| CTRI Number |
CTRI/2024/04/066322 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of letrozole and anastrozole in improving semen profile of subferile men |
|
Scientific Title of Study
|
Comparison of Letrozole vs. Anastrozole in improving semen parameters of subfertile men with moderate to severe oligoasthenozoospermia: A randomised controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nidhi Chaudhary |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Obstetrics and Gynaecology, Womens and Children Hospital
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9580167739 |
| Fax |
|
| Email |
nidhi.chaudhary1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kubera NS |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Obstetrics and Gynaecology, Womens and Children Hospital
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442550604 |
| Fax |
|
| Email |
ns.drkubera@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kubera NS |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Obstetrics and Gynaecology, Womens and Children Hospital
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442550604 |
| Fax |
|
| Email |
ns.drkubera@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research intramural fund |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Obstetrics and Gynaecology, Womens and Children Hospital , Dhanvantari Nagar, Puducherry |
| 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 |
| Kubera NS |
JIPMER |
Dhanvantari nagar , puducherry
Pondicherry
PONDICHERRY |
9442550604
ns.drkubera@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee of JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N461||Oligospermia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anastrozole Group |
Men diagnosed with moderate to severe oligoasthenozoospermia (Including Cryptozoospermia in one of the samples) is treated with Anastrozole 1 mg orally, once daily for 3 months |
| Intervention |
Letrozole Group |
Men diagnosed with moderate to severe oligoasthenozoospermia (Including Cryptozoospermia in one of the samples) are treated with letrozole 2.5mg orally, once daily , for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Subfertile men with moderate to severe oligoasthenozoospermia attending male infertility clinic, WCH, JIPMER during the study period. |
|
| ExclusionCriteria |
| Details |
1. Ejaculatory duct obstruction or surgery for male factor infertility
2.History of mumps orchitis, chronic tobacco and alcohol abuse.
3.Ongoing medical treatment including gonadotropins, anabolic steroids, and cancer chemotherapy
4. Leucocytospermia (more than 1 million/ml).
5. Severe varicocele and previously diagnosed Klinefelter syndrome. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of letrozole and anastrozole on semen parameters amongst men with Oligoasthenoteratozoospermia. |
At end of study (2years approx) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To monitor the side effects of letrozole and anastrozole
2. To measure the alterations in serum oestradiol and testosterone produced by letrozole and anastrozole. |
At end of study (2years approx) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Thia is a randomised, controlled trail, comparing Letrozole vs. Anastrozole in improving semen parameters of subfertile men with moderate to severe oligoasthenozoospermia . It will be conducted in patients coming to WCH , JIPMER, Puducherry hospital. The primary outcome measures will be the effect of letrozole and anastrozole on semen parameters amongst men with Oligoasthenoteratozoospermia.Secondary outcomes will be the side effects of letrozole and anastrozole
and to measure the alterations in serum oestradiol and testosterone produced by letrozole and anastrozole. |