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Feasibility of diet and exercise as a treatment option for men with abnormal semen analysis who desire fertility.

Feasibility of lifestyle intervention in men with abnormal semen analysis who desire fertility: a pilot randomized controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050436
Enrollment
60
Registered
2023-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: N461- Oligospermia Health Condition 3: N468- Other male infertility

Interventions

Intervention1: Lifestyle intervention: Customized advice on diet and physical exercise will be given.Those engaged in sedantary / less physical activity will be advised to walk for at least 30 minutes

Sponsors

Christian Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Men with idiopathic oligozoospermia or/and asthenozoopsermia or oligoathenozoopspermia or oligoasthenozooteratozoospermia. Age >21 years and

Exclusion criteria

Exclusion criteria: 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 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

Design outcomes

Primary

MeasureTime frame
Number of participants completing the intervention (dropout rate)Timepoint: At the end of six months

Secondary

MeasureTime frame
Noncompliance rate Improvement in semen parameters Reason (s) for refusal to participate in the trial Reason (s) for refusal to be randomized after initially agreeing to participate in the trial Reason (s) for drop out (discontinuation of the lifestyle intervention i.e. customized diet / exercise advise) Reason (s) for noncompliance to the lifestyle intervention i.e. customized diet/exercise Improvement in DNA Fragmentation Index Biomarker level (Total plasma antioxidant capacity) Clinical pregnancy rate (per couple) Miscarriage rate (per couple) Timepoint: At the end of six months

Countries

India

Contacts

Public ContactDr Mohan S Kamath

Christian Medical College and Hospital

mohankamath@cmcvellore.ac.in9994497690

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026