| CTRI Number |
CTRI/2020/11/029076 [Registered on: 12/11/2020] Trial Registered Prospectively |
| Last Modified On: |
04/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Newer semen related diagnostic test for male infertility |
|
Scientific Title of Study
|
Testis Expressed Sequence 101, Prostate Specific Antigen Antibodies and Malondialdehyde Acid in Qualitative Assessment of Seminal Plasma in Male Infertility: A Comparative Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naina Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Mangalagiri |
| Address |
Room number 234, 3rd floor, Department of Obstetrics and Gynecology
All India Institute of Medical Sciences, Mangalagiri
House number 242, C Block, Poojithas waterfront Apartments, Tadepalli, Guntur
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9552515600 |
| Fax |
|
| Email |
drnainakumar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Naina Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Mangalagiri |
| Address |
Room number 234, 3rd floor, Department of Obstetrics and Gynecology
All India Institute of Medical Sciences, Mangalagiri
Room number 234, 3rd floor, Department of Obstetrics and Gynecology
All India Institute of Medical Sciences, Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9552515600 |
| Fax |
|
| Email |
drnainakumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Naina Kumar |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Mangalagiri |
| Address |
Room number 234, 3rd floor, Department of Obstetrics and Gynecology
All India Institute of Medical Sciences, Mangalagiri
Room number 234, 3rd floor, Department of Obstetrics and Gynecology
All India Institute of Medical Sciences, Mangalagiri
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9552515600 |
| Fax |
|
| Email |
drnainakumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Mangalagiri |
|
|
Primary Sponsor
|
| Name |
AIIMS Mangalagiri |
| Address |
All India Institute of Medical Sciences, Mangalagiri |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Naina Kumar |
All India Institute of Medical Sciences, Mangalagiri |
Room number 234, 3rd floor, Department of Obstetrics and Gynecology, AIIMS, Mangalagiri
All India Institute of Medical Sciences, Mangalagiri
Guntur
ANDHRA PRADESH |
9552515600
drnainakumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-AIIMS Mangalagiri |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N460||Azoospermia, (2) ICD-10 Condition: N469||Male infertility, unspecified, (3) ICD-10 Condition: N461||Oligospermia, (4) ICD-10 Condition: N468||Other male infertility, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
Cases: All couples with male factor infertility as diagnosed on semen analysis will be included as cases
Controls: All male partners of infertile couples with normal semen analysis will be enrolled as controls.
The male partners in both cases and controls will be selected from 20-50 years of age group.
|
|
| ExclusionCriteria |
| Details |
Male partners with acute infection, fever, subjects currently on some infertility treatment or drugs, subjects with chronic diseases like diabetes mellitus, renal or liver diseases, prostate or any other malignancy, subjects with aspermia, cryptorchidism, bilateral absence of vasa deferens (CABVD), testicular dysgenesis syndrome or any other congenital abnormalities, subjects with Hypospadias or Retrograde ejaculation will be excluded from cases and controls. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the role of seminal plasma TEX 101, PSA antibodies and MDA levels as biomarkers of male infertility. |
The values of seminal plasma TEX 101, PSA antibodies and MDA levels as biomarkers of male infertility will be assessed after 1 year.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To develop effective non - invasive seminal plasma biomarkers for detection of causes of male infertility.
|
Comparison of TEX 101, Prostate specific antigen antibodies and MDA between cases and controls will be done after 10-12 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
01/12/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
37. Korbakis D, Schiza C, Brinc D, Soosaipillai A, Karakosta TD, Légaré C, et al. Preclinical evaluation of a TEX101 protein ELISA test for the differential diagnosis of male infertility. BMC Med. 2017;15(1):60. doi: 10.1186/s12916-017-0817-5.
17. Cuppett VA, Sikka SC, Naz RK. Presence of PSA antibodies in seminal plasma of infertile men. Front Biosci (Elite Ed). 2017;9:258-265. PubMed PMID: 28199189.
26. Khodair HA, Mahran Z, Hashim O, Omran T. Evaluation of lipid peroxidation in cases of idiopathic male infertility: correlation with the hypo-osmotic swelling test. Egypt J Dermatol Venerol 2013;33:42-5. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Infertility is a major problem now-a-day and both male
and female factor infertility are rising. Males are solely responsible for around 20-30% of
infertility cases but contribute to 50% of cases overall. According to WHO the
estimated prevalence of primary infertility in India ranges between 3.9 and
16.8% with a prevalence of 5% in Andhra Pradesh. Male infertility is multifactorial in origin with
environmental, genetic, life-style changes, oxidative stress, all contributing
in its development. Semen analysis is considered as gold standard test for
diagnosis of male infertility, but it is crude method as seminal fluid
composition gets affected by environmental factors, infections and other
pathologies, leading to unreliable reports and delay in diagnosis and
treatment.10 Hence, newer tests are being assessed including seminal
biomarkers for better estimation of male infertility and its underlying cause.
Human seminal fluid contains highest concentration of molecules derived from male
reproductive glands, which can be studied to know cause of male infertility.
Some of these seminal plasma biomarkers include Testicular expressed
sequence 101 (TEX 101) located on plasma membrane of germ cells during all
stages of spermatogenesis. It is essential for sperm maturation, zona binding
and can differentiate between obstructive and non-obstructive azoospermia.
Another important biomarker for immuno-infertility is Prostatic specific
antigen antibodies. Presence of these antibodies have been identified as an
important cause of male infertility. Furthermore, mammalian spermatozoa are rich in
polyunsaturated fatty acids, which are vulnerable to reactive oxygen species
attack. One end-product of this sperm lipid peroxidation is malondialdehyde
acid (MDA). High levels of seminal MDA cause oxidative damage to the sperm
membranes.
Hence, study will be conducted to assess role of
seminal plasma TEX 101, PSA antibodies and MDA levels in patients with male
infertility, so that newer non-invasive methods can be developed for better
management of male infertility. |