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EFFECTS OF TREATMENT OF SEMEN ABNORMALITIES WITH CLOMIPHENE CITRATE

Not Applicable
Conditions
Health Condition 1: null- NORMOGONADOTROPHIC OLIGOZOOSPERMIA
Registration Number
CTRI/2012/05/002689
Lead Sponsor
DR SUDHINDRA MOHAN BHATTACHARYA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
30
Inclusion Criteria

HUSBANDS OF INFERTILE COUPLES WILL UNDERGO SEMEN ANALYSIS. THOSE WITH OLIGOZOOSPERMIA (SPERM COUNT LESS THAN 20 MILLION/ML)WILL UNDERGO SERUM FSH AND TESTOSTERONE TESTED. IF FSH VALUE IS NORMAL, THEN CLOMIPHENE CITRATE 25 MG WILL BE GIVEN DAILY ORALLY. AFTER 2 WEEKS FSH AND TESTOSTERONE LEVELS WILL BE MEASURED. IF RESPONSE IS OPTIMUM, THEN IT WILL BE CONTINUED FOR AT LEAST 3 MONTHS FOR FINAL SEMEN ANALYSIS. IF RESPONSE IS SUBOPTIMUM, DOSE OF CLOMIPHENE CITRATE WILL BE INCREASED TO 50 MG DAILY.

Exclusion Criteria

THOSE WITH PRIMARY SPERMATOGONIC FAILURE; THOSE WITH HERNIA, HYDROCOELE, KNOWN VARICOCOELE, PAST HISTORY OF EPIDIDYMO-ORCHITIS; THOSE SHOWING INADEQUATE RESPONSE TO 2 WEEKS OF CLOMIPHENE CITRATE 50 DAILY TAKEN FOR AT LEAST 2 WEEKS.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
CHANGES IN DIFFERENT SEMEN PARAMETERS- NAMELY, VOLUME,CONCENTRATION, MOTILITY, RAPID PROGRESSIVE MOTILITY, HOS TEST (HYPO-OSMOTIC SWELLING TEST),MORPHOLOGY, DNA- INTEGRITY TEST (BY ACRIDINE ORANGE STAINING TEST)Timepoint: CHANGES IN DIFFERENT SEMEN PARAMETERS AFTER 3 MONTHS OF TREATMENT
Secondary Outcome Measures
NameTimeMethod
ANY COUPLE SPONTANEOUSLY CONCEIVING WHILE THE HUSBAND IS ON TREATMENT WITHIN THE STIPULATED 3 MONTHS TIME PERIOD.Timepoint: 3 MONTHS.
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