Male Infertility
Conditions
Brief summary
Single center, prospective, open clinical study to determine the genomic imprint (epigenetic modification) in a series of male infertility patients with alterations in their spermiogram (oligozoospermia) compared to a group of fertile patients in order to evaluate the effect of FSH ( follicle stimulating hormone) administration on these modifications and on male infertility.
Detailed description
Single center, prospective, open clinical study to determine the genomic imprint (epigenetic modification) in a series of male infertility patients with alterations in their spermiogram (oligozoospermia) compared to a group of fertile patients in order to evaluate the effect of FSH ( follicle stimulating hormone) administration on these modifications and on male infertility. Main objective: To determine the genomic imprint (epigenetic modification) in a series of male infertility patients with alterations in their spermiogram (oligozoospermia) compared to a group of fertile patients in order to evaluate the effect of FSH administration on these modifications and on male infertility. Secondary objectives * To assess the main characteristics of the spermiograms of infertility patients before and after FSH treatment. * To assess modifications in the hormones involved in sperm formation in infertility patients before and after treatment. * To analyze the results of assisted reproduction treatments in patients receiving FSH treatment.
Interventions
DRUGBravelle
Bravelle will be provided to all patients in the treatment group by the principal investigator (PI) or another member of the research team. From week nine on, the patients will undergo a physical examination on three different occasions to assess the appearance of any adverse reactions during treatment. It will be up to the patient to communicate the appearance of signs or symptoms which could be associated with the use of the drug. At week 12 the patient will be scheduled for another visit to perform a semen study and to measure new hormone levels. To this end, a blood test will be carried out (FSH, LH, estradiol, total testosterone, SHBG, and albumin to calculate the amount of bioavailable testosterone). A semen sample will also be obtained to carry out a spermiogram according to WHO guidelines; part of this sample will be used for epigenetic analysis.
Sponsors
Instituto de Investigacion Sanitaria La Fe
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
25 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Inclusion criteria for the infertility treatment group (n=30) 1. Between 25-45 years of age. 2. Total sperm concentration (concentration in millions/mL x volume in mL) between 1-10 million (oligozoospermia) in at least 2 spermiograms obtained after a 2-4 day period of sexual abstinence and with a 7-day separation period between tests. 3. Caucasian. 4. Inability of the couple to become pregnant after one year of sexual relations without using any type of contraception. 5. FSH 2-12 IU/mL. 6. Total testosterone \>300 ng/mL and bioavailable testosterone (calculated with the Sexual Hormone Binding Globulin or SHBG albumin) \>145 ng/dL. * Inclusion criteria for the control group of fertile males (n=15) 1. Between 25-45 years of age. 2. Caucasian. 3. Sperm concentration and motility above the 5th percentile according to the parameters set forth in the 5th edition of the World Health Organization (WHO) guidelines in at least two spermiograms obtained after a 2-4 day period of sexual abstinence and with a 7-day period between tests. 4. Seminal volume \>1 mL. 5. Estradiol \<50 pg/mL 6. FSH \<4.5 IU/L. 7. Total testosterone \>300 ng/dL and bioavailable testosterone \>145 ng/dL. 8. No vasectomy. 9. Has sired a child within the past 5 years. *
Exclusion criteria
for the infertility treatment group. 1. Total sperm concentration \<1 million. 2. Sperm motility of 0%. 3. History of cryptorchidism, malignant or benign tumors, known chromosomal abnormalities, testicular tor- sion, testicular trauma, orchitis. 4. Drug use in the past 120 days. thyroid dysfunction 5. Medical history:thyroid dysfunction, blood disease, diabetes. 6. Use of anabolic steroids in the past 2 years or for more than 2 years. 7. Body mass index \>30 kg/m . 8. Intake of over 21 units of alcohol/week in the past 120 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Epigenetic modification | 12 weeks after treatment. | To determine the genomic imprint (epigenetic modification) in a series of male infertility patients with alterations in their spermiogram (oligozoospermia) compared to a group of fertile patients in order to evaluate the effect of FSH administration on these modifications and on male infertility |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess the main characteristics of the spermiograms of infertility patients before and after FSH treatment. | First week and end of treatment visit (12 weeks). | To assess the main characteristics of the spermiograms of infertility patients before and after FSH treatment. |
| To assess modifications in the hormones involved in sperm formation in infertility patients before and after treatment. | First week and end of treatment visit (12 weeks) | To assess modifications in the hormones involved in sperm formation in infertility patients before and after treatment. |
| Pregnancy rate. | 6-7 weeks after transfer of the embryo. | To analyze the results of assisted reproduction treatments in patients receiving FSH treatment. |
Countries
Spain
Outcome results
None listed