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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT02422108
Eligibility Criteria:
Infertile men referred for evaluation of male infertility at department of growth and reproduction or infertile men interested in participation in clinical trials.
Inclusion Criteria:
* Male with an age \> 18 years old
* Referred for male infertility with sperm concentration \>= 0.1 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 calcium homeostasis (such as inflammatory disease with granuloma: sarcoidoses, tuberculosis, Wegeners, vasculitis, inflammatory bowel disease (Crohn's and colitis ulcerosa etc).
* Men with previous testis cancer
* 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
* Serum Calcium ion \< 1,18 or \> 1,35 mmol/l
* Serum OPG \>4 pg/ml
* Serum PTH \<1.6 or \>6 pmol/l
* Inhibin-B \< 50 pg/ml
* Latex Allergy
* no good oral condition or major implants
* BMD \< -1,5 in columna lumbalis and collum femoris
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
* New treatment with diuretics, antihypertensive treatment, treatment the heart, calcium channel blockers
* If testis biopsy is performed or other surgery in the genital region during the trial
* Prolia Intoxication
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02422108
Study Brief:
Protocol Section:
NCT02422108