| CTRI Number |
CTRI/2020/09/027720 [Registered on: 10/09/2020] Trial Registered Prospectively |
| Last Modified On: |
10/09/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Semen parameters in patients with cancer |
|
Scientific Title of Study
|
A retrospective study on semen parameters in a population of Indian male patients with cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ASHWINI N |
| Designation |
SENIOR CONSULTANT IN REPRODUCTIVE MEDICINE |
| Affiliation |
GUNASHEELA SURGICAL AND MATERNITY HOSPITAL |
| Address |
Department of Reproductive Medicine, No. 1 Dewan N. Madhava Rao Road, Basavanagudi,Bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
080-4646260 |
| Fax |
|
| Email |
ashwonder.84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHWINI N |
| Designation |
SENIOR CONSULTANT IN REPRODUCTIVE MEDICINE |
| Affiliation |
GUNASHEELA SURGICAL AND MATERNITY HOSPITAL |
| Address |
Department of Reproductive Medicine, No. 1 Dewan N. Madhava Rao Road, Basavanagudi,Bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
080-4646260 |
| Fax |
|
| Email |
ashwonder.84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ASHWINI N |
| Designation |
SENIOR CONSULTANT IN REPRODUCTIVE MEDICINE |
| Affiliation |
GUNASHEELA SURGICAL AND MATERNITY HOSPITAL |
| Address |
Department of Reproductive Medicine, No. 1 Dewan N. Madhava Rao Road, Basavanagudi,Bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
080-4646260 |
| Fax |
|
| Email |
ashwonder.84@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gunasheela Surgical and Maternity Hospital, No.1 Dewan N. Madhava Roa Road, Basavanagudi, Bangalore - 560 004 |
|
|
Primary Sponsor
|
| Name |
Gunasheela Surgical and Maternity Hospital |
| Address |
No. 1, Dewan N. Madhava Rao Road, Basavanagudi, Bangalore - 560 004. |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 ASHWINI N |
Gunasheela Surgical and Maternity Hospital |
No.1 Dewan N. Madhava Rao Road, Basavanagudi,
Bangalore
KARNATAKA |
080-46462600
ashwonder.84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Gunasheela Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Male |
| Details |
Cancer Patient planned for fertility preservation before commencing Chemo therapy or radio therapy |
|
| ExclusionCriteria |
| Details |
Prepubertal males |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To categorize sperm health in patients with commonly known sites of cancer to aid in fertility preservation. |
From 2010 to 2019 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To aid in medical counseling prior to sperm banking and cancer therapy for fertility preservation |
From 2010 to 2019 |
|
|
Target Sample Size
|
Total Sample Size="377"
Sample Size from India="377"
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)
|
01/10/2020 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will be published in suitable journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Abstract Title: A retrospective study on semen parameters in a population of Indian male patients with cancer Aim: To categorize sperm health in patients with commonly known sites of cancer to aid in fertility preservation. Cancer treatment has radically improved and survival rates for male patients with cancer have increased, particularly in men of reproductive age (14-35 age). The most common types of cancers in male patients of a reproductive age are leukemia, Hodgkin’s lymphomas and testicular germ cell tumours. There is a dire need to investigate the semen quality amongst these cancer patients, as it allows for targeted counselling from medical professionals before opting for fertility preservation options. 399 male cancer patients between 2009 and 2019 were referred to Gunasheela Surgical and Maternity Hospital to explore fertility preservation options before commencing their cancer treatment. Before the sperm could be cryopreserved, they were subjected many lab-based analysis. These included semen volume, pH, total sperm count, sperm motility and analysis of sperm morphology. These semen data are then descriptively analysed, with respect to cancer types. This study will aim to understand sperm health between commonly cancers in young male patients, specifically in India. |