Clinical Trial: Pilot Study on the Effects of FSH Treatment on the Epigenetic Characteristics of Spermatozoa in Infertile Patients With Severe Oligozoospermia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Pilot Study on the Effects of FSH Treatment on the Epigenetic Characteristics of Spermatozoa in Infertile Patients With Severe Oligozoospermia

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 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.

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.

Sponsor: Instituto de Investigacion Sanitaria La Fe

Current Primary Outcome: Epigenetic modification [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To assess the main characteristics of the spermiograms of infertility patients before and after FSH treatment. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 6-7 weeks after transfer of the embryo. ]
    To analyze the results of assisted reproduction treatments in patients receiving FSH treatment.


Original Secondary Outcome: Same as current

Information By: Instituto de Investigacion Sanitaria La Fe

Dates:
Date Received: November 9, 2015
Date Started: November 2015
Date Completion: January 2017
Last Updated: September 7, 2016
Last Verified: May 2016