Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT01304927
Eligibility Criteria:
Inclusion Criteria:
* Male with an age \> 18 years old
* Referred for male infertility with sperm concentration \>= 0.01 million/ml. Additionally, all men must have either sperm concentration \< 20 million/ml or \< 50% progressive motile spermatozoa or \< 12% morphological normal spermatozoa using strict criteria
Exclusion Criteria:
* Men with chronic diseases (such as diabetes mellitus, Thyroid disease, endocrine disturbances in need of treatment, malignant disease, or diseases known to interfere with VD intake or very sensitive to VD intake (such as inflammatory disease with granuloma: sarcoidoses, tuberculosis, Wegeners, vasculitis, inflammatory bowel disease (Crohn's and colitis ulcerosa etc).
* Men with present or previous malignant disease
* If there is an indication for testis biopsy and it is planned or conducted within the next 6 months
* Serum 25-hydroxy-D3 \> 50 nmol/l at the time of inclusion
* Serum Calcium ion \> 1,35 mmol/l
* Inhibin-B \< 30 pg/ml
* Intake of vitamin D above 15 ug daily
* Allergy towards vitamin D or arachidis oil (peanuts)
* Men with total or partly obstructive oligospermia and men who had vasectomy performed
Criteria for drop out:
* Abrogation of the treatment
* Newly diagnosed endocrine, calcium metabolic disease, parathyroid, thyroid, diabetes or other endocrine disease in need of treatment
* New malignant disease
* Treatment with chemotherapy, immunomodulating therapy, salazopyrin
* Oral or iv treatment with steroid hormones
* Treatment with diuretics, antihypertensive treatment, treatment the heart, calcium channel blockers
* Development of vitamin d intoxication
* If testis biopsy is performed or other surgery in the genital region during the trial
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01304927
Study Brief:
Protocol Section:
NCT01304927