Study, with random assignment of treatment, to assess whether different durations and different u-FSH medication dosages produce different results in treating male infertility

Phase 1

• Conditions: Male infertility; MedDRA version: 20.0Level: LLTClassification code 10065945Term: Male sterilitySystem Organ Class: 100000004872; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2016-004034-14-IT
• Lead Sponsor: AZIENDA OSPEDALIERA DI PADOVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-01
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 172

Inclusion Criteria

- Age between 20 and 50 years
- Caucasian Ethnicity
- Oligozoospermia (total sperm count <39 mil / ejaculate)
- Plasma FSH values <8 IU / L
- Normal plasma levels of LH and T
- Normal female fertility and age <40 years.
- Provision of the written informed consent to participation in the study
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 172
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Azoospermia
- Endocrine Disorders
- Genetic causes of infertility (chromosomal, microdeletions Cr. Y, CFTR mutations)
- Varicocele, cryptorchidism, infections, presence of antisperm antibodies, obstruction of the seminal ducts
- FSH = 8 IU / L
- Hypogonadism
- Systemic Diseases, testicular tumors
- Known causes of infertility in the partner with obstruction / absence of the tube, endocrine abnormalities, endometriosis, PCOS, oligo-amenorrhea, age = 40 years

Study & Design

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