Trials / Terminated
TerminatedNCT02605070
Pilot Study on the Effects of FSH Treatment on the Epigenetic Characteristics of Spermatozoa in Infertile Patients With Severe Oligozoospermia
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Instituto de Investigacion Sanitaria La Fe · Academic / Other
- Sex
- Male
- Age
- 25 Years – 45 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bravelle | 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. |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2017-06-13
- Completion
- 2017-06-13
- First posted
- 2015-11-16
- Last updated
- 2018-03-02
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT02605070. Inclusion in this directory is not an endorsement.