bahadur Shah Zafar Marg 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2, Bahadur Shah Zafar Marg, New Delhi - 110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Biochemistry |
Maulana Azad Medical College and Associated Hospitals
Bahadur Shah Zafar Marg
Central Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Moanarola Ao |
Maulana Azad Medical College |
Room no 205 2nd floor Department of Biochemistry Pathology Block Maulana Azad Medical College New Delhi
Central
DELHI |
9811994312
moanarola@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospital (Lok Nayak, G.B. Pant Institute of Postgraduate Medical Education (GIPMER) And Research Hospital, Guru Nanak Eye Centre, New Delhi 110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N468||Other male infertility, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
23.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
For cases: subjects with male factor infertility who attend for treatment of primary infertility to Gynaecology and Obstetrics or Surgery Department
For controls: Male partner of primary infertile couple who are having normal seminal parameters and infertility is purely due to female cause |
|
| ExclusionCriteria |
| Details |
1. Subjects with congenital abnormality of the Genito urinary tract.
2. Subjects with Varicocele or duct obstruction (post testicular e.g. inflammatory block or surgical trauma) as diagnosed by Surgeon.
3. Subjects with any major physical illness like Cancer, Renal failure grade 2 and above, Hepatic failure, CVA with residual paralysis, ischemic heart disease more than grade 2 or any major acute illnesses, uncontrolled & complicated Diabetes Mellitus.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Male Factor Infertility: As assessed from seminal analysis parameters (sperm count, sperm motility and sperm morphology), sexual function and serum levels of fertility hormones.
2.Psychological Distress: As assessed by General Health Questionnaire 12 (GHQ12). Employ the binary scoring method (0-0-1-1) for all questions. Score more than 2 is taken as a cut-off point. |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare General Health Questionairre-12 (GHQ-12) score & Brief Sexual Function Inventory (BSFI) score between subjects with male factor infertility & controls.
2.To study the relationship between
a.Schema score & GHQ-12 score
b.Schema score & BSFI score
c.Schema score & semen analysis parameters |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/04/2026 |
| 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 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
|
This study aims to evaluate the association between maladaptive schemas and male factor infertility. The study will compare schema scores with fertility hormone levels in men diagnosed with male factor infertility and healthy controls. In addition, psychological well-being and sexual function will be assessed using the General Health Questionnaire-12 (GHQ-12) and the Brief Sexual Function Inventory (BSFI). |