FITMI - First In Treating Male Infertility

Phase 1

• Conditions: Male infertility; MedDRA version: 20.0Level: PTClassification code 10021929Term: Infertility maleSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2021-003451-42-DK
• Lead Sponsor: Dept. of Growth and Reproduction

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-28
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 282

Inclusion Criteria

- Infertile men >18 years and <60 years of age with reduced sperm production (Sperm concentration <20 mio/mL)
- Serum AMH > 38 pmol/L
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 282
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Men with chronic diseases (diabetes mellitus, thyroid disease, endocrine diseases requirering treatment such as sarcoidosis, tuberculosis, wegeners, vasculitis as well as inflammatory bowel diseases e.g. chron’s disease or ulcerative colitis etc).
- Men with active or previous malignant disease
- Men in treatment for osteoporosis
- Serum ionized calcium < 1,18 mmol/L, Total calcium < 2.14 mmol/L or Albumin corrected calcium <2.17 mmol/L
- Serum 25OHD < 25 nmol/L
- eGFR <60 mL/min/1.73m^2
- Poor dental status og dental implants
- Men with obstructive oligospermia (Sperm volume <0.9 mL) or who has been vasectomized
- Latex allergy
- Any case with indication for tesis biopsy,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified