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Male Infertility clinical trials

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NCT ID: NCT01304927 Completed - Male Infertility Clinical Trials

Vitamin D Supplementation and Male Infertility: The CBG-study a Randomized Clinical Trial

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

Today, it is evident that vitamin D (VD) has more widespread effects than the classical actions related to bone mineralization and calcium homeostasis1. VD deficiency results in impaired reproductive performance in various species of animals, and recently the investigators have shown that the VD receptor (VDR), activating (CYP2R1, CYP27A1, CYP27B1) and inactivating (CYP24A1) enzymes are expressed in the human testis, epididymis, seminal vesicle, prostate and spermatozoa. Our following functional studies showed that VD increases intracellular calcium in mature spermatozoa, and hence may be important not only for spermatogenesis but also for sperm maturation. A new, and yet unpublished cross sectional study of 300 young healthy Danish men showed that men with lower levels of serum VD have significantly lower number of normally developed and motile spermatozoa. Hitherto, most cases of male infertility have been classified as "idiopathic", and infertile couples have been referred to symptomatic treatment at infertility clinics. These fertility treatments are often physically demanding for the female partner as well as expensive for the health care system. Any treatment that might improve semen quality of involuntary infertile men would be beneficial both for the infertile couples and the society in general. Our findings that VD may play a role for human semen quality have not yet been tested clinically. However, if VD supplementation proves efficient this opens for the first time for a causal, safe and cheap treatment of at least some cases of "idiopathic" impaired semen quality. The investigators believe our new human data supported by the results from the VD deficient and VDR KO animal studies and the high proportion of VD deficient Danish men provide sufficient evidence to initiate a randomized clinical trial of VD supplementation to infertile men. Infertile men have also have unfavorable altered levels of sex hormones and higher mortality than fertile men. Since VD deficiency is associated with increased mortality, regulation of aromatase, immune system, bone metabolism, glucose metabolism, cardiovascular system etc. our suggested clinical trial may also be able to evaluate several secondary endpoints in addition to the potential effect on semen quality.

NCT ID: NCT01232465 Completed - Male Infertility Clinical Trials

Impact of Sperm DNA Integrity on In Vitro Cycles

TBA on IVF
Start date: October 2010
Phase: N/A
Study type: Observational

Sperm DNA integrity will be measured via the Toluidine Blue Assay (TBA) for patients undergoing In Vitro Fertilization (IVF); the study will determine correlations, if any, between IVF success and sperm DNA integrity.

NCT ID: NCT00975117 Completed - Male Infertility Clinical Trials

Spermotrend in the Treatment of Male Infertility

Start date: September 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether the administration of the dietary supplement Spermotrend improves spermatogenesis parameters in subjects with male infertility unrelated to major testicular conditions. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of males with infertility to be recruited and randomized for the study is 86.

NCT ID: NCT00756561 Completed - Healthy Clinical Trials

HOP-2A - Intratesticular Hormone Levels

HOP-2A
Start date: September 2008
Phase: N/A
Study type: Observational

The purpose of this investigational study is to find out what hormones are present in healthy male testicles using fine needle aspiration.

NCT ID: NCT00596739 Completed - Male Infertility Clinical Trials

A Study of the Pre- and Post-operative Semen Analyses and Reproductive Hormone Levels of Men Undergoing Weight-reduction Surgery

Start date: November 2007
Phase: N/A
Study type: Observational

A correlation between obesity and male fertility has been observed in a few clinical studies. Normal weight men appear to have higher sperm concentrations and sperm motility when compared to obese men, suggesting that weight loss might improve sperm function. However, there also are reported cases of severe male factor infertility following weight loss surgery in previously fertile men. The aim of this study is to determine if there are differences in the semen analyses and hormone levels of men obtained before and after undergoing weight loss (bariatric) surgery. This will direct future research and treatment.

NCT ID: NCT00548977 Completed - Male Infertility Clinical Trials

Genetic Studies Spermatogenic Failure

Start date: January 2001
Phase: N/A
Study type: Observational

The proposed study is designed to test the following hypotheses: 1. Mouse autosomal or X-linked genes which are exclusively expressed in mouse spermatogonia are also spermatogonia-specific in human. 2. Severe spermatogenic defect, especially hypospermatogenesis or SCOS, is caused by an intrinsic defect in germ line stem cell or speramtogenia. 3. Spermatogonia-specific genes are caudate genes for human spermatogenic defect, especially for hypospermatogenesis or SCOS. 4. For a significant fraction of cases with severe spermatogenic defect, the sterile genes are transmitted via multifactorial inheritance mode. 5. For some cases with severe spermatogenic defect, mutations of spermatogonia- specific genes may be transmitted in the X-linked recessive, autosomal recessive, or autosomal dominant mode.

NCT ID: NCT00481403 Completed - Male Infertility Clinical Trials

Study of Sperm Molecular Factors Implicated in Male Fertility

Start date: May 2006
Phase:
Study type: Observational

Sperm analysis following World Health Organization guidelines is unable to explain the molecular causes of male infertility when basic sperm parameters are within a normal range and women do not present gynaecological pathology. Subsequently, there is a need for accurate diagnostic tools in this sense and microarray technology applied to sperm analysis emerges as a promising field

NCT ID: NCT00341120 Completed - Male Infertility Clinical Trials

Genetic Causes of Male Infertility

Start date: January 2, 2003
Phase:
Study type: Observational

This study is being conducted at the University Hospital of Lund University in Malmo, Sweden, in collaboration with the U.S. National Institute of Child Health and Human Development. The study will try to identify genetic causes of impaired sperm production and male infertility. It will focus on the possible role of the MTHFR and CBS genes, which regulate absorption and metabolism of the vitamin, folate in infertility. If the nutritional intake or metabolism of this vitamin is related to male infertility, then this cause of infertility would be potentially curable. Fertile and infertile men between 20 and 45 years of age may be eligible for this study. Criteria include the following: - Fertile men: men whose partners are younger than age 40 and are attending Lund University prenatal clinic; who have fathered one or more pregnancies and who stopped birth control to achieve the present pregnancy; who achieved the present pregnancy in less than 12 months of unprotected intercourse. - Infertile men: men referred to the Scandian Andrology Centre whose infertility is unexplained, whose partners are younger than age 40 and who have had regular sexual intercourse without contraception for at least 12 months without achieving a pregnancy. All participants will have the following tests and procedures: - Complete a questionnaire providing information about their reproductive and medical history and recent dietary history; - Provide blood samples for analysis of red cell folate, plasma folate, plasma homocysteine, plasma B12, and for genetic evaluation; - Provide a semen sample for routine analysis, including volume, sperm concentration, sperm motility, and sperm morphology. In addition, infertile men will undergo a physical examination and review of their medical records.

NCT ID: NCT00315029 Completed - Pregnancy Clinical Trials

Patient-Centered Implementation Trial for Single Embryo Transfer

Start date: November 2006
Phase: N/A
Study type: Interventional

Background: The number of multiple pregnancies is considered to be the most important adverse effect of in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI). IVF or ICSI with transferring only one embryo, elective single embryo transfer (eSET), will reduce this incidence remarkably. Unfortunately, former research has documented that cycles with SET maintain lower pregnancy rates compared to double embryo transfer (DET). Implementation of eSET will require a carefully chosen and thoroughly defined implementation strategy focussed on the couple undergoing the subfertility treatment. This trial will investigate the (cost)effectiveness of a combined patient centred implementation strategy. Objective: The main aim is to compare the effectiveness and costs of implementation of elective single embryo transfer (eSET) in in vitro fertilisation (IVF) and intracytoplasmic sperm injection (ICSI), between usual care and a combined patient-centred strategy. Study design: A randomised controlled trial Study population: Couples with a female age less than 40 years ongoing an IVF/ICSI treatment in 2 of the 13 Dutch IVF centres and their 4 satellite/transport centres. Intervention A combined patient centred implementation strategy for eSET in IVF/ICSI. The strategy consists of counselling through an evidence based decision aid and reimbursement of a 4th cycle if couples have chosen for eSET in the first 2 cycles. Primary study parameters/outcome of the study: the eSET occurrence rate, pregnancy outcomes and cost-effectiveness of the combined strategy. Secondary study parameters/outcome of the study: - patient knowledge - patient decisional conflict - patient satisfaction - IVF/ICSI treatment outcome.

NCT ID: NCT00178516 Completed - Male Infertility Clinical Trials

Vitamin E and Male Infertility

Start date: June 2004
Phase: N/A
Study type: Observational

The goal of this study is to determine whether there is a correlation between the levels of Vitamin E in sperm and sperm DNA fragmentation. Previous research has shown that damage to the DNA in sperm may cause infertility or increase the chances of miscarriage, if the damage is extensive (eg. present in the overwhelming majority of sperm). Some studies suggest that DNA damage can be caused by oxidative stress. Antioxidants, such as Vitamin E, which are present in some foods, can prevent damage to cells from "free radicals", which are naturally present by-products of metabolism. We ask whether there is a correlation between sperm DNA damage and Vitamin E