Clinical trial NCT02605070: Pilot Study on the Effects of FSH Treatment on the Epigenetic Characteristics of Spermatozoa in Infertile Patients With Severe Oligozoospermia
Official title: Pilot Study on the Effects of FSH Treatment on the Epigenetic Characteristics of Spermatozoa in Infertile Patients With Severe Oligozoospermia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Male Infertility
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 30
Sex: MALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Epigenetic modification
timeFrame: 12 weeks after treatment.
Secondary outcomes:
measure: To assess the main characteristics of the spermiograms of infertility patients before and after FSH treatment.
timeFrame: First week and end of treatment visit (12 weeks).
measure: To assess modifications in the hormones involved in sperm formation in infertility patients before and after treatment.
timeFrame: First week and end of treatment visit (12 weeks)
measure: Pregnancy rate.
timeFrame: 6-7 weeks after transfer of the embryo.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
Study officials:
References:
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