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. ]
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