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

Phase 3

Terminated

• Conditions: Male Infertility
• Interventions: Drug: Bravelle

• Registration Number: NCT02605070
• Lead Sponsor: Instituto de Investigacion Sanitaria La Fe

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-09
• Study First Submitted QC: 2015-11-11
• Study First Posted: 2015-11-16
• Status Verified: 2017-05
• Primary Completion: 2017-06-13
• Study Completion: 2017-06-13
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infertility group	Bravelle	Patients referred will be evaluated to participate in the study and then asked to take part.In this visit,the normal protocol for infertility patients will be followed and at least 2 spermiograms and a blood test analyzing the following parameters:FSH, LH,Estradiol,Total testosterone,SHBG, Albumin,Calculation of bioavailable testosterone,Prolactin.If these tests have not been performed,a second baseline visit will be scheduled.Should the patient meet all the inclusion criteria and after the patient has signed an informed consent form agreeing to participate in the study,the physician will prescribe the medication and schedule visits.Before initiating the treatment, they will provide a semen sample.This sample will be sent to the Center for Reproductive Biology,where the sample will be subjected to epigenetic analysis.The patient will be given samples of Bravelle.It is administered subcutaneously.The dose will be 150 IU 3times a week for 3months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hospital Universitari i Politècnic La Fe; 🇪🇸 Valencia, Spain