Male infertility MedDRA version: 18.0 Level: LLT Classification code 10017399 Term: FSH System Organ Class: 100000004848
Conditions
Interventions
Trade Name: FSH_IMEN
Product Name: BRAVELLE
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: D06269
CAS Number: 97048-13-0
Other descriptive name: UROFOLLITROPI
Sponsors
Instituto de Investigación Sanitaria La Fe
Eligibility
Sex/Gender
Male
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 after treatment with FSH. - Assess the modifications of the hormones involved in training sperm of infertile patients before and after treatment. - Analyze the outcome of assisted reproduction treatment in those patients 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Clinical pregnancy rate defined as the identification of at least one sack gestational fetal heartbeat on transvaginal ultrasound in week 6-7 after transfer embrión.- - FSH, LH, testosterone, bioavailable testosterone after treatment. - Count, concentration and mobility of sperm ejaculated after the treatmen;Timepoint(s) of evaluation of this end point: After treatment. | — |
Countries
Spain
Contacts
Public ContactUREC
INSTITUTO DE INVESTIGACION SANITARIA LA FE
Outcome results
None listed