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Infertility, Male clinical trials

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NCT ID: NCT02814695 Completed - Infertility, Male Clinical Trials

Yeast Cells as Antioxidant-Producing Probiotics

Probiotics
Start date: August 15, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the efficacy of Baker's yeast extractions , probiotic antioxidant, in scavenging the oxidative stress status mediated damage on sperm motility,progressive motility and vitality as well as comparing this potency to that of Vitamin E in infertile men.

NCT ID: NCT02756923 Completed - Male Infertility Clinical Trials

Regulation of Stem Spermatogonia in the Mature Testis

Start date: April 2012
Phase:
Study type: Observational

Investigative trial to evaluate the role of a glial cell lined derived neurotrophic factor (GDNF) in regulation of spermatogonial renewal and testicular function. Goal of the trial is to provide greater information on the mechanisms that effect stem spermatogonial maintenance renewal and proliferation in its relation to male infertility.

NCT ID: NCT02719093 Not yet recruiting - Infertility, Male Clinical Trials

Role of FSHR Polymorphism p.N680S in the Therapy With FSH in Patients Who Underwent Varicocele Surgery

Start date: July 2016
Phase: Phase 4
Study type: Interventional

Two common SNPs are located in linkage disequilibrium in exon 10 of FSHR. The 2039 A>G variant is regularly analyzed to characterize the exon 10 haplotype. In the last years, it has been showed an influence of FSHR 2039 A>G on FSH levels, testicular volume, sperm concentration and the total sperm count. A recent Cochrane review showed a beneficial effect on live birth and pregnancy of gonadotrophin treatment for men with idiopathic male factor subfertility. Which FSHR polymorphism can benefit from FSH treatment is clinically very important, in particular for what regards nonidiopathic patients. In many andrological units, patients underwent adiuvant therapy with purified or recombinant FSH after varicocelectomy. FSH treatment in patients after varicocelectomy could improve spermatogenesis, but there aren't multicentric trials that confirm its validity. Usually, in our hospital only patients with a morphologic aspect of hypospermatogenesis underwent therapy with purified or recombinant FSH, because this therapy is not much useful in patient with Partial Sertoli-cell-only syndrome or maturation arrest. The purpose of our study is to correlate "non responder" patients who underwent FSH adiuvant therapy after varicocele surgery with a p.N680S FSHR polymorphism. Moreover the investigators suppose that "non responder" patients can beneficiate from a high-dose therapy with FSH. This is a prospective intervention study in which are recruited males with OligoAstenoTeratozoospermic (OAT) and varicocele. The partecipants will undergo subinguinal microsurgical varicocelectomy (Marmar technique) and needle aspiration testicular cytology (Foresta technique).

NCT ID: NCT02641769 Recruiting - Clinical trials for Non-obstructive Azoospermia

Intra-Testicular Transplantation of Autologous Stem Cells for Treatment of Non-Obstructive Azoospermia Male Infertility.

Start date: January 2014
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open label, single arm, single center investigation to assess the safety and efficacy of purified adult autologous bone marrow derived CD34+, CD133+, and mesenchymal stem cells injected into the seminiferous tubules and testis, through a 12 week follow-up period. The investigators' selected model of research is based on maximizing the efficiency of the approach by choosing an autologous pattern which preserves the genetic make-up of an individual that is vital in infertility conditions. Additionally the approach involves injecting a combination of different but purified cell types which all aid in the retrieval of spermatogenesis, and the generation of mature spermatozoa. Expected outcomes of this study are defined in general improvements in infertile patients in regards of testicular morphology, sexual function, semen quality, development of primary or secondary spermatocytes, spermatids, or mature spermatozoa in the testis, seminiferous tubules, or semen.

NCT ID: NCT02605070 Terminated - Male Infertility Clinical Trials

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

Start date: November 2015
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT02575924 Recruiting - Embryo Development Clinical Trials

Influence of Culture Media on Clinical Outcomes in Poor Responders or Severe Male Infertility

Start date: June 2015
Phase: Phase 1
Study type: Interventional

In this study the suitability of two -sequential and single step- commercially available culture media from the same brand was compared. The aim of such study is to verify whether is possible to improve the efficiency of infertility treatments in those couples who usually have a high cycle cancellation rate, such as poor responder patients and severe male infertility. The study population is composed of couples attending the fertility clinic: to this purpose all those couples approaching IVF treatments with a diagnosis of OAT, cryptozoospermia, advanced maternal age and women with a "poor responder" diagnosis were recruited. IVF treatments were randomly set to be cultured either with two-step sequential media or with one-step media to acquire data concerning the ongoing embryo culture development and clinical outcomes.

NCT ID: NCT02527954 Terminated - Clinical trials for Male Sterility Due to Y-chromosome Deletions

Aneuploidies in Embryos and Spermatozoa From Patients With Y-chromosome Microdeletions

Start date: September 22, 2015
Phase:
Study type: Observational [Patient Registry]

In this study, investigators assess, using Fluorescence in situ Hybridization (FISH) and Comparative Genomic Hybridization (CGH) arrays for Preimplantation Genetic Screening (PGS), the incidence of aneuploidies in spermatozoa and embryos from infertile men with and without microdeletions who undergo assisted reproduction in their clinics.

NCT ID: NCT02475395 Completed - Sub-Fertility, Male Clinical Trials

Study of the Consumer Use of a New Home Test to Measure Sperm Concentration

Start date: September 2, 2015
Phase: N/A
Study type: Interventional

The objective of the study is to evaluate the agreement in measurement of sperm concentration in human semen between lay users with TRAK and a recognized reference method. The study will also include the measurement of matched samples by TRAK when tested by healthcare professionals trained in use of the TRAK device.

NCT ID: NCT02421887 Completed - Male Infertility Clinical Trials

Males, Antioxidants, and Infertility Trial

MOXI
Start date: December 2015
Phase: Phase 2
Study type: Interventional

The objective of the Males, Antioxidants, and Infertility (MOXI) Trial is to examine whether treatment of infertile males with an antioxidant formulation improves male fertility. The central hypothesis is that treatment of infertile males with antioxidants will improve sperm structure and function, resulting in higher fertilization rates and improved embryo development, leading to higher pregnancy and live birth rates. Findings from this research will be significant in that they will likely lead to an effective, non-hormonal treatment modality for male infertility. An effective treatment for men would also reduce the treatment burden on the female partner, lower costs, and provide effective alternatives to couples with religious or ethical contraindications to ART (Assisted Reproductive Technology). If antioxidants do not improve pregnancy rates, but do improve sperm motility and DNA integrity, they could allow for couples with male factor infertility to use less intensive therapies such as intrauterine insemination. Male fertility specialists currently prescribe antioxidants based on the limited data supporting their use. A negative finding, lack of any benefit, would also alter current treatment of infertile males.

NCT ID: NCT02349945 Completed - Male Infertility Clinical Trials

FSH Receptor Polymorphism p.N680S and Efficacy of FSH Therapy

Start date: January 2011
Phase: Phase 2/Phase 3
Study type: Interventional

CONDITION: Idiopathic male infertility In men with idiopathic infertility, the sperm DNA fragmentation index (DFI) within 12 weeks of FSH therapy and 12 weeks follow-up improves depending on the FSHR genotype as assessed by the non-synonymous SNP rs6166 (wild type or p.N680S). This is a phase II b, multicenter, prospective, open label, one arm, clinical trial stratified according to the patient's genotype. INTERVENTION: FSH therapy (150 I.U. sc every other day for 12 weeks) in infertile men who are homozygous for the wild-type FSHR or the p.N680S allele of the FSHR. Duration of intervention per patient: 12 weeks Primary efficacy endpoint: Sperm DFI. Number of patients with an improvement in DFI > 60% Key secondary endpoint(s): pregnancy, semen parameters, serum levels of inhibin B and AMH.