APO - Novel Approach for Oligospermia

Phase 1

• Conditions: Male infertility; Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]

• Registration Number: CTIS2023-508325-27-00
• Lead Sponsor: Herlev Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-20
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Infertile men >18 years and <60 years of age with reduced sperm production (Sperm concentration <2 mio/mL) - Serum AMH > 30 pmol/

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), Latex allergy, Any case with indication for testis biopsy, Serum FSH <3 IU/L, BMI >35 kg/m^2, Men with active or previous malignant disease, Sperm cell concentration <0.01 mio/mL, 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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this intervention is to investigate whether Denosumab can improve semen quality in a subgroup of infertile men.;Secondary Objective: Differences in clinical pregnancies, reproductive hormones, and differences in semen quality;Primary end point(s): Difference in sperm cell concentration (sperm cell concentration millions/mL) between the two groups, evaluted by the semen sample delivered at day 80

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Difference in semen quality between the intervention group and the placebo group (total number of sperm cells, and total and percentage of motile, progressive motile and morphological normal sperm cells), evaluated by semen sample delivered at day 80 compared with baseline;Secondary end point(s):Difference in spontaneous pregnancies before day 180;Secondary end point(s):Difference in number of spontaneous abortions during the whole trial;Secondary end point(s):Difference in serum levels of reproductive hormones (FSH, LH, AMH, Inhibin B) at day 80;Secondary end point(s):Changes in serum levels of reproductive hormones (FSH, LH, AMH, Inhibin B) at day 80 within the groups