Study on the effect of FSH treatment in epigenetic sperm in infertile patients

• Conditions: Male infertility; MedDRA version: 18.0Level: LLTClassification code 10017399Term: FSHSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2015-002521-19-ES
• Lead Sponsor: Instituto de Investigación Sanitaria La Fe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-12
• Last Update Posted: 26 October 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1.Age 30-40 years
2. Total sperm concentration (concentration / mL million
x volume in ml) from 1-10 million (oligozoospermia) at least 2
Semen obtained with a period of sexual abstinence 2-4
days and at least a separation between 7 days.
3. Caucasian.
4. Inability of the couple to achieve a pregnancy after one year of
sex without using any birth control.
5. 2-12 FSH IU / mL.
6. Total Testosterone greater than 300 ng / mL and bioavailable testosterone,
calculated from albumin, Sex Hormone Binding Globuling -
SHBG- greater than 145 ng / dL
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 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Age between 30-40 years.
2. Caucasian.
3. Concentration and sperm motility above percentile
50 according to the parameters of the fifth edition of the Organization
World Health Organization (WHO) in at least two semen in the
least 2 semen obtained with a period of abstinence
sexual 2-4 days and at least a separation between 7 days.
4. increased seminal volume of 1 ml.
5. Estradiol less than 50 pg / mL
6. FSH less than 4.5 IU / L.
7. Total Testosterone greater than 300 ng / dL and bioavailable testosterone
greater than 145 ng / dL.
8. Have not been vasectomized.
9. Have been parents in the past five years.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Determine genomic imprinting (epigenetic modification) in a number of infertile male patients with alteration in their semen (oligozoospermia) against a group of fertile men, assessing the effect on these changes by administering FSH in the group with infertility;Secondary Objective: -Evaluate the main characteristics of semen of infertile patients before and<br>after treatment with FSH.<br>- Assess the modifications of the hormones involved in training<br>sperm of infertile patients before and after treatment.<br>- Analyze the outcome of assisted reproduction treatment in those patients<br>which they were administered FSH;Primary end point(s): Changes in methylation of sperm DNA or epigenetic changes detectable after treatment.;Timepoint(s) of evaluation of this end point: After 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Clinical pregnancy rate defined as the identification of at least one sack<br>gestational fetal heartbeat on transvaginal ultrasound in week 6-7 after<br>transfer embrión.-<br> - FSH, LH, testosterone, bioavailable testosterone after treatment.<br>- Count, concentration and mobility of sperm ejaculated after<br>the treatmen;Timepoint(s) of evaluation of this end point: After treatment.