Male Infertility

Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) to understand how different PET/CT scans can predict outcomes during radioligand therapy with 177Lu-PSMA-617. This is an exploratory, prospective study conducted at a single center, focusing on imaging tumor heterogeneity to help assess therapy effects and patient response. The study is designed specifically for Veterans undergoing this treatment. Participants will receive several types of PET/CT scans at different times: before starting LuPSMA radioligand therapy (RLT), and then after the 2nd, 4th, and 6th treatment cycles. These scans include 18F-Fluciclovine PET/CT (Axumin), 18F-DCFPyL PET/CT, and 18F-FDG PET/CT. The 18F-Fluciclovine scans will be performed within seven days of the PSMA PET scans to compare imaging results at each time point. During the study, detailed imaging measures such as lesion uptake and tumor volume will be collected and analyzed over time. Patients will be followed at the institution to correlate these imaging results with clinical outcomes. The main outcome measured is the impact of 18F-Fluciclovine PET/CT on predicting outcomes of the 177Lu-PSMA-617 therapy from enrollment through 34 weeks of treatment.

Researchers are evaluating the use of XYOSTED as a testosterone replacement therapy in adolescent males aged 12 to under 18 years with primary or secondary hypogonadism, a condition where the body produces little or no testosterone. This Phase 3/4 open-label study aims to assess how well XYOSTED supports the continuation or start of puberty, along with its safety and the testosterone levels it maintains. Participants will receive XYOSTED injections at doses tailored to their weight and targeted pubertal stage. Dose adjustments will be made based on testosterone levels measured at specific intervals after dosing, with evaluations approximately every three months to reach the desired hormone levels. After completing the 52-week initial study period, participants may enter a 24-month extension to further monitor long-term safety and treatment effects. Throughout the study and extension, participants will undergo clinical examinations including pubertal staging, blood tests for testosterone and other labs, bone density scans, body composition assessments, and X-rays to monitor bone age. Researchers will track changes in puberty progression, bone health, body measurements, and hormone levels. Participants will attend regular clinic visits every six months during the extension phase to continue safety and pharmacokinetic evaluations.

Researchers are studying the effects of the drug leflutrozole on semen quality in men aged 18 to 49 years with low testosterone levels. This phase 2 clinical trial aims to find out whether leflutrozole can improve semen quality and what side effects participants may experience compared to a placebo. The trial is sponsored by ReproNovo Aps and focuses on testicular function and hormone levels. Participants will be randomly assigned to receive one of three doses of leflutrozole (0.05 mg, 0.1 mg, or 0.3 mg) or a placebo. The medication is taken orally once a week for 16 weeks. The study is double-blind, meaning neither the participants nor the researchers know who receives the drug or placebo. Checkups and tests occur every 4 weeks during the treatment period. Men in the trial will provide semen samples to measure sperm count, motility, and other quality markers. Blood tests will monitor hormone levels such as testosterone and estradiol, as well as safety markers including prostate-specific antigen and ECG readings. Questionnaires will assess changes in libido and energy. Researchers will track adverse events throughout the 16 weeks to evaluate safety and effectiveness.

This research aims to compare the pharmacokinetics of SJ04, a biosimilar of Ovidrel4, in healthy Chinese female subjects aged 20 to 40 years. The study evaluates how similar the body processes these two recombinant human chorionic gonadotropin injections when given by subcutaneous injection. It is a randomized, open-label, single-dose, two-cycle, double-crossover trial involving healthy women to assess drug similarity and safety. Participants are randomly assigned to two groups: one receives SJ04 first followed by Ovidrel4 after a two-week washout period, and the other receives Ovidrel4 first followed by SJ04 after the same interval. Each injection is a single subcutaneous dose of 250 1g given once per cycle. The crossover design allows each subject to receive both treatments with a washout period in between. During the study, researchers monitor pharmacokinetic measures such as the area under the plasma concentration curve and peak plasma concentration on day 8 after dosing. They also track adverse events and immune responses. The trial involves screening, drug administration on specified days, and follow-up assessments to evaluate safety and drug behavior. Participation lasts through both cycles including the washout and observation periods.

This research aims to compare two oxygen concentration protocols—constant 5% versus sequential 5%-2%—used during embryo culture in assisted reproductive technology. The study focuses on women undergoing blastocyst transplantation to evaluate differences in term live birth rates and offspring health, including potential effects on telomere length, which is linked to aging and health outcomes. The trial is conducted across five centers, including the Clinical Center of Reproductive Medicine at the First Affiliated Hospital of Nanjing Medical University. Participants are randomly assigned to one of two groups: one receives embryo culture under a constant 5% oxygen concentration, and the other under a sequential protocol reducing from 5% to 2%. Both groups follow their respective blastocyst culture protocols during in vitro fertilization or intracytoplasmic sperm injection cycles. The study monitors outcomes related to live births and health status of offspring associated with each oxygen protocol. Women enrolled in the trial will be followed for three years, during which live birth rates, clinical pregnancy rates, implantation rates, miscarriage rates, and ectopic pregnancy rates will be recorded. Researchers will also assess offspring health by measuring peripheral blood telomere length. Evaluations include monitoring pregnancy outcomes and any perinatal complications. Data will be statistically analyzed to determine the effects of oxygen concentration protocols on reproductive success and offspring well-being.

Researchers are exploring a new non-invasive method to select embryos during assisted reproductive technology treatments such as IVF and ICSI. This study evaluates an integrated approach combining artificial intelligence-enhanced morphokinetic (MK) analysis using time-lapse imaging and Raman spectroscopy (RS) of the spent culture medium to improve embryo assessment. The goal is to increase the clinical pregnancy rate by accurately identifying embryos with chromosomal abnormalities without the need for invasive genetic testing. The study has two phases. Phase I is a retrospective study collecting data to train the AI model combining MK and RS methods. Phase II is a prospective randomized controlled trial where participants are assigned to one of two groups: embryos selected by the MK-RS integrated method or embryos selected by traditional morphological assessment by embryologists. Embryo images are captured every 10 minutes, and spent culture medium is analyzed by RS to detect metabolic markers. The MK-RS method aims to complete embryo assessment within 5-6 days after fertilization. Participants will undergo IVF/ICSI treatment with embryo culture using a time-lapse incubator. Researchers will collect images and culture medium samples to analyze embryo development and metabolic profiles. The main outcome measured is the clinical pregnancy rate at 6-8 weeks of gestation. Secondary outcomes include miscarriage rate, multiple pregnancy rate, ploidy status, and live birth rate. The study involves monitoring embryo development, collecting biological samples, and evaluating pregnancy outcomes through follow-up.

Researchers are investigating the outcomes after transferring a mosaic embryo, which contains both normal and abnormal chromosomal cells, in women undergoing in vitro fertilization (IVF) with preimplantation genetic testing (PGT). This prospective study aims to understand if transferring these embryos results in successful pregnancies and healthy live births, as some studies have suggested. The research focuses on implantation rates and live birth rates to determine if mosaic embryos should be routinely offered for transfer to patients experiencing infertility. Participants will undergo a single transfer of a mosaic embryo to the uterus after completing an IVF cycle with PGT at the Colorado Center for Reproductive Medicine. PGT involves testing a small number of cells from the embryo before transfer. Embryos identified as mosaic are usually not transferred as standard practice, but this study evaluates their potential for successful pregnancy. The study does not use a placebo or comparison group. Women in the study will be monitored through multiple follow-up periods after embryo transfer. Researchers will assess implantation rates 3 to 4 weeks after transfer and track live birth rates up to 9 to 12 months later. Additional outcomes include miscarriage rates, pregnancy complications, stillbirth rates, prenatal testing results, and neonatal outcomes up to 15 months after birth. Participants will have various clinical evaluations and tests as part of their routine care during the study period, which lasts up to about a year after embryo transfer.

Researchers are evaluating the Aurora test, a non-invasive method aimed at improving embryo selection during In Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) cycles. The study focuses on women undergoing ICSI treatment and compares embryo selection based on traditional morphology with selection that also includes the Aurora test score. The goal is to see if this new test can increase clinical pregnancy rates and live birth rates. The Aurora test analyzes mRNA expression in cumulus cells surrounding the oocyte to predict the embryo's developmental potential, offering an objective alternative to current subjective assessments. The study involves patients undergoing either fresh or frozen single embryo transfers on day 5 after fertilization. The Aurora test is conducted by analyzing cumulus cells collected during oocyte retrieval. RNA is extracted and evaluated to assign an Aurora test score to each embryo, indicating its pregnancy potential. Embryos are first selected based on morphology, then ranked by this score to determine transfer order. If no live birth occurs and the trial is ongoing, frozen embryo transfer cycles will also use the Aurora test for selection. The study includes a prospective group and two matched historical control groups for comparison. Participants will have their cumulus cells collected and analyzed, with embryo development tracked by embryologists based on morphology and Aurora test scores. Outcomes measured include blastocyst selection at day 5, clinical pregnancy rates confirmed by ultrasound, and live birth rates. Patient eligibility, embryo development, and transfer outcomes will be monitored throughout the study, with data compared against historical controls. The total participation duration depends on treatment cycles and pregnancy outcomes, with follow-up extending through frozen embryo transfers if applicable.

Researchers are investigating whether producing sperm after a very short abstinence period of just 1 hour can improve the rates of embryos with normal chromosomes during in vitro fertilization (IVF) treatment. The study aims to compare this ultrashort abstinence with the current standard abstinence period of 2 to 5 days to see if it leads to better embryo quality and pregnancy outcomes. This research is focused on couples experiencing infertility, particularly male factor infertility, and is sponsored by UConn Health. Participants will provide two sperm samples on the day of egg retrieval: one after the standard 2-5 days of abstinence and another after only 1 hour of abstinence. Their eggs will be randomly divided into two groups, with half fertilized using sperm from the standard abstinence sample and the other half fertilized using sperm from the ultrashort abstinence sample. Both groups will be part of the IVF process involving insemination or injection of sperm into the eggs. The study will assess embryo chromosome normality and other IVF outcomes. During the study, participants will undergo egg retrieval and fertilization procedures, with close monitoring of embryo development. Researchers will evaluate the rate of chromosomally normal embryos within 2 to 4 weeks of the IVF cycle, as well as pregnancy rates after embryo transfer, fertilization rates, and blastulation rates. Participation lasts through these IVF cycle stages, with data collected to understand how sperm abstinence timing affects embryo quality and pregnancy chances.

Researchers are evaluating the safety and effectiveness of a fixed combination of recombinant follitropin alfa and lutropin alfa compared to human menopausal gonadotropin (hMG) in Japanese women with luteinizing hormone (LH) and follicle stimulating hormone (FSH) deficiency undergoing assisted reproductive technology (ART). This Phase 3 study focuses on follicular development and aims to understand how these treatments perform in this patient group. The study duration is about 5.5 months for participants who do not become pregnant and up to 13 months for those with confirmed pregnancy in Part A. Participants will be randomly assigned to receive either the fixed combination of follitropin alfa and lutropin alfa in a 2:1 ratio or hMG. Both treatments are administered subcutaneously once daily for up to 18 days during ovarian stimulation. Additional medications include daily injections of cetrorelix acetate from Day 5 or 6 until the day of recombinant human chorionic gonadotropin (r-hCG), followed by a subcutaneous injection of corio gonadotropin alfa during final follicular maturation. After oocyte retrieval, participants will self-administer progesterone gel intravaginally daily to support the luteal phase. Throughout the study, participants will undergo various assessments including follicle counts via ultrasound, serum estradiol measurements, and embryo evaluations such as fertilization rates and blastocyst freezing. Safety monitoring will track adverse events, including ovarian hyperstimulation syndrome (OHSS), laboratory changes, and local reactions. The primary outcome is the total number of oocytes retrieved approximately 36 to 38 hours after r-hCG administration. Secondary outcomes include gonadotropin dosage, treatment duration, pregnancy rates, and safety events. Regular visits and monitoring will support adherence and collect data over the study period.