Vitamin D supplementation in infertile males with decreased sperm count and motility.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/09/009678
• Date of registration: 07-09-2017
• Prospective Registration: No
• Primary sponsor: ESI PGIMSR
• Public title: Vitamin D supplementation in infertile males with decreased sperm count and motility.
• Scientific title: IMPACT OF VITAMIN D SUPPLEMENTATION ON SEMEN QUALITY IN VITAMIN D DEFICIENT INFERTILE MALES WITH OLIGOASTHENOZOOSPERMIA
• Date of first enrolment: 01-11-2016
• Target sample size: 30
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19384
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Srishti Priyadarshini
• Affiliation: Employee State Insurance-Post Graduate Institute of Medical Science and Research

• Name: Dr Srishti Priyadarshini
• Affiliation: Employee State Insurance-Post Graduate Institute of Medical Science and Research

Key inclusion & exclusion criteria

Inclusion criteria: 1) Infertile males meeting the WHO criteria for oligospermia or asthenozoospermia, i.e. sperm concentration <15 million/ml and/or progressive sperm motility <32%.

2) Males asymptomatic for vitamin D deficiency.


Exclusion criteria: 1) Men with history of any chronic illness, endocrine or metabolic disorders or malignancy.

2) History of intake of vitamin D for preceding 3 months.

3) History of testicular infection, testicular mumps, cryptorchidism, varicocelectomy, testicular biopsy.

4) Males with vitamin D level > 30 ng/ml

5) Males with azoospermia.



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Infertility

Intervention(s)

Intervention1: Vitamin D supplementation: 60,000 IU cholecalciferol once weekly for 3 months.
Control Intervention1: NIL: NIL

Primary Outcome(s)

1) Semen parameters- sperm concentration, sperm motilityTimepoint: 3 months

Secondary Outcome(s)

) Levels of reproductive hormone profile- FSH, LH, Testosterone, Estradiol.

2) Levels of bone regulating hormones- Alkaline phosphatase, serum calcium, serum phosphate.

3) Effect on pregnancy outcomes

Timepoint: 6 months

Secondary ID(s)

NIL

Source(s) of Monetary Support

ESI PGIMSR Basaidarapur Ring Road Delhi-110015

Ethics review

Status: Approved
Approval date: 08/10/2016
Contact:

Institutional Ethical Committee ESI-PGIMSR Hospital Complex