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Infertility, Male clinical trials

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NCT ID: NCT06358794 Completed - Infertility, Male Clinical Trials

Machine Learning Based-Personalized Prediction of Sperm Retrieval Success Rate

Start date: June 1, 2022
Phase:
Study type: Observational

Non-obstructive azoospermia (NOA) stands as the most severe form of male infertility. However, due to the diverse nature of testis focal spermatogenesis in NOA patients, accurately assessing the sperm retrieval rate (SRR) becomes challenging. The current study aims to develop and validate a noninvasive evaluation system based on machine learning, which can effectively estimate the SRR for NOA patients. In single-center investigation, NOA patients who underwent microdissection testicular sperm extraction (micro-TESE) were enrolled: (1) 2,438 patients from January 2016 to December 2022, and (2) 174 patients from January 2023 to May 2023 (as an additional validation cohort). The clinical features of participants were used to train, test and validate the machine learning models. Various evaluation metrics including area under the ROC (AUC), accuracy, etc. were used to evaluate the predictive performance of 8 machine learning models.

NCT ID: NCT06161727 Completed - Clinical trials for Human Papilloma Virus

Detection and Prevalence of Human Papillomavirus (HPV) in Seminal Plasma and/or on Sperm in Men Undergoing Treatment With IVF/ICSI.

Start date: January 1, 2023
Phase:
Study type: Observational

This observational study aims to investigate the presence of HPV DNA in semen samples from men undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment. It focuses on understanding the impact of HPV on male fertility and embryo development following IVF/ICSI. The primary goal is to determine the prevalence of HPV-positive (HPV+) semen samples among men seeking infertility treatment with IVF/ICSI. Additionally, the study aims to compare semen characteristics between HPV-positive and HPV-negative (HPV-) samples and assess the embryological outcomes after IVF/ICSI in these two groups. Participants in this study will include men receiving IVF/ICSI treatment and providing fresh ejaculated sperm at Sahlgrenska University Hospital in Gothenburg, Sweden, over one year. Those undergoing treatments with surgically extracted sperm, sperm freezing for fertility preservation, or planning treatments involving preimplantation genetic testing or egg donation will be excluded. The study will involve analyzing HPV DNA in semen samples through PCR, utilizing the most effective method for HPV DNA detection previously identified in a pilot study. Sperm samples collected during infertility investigations and IVF/ICSI treatments will undergo gradient centrifugation to separate different components. A portion of the sperm sample will be preserved for PCR analysis to detect HPV DNA, while the rest will be used for IVF/ICSI procedures. The results from the PCR analyses will be correlated with semen characteristics and the outcomes of IVF/ICSI treatment. Furthermore, the samples will be stored for potential future analyses related to HPV-related biomarkers for up to 5 years at Biobank.

NCT ID: NCT06042738 Completed - Male Infertility Clinical Trials

Investigation of The Effectiveness of Antioxidant Therapy in Oligoasthenoteratozoospermic Infertile Men

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

Approximately 30% of the factors that cause male infertility are due to idiopathic causes. Increased reactive oxygen species (ROS) due to many known and unknown factors cause male infertility by affecting spermatogenesis and sperm maturation. In this study, the effects of physical activity and antioxidant food supplementation on seminal antioxidant capacity, sperm DNA fragmentation index, sperm chromatin quality and sperm parameters were investigated in infertile cases.

NCT ID: NCT05919186 Completed - Infertility, Female Clinical Trials

Effects of Antioxidant Supplementation of Culture Media on IVF Embryos

Start date: October 12, 2021
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the impact of repeated antioxidant supplementation on blastocyst utilization and expansion rates in embryos under different oxygen concentrations. The study aims to answer the following main questions: - Does adding antioxidants every 12 hours to embryo culture media improve usable and expanded blastocyst utilization rates on days 5 and 6? - How are the O2 concentrations related to the effect of different methods of antioxidants supplementation on blastocysts utilization and expansion rates? Participants in this study are infertile couples undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycles. - Zygotes will be incubated at either 5% or 20% oxygen tension until the blastocyst stage. - Sibling zygotes will be divided into four groups: Group 1A and 1B: Antioxidants every 12 hours at either 5% or 20% O2 tension, respectively. Group 2A and 2B: Antioxidants only once at the beginning of embryo culture at either 5% or 20% O2 tension, respectively. Researchers will compare the four groups to determine if the repeated antioxidant supplementation of the culture media leads to improved blastocyst utilization and expansion rates compared to the baseline group.

NCT ID: NCT05894356 Completed - Infertility, Male Clinical Trials

The Paternal Clock: Uncovering the Consequences of Advanced Paternal Age on Sperm DNA Fragmentation

Paternal Clock
Start date: June 10, 2023
Phase:
Study type: Observational

Sperm DNA fragmentation (SDF) serves as a marker for chromatin and DNA damage in sperm. Assessing sperm DNA integrity is crucial in male fertility evaluation since high levels of SDF are associated with a greater number of adverse reproductive outcomes, including an increased risk of miscarriage and birth defects. Recent research suggests that advanced paternal age (APA) may lead to DNA damage in sperm, however the precise age at which this risk becomes apparent has not yet been clearly defined, necessitating the identification of the point in time at which high SDF levels occur. With the help of this knowledge, male infertility can be diagnosed with greater accuracy, and infertile couples can receive appropriate care.

NCT ID: NCT05847257 Completed - Infertility, Male Clinical Trials

Impact of Co Enzyme Q10 as Adjuvant Therapy to Letrozole on Spermiogram

Start date: December 1, 2021
Phase: Phase 2
Study type: Interventional

Worldwide infertility affects about 15 % of reproductive-age couples. In many cases, infertility can't be treated, new treatment options with promising value were involved in the recent clinical trials.

NCT ID: NCT05724979 Completed - Infertility, Male Clinical Trials

Outcome of Using Sperm Bound to the Zona Pellucida of Immature Oocytes for Intracytoplasmic Sperm Injection (ICSI)

Start date: March 5, 2021
Phase: N/A
Study type: Interventional

In vivo, the zona pellucida (ZP) of the oocyte can bind to normally functional sperm. The ZP-sperm interaction is one of the final steps of natural selection during their journey in the female reproductive tract. In the current study, we evaluated the ability of the ZP of immature oocytes to harvest the fittest sperm. We compared the embryological outcomes of intracytoplasmic sperm injection (ICSI) using conventionally selected sperm (control group) and ZP-bound sperm (intervention group). Our results showed no statistically significant superiority for the ZP binding technique over the conventional sperm selection with respect to the rates of fertilization and cleavage. However; the rates of blastocyst formation and high-quality blastocysts were significantly improved in the intervention group compare to the control group. These findings imply that the proposed technique can serve as a cost-effective and natural sperm selection method that has the potential to enhance the embryological and clinical outcomes of intracytoplasmic sperm injection (ICSI).

NCT ID: NCT05616598 Completed - Male Infertility Clinical Trials

Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters

Start date: March 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Hepatitis C virus is commona viral infection. Direct-acting antiviral (DAA) oral drugs has been used in treatment of HCVs. the effect of these drugs on male infertility is still under investigation.

NCT ID: NCT05461079 Completed - Infertility, Male Clinical Trials

Sperm Phenotype and Differentially Methylated Regions

Epigenetics
Start date: November 1, 2017
Phase:
Study type: Observational

Testicular dysgenesis syndrome (TDS) is known to cause epigenetic abnormalities in spermatozoa. Anogenital distance (AGD) is considered to be a suitable clinical marker of TDS, but the direct link between AGD and epigenetic abnormalities is still missing. Infertile men (n=10) presenting with shortened AGD and a control group of normal semen donors (n=10) with normal AGD will then be asked to provide one semen sample each. Using a flow cytometer and sorter (FACS) their spermatozoa will be sorted into populations of spermatozoa with/without DNA fragmentation or with/without chromatin decondensation. These sorted populations of spermatozoa will then be examined for differences in epigenetic imprinting differences using whole genome expression analysis. Whereas the sorting of spermatozoa will be carried out in Basel, the epigenetic analysis will be carried at the University of Geneva.

NCT ID: NCT05397314 Completed - Infertility, Male Clinical Trials

DNA Fragmentation - Effect on Pregnancy Rate

Start date: January 1, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether Punalpin, an antioxidant, has a positive impact on DNA fragmentation in spermatozoa in male fertility patients with increased amount of DNA fragmentation in their spermatozoa. Secondary purpose is to investigate whether there is any positive effect on the subsequent pregnancy rates from the fertility treatment.