Feasibility of diet and exercise as a treatment option for men with abnormal semen analysis who desire fertility.
- Conditions
- Health Condition 1: - Health Condition 2: N461- OligospermiaHealth Condition 3: N468- Other male infertility
- Registration Number
- CTRI/2023/03/050436
- Lead Sponsor
- Christian Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Men with idiopathic oligozoospermia or/and asthenozoopsermia or oligoathenozoopspermia or oligoasthenozooteratozoospermia.
Age >21 years and <40 years of age.
Men who are unable to come up for follow up.
Men from states other than Tamil Nadu, Karnataka, Kerala, Andhra Pradesh & Telangana
Men who smoke
Men with clinically palpable varicocoele
Men who are on drugs which are known to affect spermatogenesis
Men who are on antioxidants supplements within previous six months.
Men with azoospermia or cryptozoospermia
Men with sperm concentration of < 5 million/ml
Men with previous history of childhood mumps, gonadotoxic therapy or immunosuppressants intake.
Surgical history of orchidectomy/ other genitourinary surgery like varicocoelectomy, testicular torsion
Men with recent intake of alternative modalities of treatment (Ayurvedic/ Homeopathy within 6 months
GI conditions such as Ulcerative colitis, Crohns disease which have special dietary advice
Men with Diabetes mellitus, chronic renal disease, malignancy, sexually transmitted disease
Female partner with other known causes of infertility as below:
Severe endometriosis
Documented tubal bilateral pathology
Endometrial pathology such as Ashermanâ??s syndrome
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of participants completing the intervention (dropout rate)Timepoint: At the end of six months
- Secondary Outcome Measures
Name Time Method oncompliance rate <br/ ><br>Improvement in semen parameters <br/ ><br>Reason (s) for refusal to participate in the trial <br/ ><br>Reason (s) for refusal to be randomized after initially agreeing to participate in the trial <br/ ><br>Reason (s) for drop out (discontinuation of the lifestyle intervention i.e. customized diet / exercise advise) <br/ ><br>Reason (s) for noncompliance to the lifestyle intervention i.e. customized diet/exercise <br/ ><br>Improvement in DNA Fragmentation Index <br/ ><br>Biomarker level (Total plasma antioxidant capacity) <br/ ><br>Clinical pregnancy rate (per couple) <br/ ><br>Miscarriage rate (per couple) <br/ ><br>Timepoint: At the end of six months