Randomized, Placebo-Controlled, Double-Blind, Multi-Centre Pilot Study to Investigate the Effect of AM019016 on male spermatogenesis in Subjects with diagnosed unspecific (idiopathic) subfertility.
- Conditions
- unspecific subfertility in menchildlessness
- Registration Number
- DRKS00011616
- Lead Sponsor
- Active Bio Life Science GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- Male
- Target Recruitment
- 25
1. Men with existing unfulfilled child wish
2. Uspecific (idiopathic) subfertility diagnosed by an already existing sperm analysis (may not be older than four weeks) and whilst observing a sexual abstinence period of at least 2 days to a amaxium of 7 days; according to WHO reference values (2010, 5th Edition):
- < 39 million total number of spermatozoa per ejaculate sample and / or
- < 32 % progressive motile spermatozoa
4. Readiness to comply with at least 2 to a maximum of 7 Days of sexual abstinence before creating a Spermogram
5. Consent to take a dietary food for three months
A written consent of the subject after written and oral enlightenment by the doctor about nature, scope, importance, potential benefits and possible risks of the clinical trial is the prerequisite for participation in the clinical trial.
1. Presumed or established organic causes of subfertility
2. azoospermia, aspermia, anejaculation
3. Varicocele of the testis, assessment according to medical examination discretion
4. Urogenital infections such as e.g. Prostatitis, epididymitis, Orchitis, sexually transmitted diseases
5. Known relevant endocrine disorders, e.g.
Hypogonadotropic hypogonadism (assessment according to Medical discretion)
6. Operational interventions in the past:
- Orchidopexy in cryptorchid or hoddentorsion, varicocele surgery, hodentrauma, pelvine, inguinal or scrotal surgical procedures
- any surgical intervention during the last 6 months before the start of the study and planned interventions during the study
7. Systemic disorders that could influence the outcome of the study, assessment by medical judgment (e.g., diabetes, renal failure, hepatic impairment, malignancy, obesity)
8. Pesticide exposure in the past and present
9. Ingestion of substances or other forms of therapy that could influence the study result according to medical discretion, eg:
- Medication, e.g. Anabolic agents, sulfasalazines, alpha-blockers, cimetidine and aldosterone antagonists, androgens, 6 months before study initiation and during the study
- Regular intake of dietary supplements / supplementary balanced diets in the last 6 months before the start of the study and during the study (with the exception of the study preparation)
- Applied therapy to improve sperm quality in the last 6 months before the start of the study and during the study
- Application of antioxidants in the last 6 months before study start and during the study
10. Known intolerance / allergic reactions to the ingredients of the investigational medicinal product
11. Significant changes in the patient's lifestyle, especially regarding medication intake, diet, smoking, alcohol last month Study start and during the study
12. Drug, alcohol and / or drug abuse
13. Simultaneous participation in another clinical trial or participate in such an event within the last 30 days
14. Signs that the subject's is expected to fail test plan (E.g. lack of co-operation)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Parameters for the assessment of the benefit by preparation and evaluation of spermograms according to the WHO criteria (2010, 5th edition):<br> <br>Change in progressive motility (visit 1 vs. visit 2) <br>Change of sperm concentration (visit 1 vs. visit 2) Change of sperm morphology (visit 1 vs. Visite 2) Change of sperm total (Visite 1 vs. Visite 2) <br>Change in total motility (visit 1 vs. Visite 2) <br>Change of the ejaculate volume (visit 1 vs. Visite 2) <br>Occurrence of pregnancy during the study and about 3 months after visit 2 <br>Global evaluation of the benefit by the physician (to visit 2) on a scale with the four assessment points very good, good, moderate and bad.
- Secondary Outcome Measures
Name Time Method Parameters for the assessment of tolerability: <br>Adverse events and serious adverse advents during the clinical trial <br><br>Global evaluation of the tolerability by the physician and subjects using a scale with the four assessment points very good, good, moderate and bad at final visit.