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NCT05179993
Plastic products have been used ubiquitously in the modern world for many decades - for example as packaging materials, textile fibers or molded parts. The general use and especially the improper disposal lead to enormous environmental pollution almost everywhere on earth. Microplastics mainly originate from fragmentation of larger plastic objects or can be produced directly for the use in e.g. cosmetics or industrial dyes. Microplastics have already been detected in fresh- and seawater, soil, food, but also in human blood and urine. The accumulation of microplastics in ovarian and testicular tissue in humans has not yet been investigated.
NCT06826365
Specialized immunological studies in the diagnostics of idiopathic infertility and recurrent miscarriages have limited applicability, as the role of the immune system in these conditions is not thoroughly understood. In ovulatory cycles, changes occur in the populations of uterine lymphocytes, which may influence the receptivity of the endometrium and the implantation of the embryo. Particularly notable are the changes in natural killer (NK) cells, which reach their peak during the luteal phase and regulate the invasion of the trophoblast. The dominant NK cells exhibit a CD56bright phenotype and differ in cytokine profiles from peripheral blood cells. Cyclical changes also affect macrophages and T lymphocytes; however, it is unclear whether their proportions differ in women with reduced fertility. There is a need to investigate how the composition of lymphocytes in blood influences the populations in the endometrium. The aim of this study is to analyze the correlation between peripheral and endometrial lymphocytes in women with idiopathic infertility and recurrent miscarriages, compared to fertile women.
NCT01511588
Background: \- The body produces gonadotropin-releasing hormone (GnRH) about every 2 hours. GnRH travels through the bloodstream to the pituitary gland, where it stimulates the gland to produce hormones called gonadotropins. These hormones stimulate the testicles or ovaries. The testicles produce testosterone and develop sperm. The ovaries produce estrogen and prepare for ovulation. Normal estrogen and testosterone levels are required for puberty. Some people, however, have either low levels or total lack of GnRH. This can cause problems with puberty and fertility. Researchers want to study people with low or no GnRH to better understand how it affects puberty and fertility. Objectives: \- To study disorders of GnRH production. Eligibility: * Adult men and women at least 18 years of age with low or no gonadotropin levels. * Adolescents between 14 and 18 years of age with low or no gonadotropin levels. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * Participants will have tests to look at their hormone levels. Blood samples may be collected after taking different drugs, including insulin and cortisone. A 24-hour urine sample will be collected. * Participants will have imaging studies to look at bone and brain development. They will also have ultrasounds of the kidneys, abdomen, and reproductive organs. * Tests of smell and hearing will be used to look for abnormalities in these senses.
NCT07153367
The aim of this study is to evaluate the use of a fixed dose of 3.66 mcg of follitropin delta (Rekovelle) on ovarian response during ovarian stimulation for intrauterine insemination (IUI). The assumption is that this fixed dose will be effective while minimizing the risk of multiple pregnancies. A recent study demonstrated the efficacy of follitropin delta for ovarian stimulation in IUI, and it has been approved in France for controlled ovarian stimulation in assisted reproductive techniques such as in vitro fertilization (IVF) and IVF with intracytoplasmic sperm injection (ICSI). With an adapted dose of Rekovelle for patients with regular menstrual cycles, ovarian stimulation is optimized from the first attempt, promoting the development of two follicles to improve pregnancy chances while reducing the risk of multiple pregnancies. This approach aims to achieve pregnancy faster and provide a more comfortable treatment experience.
NCT04610710
The EFFORT study compares the impact on fertility of operation or fertility treatment (IVF, in vitro fertilization) in a multicenter randomized controlled trial. The study population consists of women with colorectal deep infiltrating endometriosis and a pregnancy intention. These women will be randomized to either of the two treatment groups: Group A = Operation or Group B = fertility treatment (IVF). Group A will be further divided postoperatively into spontaneous conception or IVF depending on the Endometriosis Fertility Index score.
NCT07449260
TSH has been suggested to be involved in reproductive challenges such as ovulatory issues, infertility, miscarriage, and maternal complications for many years. Multiple studies have associated thyroid function with ovarian function and reproductive physiology. The thyroid hormone can impact follicle development, as well as the metabolism of estrogen and androgen, the menstrual cycle, and the receptivity of the endometrium
NCT04872660
The purpose of this study is to investigate whether oral Gushen Antai pills supplementation for luteal phase support will improve ongoing pregnancy rate in women with normal ovarian reserve in fresh embryo transfer cycles.
NCT07461077
Background: Morphology-based embryo selection cannot detect aneuploidy, which is common in advanced maternal age and recurrent pregnancy loss. NICS-AI combines non-invasive chromosome screening (NICS) of cell-free DNA from spent blastocyst culture medium with AI integration of developmental day and morphology to improve embryo ranking. Methods: This multicenter, single-blind, parallel randomized controlled trial will include 520 participants. Participants undergoing conventional IVF will be eligible if they meet either (i) female age 35-43 years or (ii) recurrent miscarriage (≥2 losses \<28 gestational weeks, including biochemical pregnancy with serum hCG \>25 IU/L). They must consent to blastocyst culture/vitrification and frozen-thawed single blastocyst transfer (SBT), and have ≥2 Day-5/Day-6, 2PN-derived blastocysts with morphology grade ≥4BC/4CB at randomization. Key exclusions include any ICSI-based fertilization or PGT-related procedures, known genetic disease meeting PGT indications, donor oocytes, untreated uterine anomalies/hydrosalpinx, or contraindications to pregnancy/ART. Randomization/interventions: Participants will be randomized 1:1 to NICS-AI-guided selection or morphology-based selection. In the NICS-AI arm, culture-medium DNA is tested and an AI-derived composite implantation score ranks embryos; controls use morphology alone (tie-break by cryopreservation order). Outcomes/analysis: The primary endpoint is live birth after the first SBT (delivery with ≥1 live-born infant per transfer cycle, per randomized participant). Secondary endpoints include first clinical pregnancy, early miscarriage (\<12 weeks, excluding biochemical pregnancy), ongoing pregnancy to 12 weeks, and cumulative pregnancy/live birth outcomes within 1 year (≤3 SBTs from one retrieval). Safety includes fetal malformations and neonatal outcomes through 1 year postpartum.
NCT07462065
Women who meet the study requirements will be enrolled and randomly assigned by a computer system to receive either pioglitazone 30 mg daily or a placebo starting from the second day of their menstrual period for the same duration. All participants will also take clomiphene citrate 150 mg daily from day 3 to day 7 of the menstrual cycle. A transvaginal ultrasound will be performed on day 10 of the menstrual cycle to assess the growth of ovarian follicles, and the number of mature follicles (16-24 mm) will be recorded. If at least one mature follicle measuring 16-24 mm is present and the endometrial thickness is at least 7 mm, an injection of human chorionic gonadotropin (hCG) will be given to trigger ovulation, followed by an intrauterine insemination (IUI) procedure. Participants will be followed until the end of the menstrual cycle, and if the menstrual period is delayed by 5 days, a blood test for β-hCG will be performed to confirm pregnancy. Any side effects during the treatment period, such as swelling, fluid retention, blurred vision, or weight gain, will be recorded.
NCT07449494
This retrospective single-center observational cohort study evaluates live birth rates after the first embryo transfer following immune assessment in infertile women with documented uterine immune overactivation. In routine clinical practice, glucocorticoids represent first-line therapy for immune overactivation. Some patients underwent glucocorticoid sensitivity testing prior to embryo transfer based solely on standard clinical practice and patient preference. In cases of demonstrated glucocorticoid resistance, alternative therapeutic strategies were implemented according to usual care. The study analyzes clinical data collected between September 2020 and November 2025 to assess the association between prior glucocorticoid sensitivity testing and live birth rate after the first fresh or frozen blastocyst transfer performed following immune evaluation. No treatment allocation was determined by a study protocol.
NCT05903859
This is a study of infertility which often occurs in men with spinal cord injury. Most men with spinal cord injury have a normal sperm count but abnormally low sperm motility - which means that the sperm does not swim well. This study will determine if a medicine given by mouth will improve sperm motility in men with spinal cord injuries. The medicine is called probenecid.
NCT06742437
Prospective, multicenter research study with a split-sample design on semen samples, without intervention, to evaluate the efficacy and safety of HyperSperm, a new sperm capacitation method, in 300 semen samples with various characteristics and abnormalities, in an in vitro study over 12 months.
NCT07404969
The goal of this clinical trial is to determine whether telomere profiling and other biological aging hallmarks can help identify underlying mechanisms of persistent infertility in women with post-treatment unexplained infertility. The study also evaluates whether a personalized integrative treatment guided by these biomarkers can improve reproductive outcomes. The study includes women aged 25 to 42 years who continue to experience infertility despite appropriate management of identifiable reproductive conditions and repeated attempts with assisted reproductive technologies (ART), such as intrauterine insemination (IUI) or in vitro fertilization (IVF). The main questions this study aims to answer are: * Can telomere and biological aging hallmarks profiling identify a biological aging phenotype associated with infertility? * Can an integrative treatment guided by these profiles improve clinical pregnancy outcomes? Participants will: * Undergo a baseline reproductive evaluation and blood-based assessment of telomeres and aging hallmarks. * Receive an integrative approach combining Traditional Chinese Medicine (TCM), targeted nutritional support, and standard fertility care. * Proceed with natural conception attempts or standard assisted reproductive technologies following the preconception phase. * Participants will be followed to assess pregnancy outcomes and changes in biological aging hallmarks.
NCT07399535
Polycystic Ovarian Syndrome (PCO) is a metabolic disorder that afflicts the women of childbearing age. An approximate of 5-10% women are the victim of this disorder. PCOS is a leading cause of infertility in females these days and is characterized by Hyperandrogenism, Chronic Anovulation, Impaired fertility, obesity, Hirsutism, Acne, Obesity, Metabolic disturbances (dyslipidemias, Hyperinsulinemia, insulin resistance, and type- 2 diabetes), and Endometrial Hyperplasia. This study will test a combination of herbal medications (Melats P) in women with PCOS to determine which works best to overcome infertility.
NCT07386431
The goal of this study is to identify the molecular or genetic mechanisms that may predispose patients with bowel endometriosis to an increased risk of colorectal carcinoma. The study will include patients for whom surgical treatment of bowel endometriosis is clinically indicated. This research would represent a significant advancement in evaluating the necessity of surgical intervention in asymptomatic patients or those with mild symptoms. Furthermore, it would provide a broader insight into the systemic impact of endometriosis on other organ systems, ultimately improving risk assessment and preventive measures.
NCT07288866
Vitrification has become the gold standard for oocyte and embryo cryopreservation. Several commercial kits are available on the market, some are designed for specific developmental stages (e.g. oocytes, zygotes, cleavage-stage embryos or blastocysts) and others are suitable for several stages, therefore termed "universal". Oocytes, cleavage-stage embryos and blastocysts display different levels of resistance to cryopreservation, due to stage-specific properties. While the composition and the exposition protocol of stage specific media are optimized for specific developmental stages, "universal" media display a single composition, therefore exposition protocols should be adapted to each specific developmental stage to ensure optimal survival rates. The main objective of this study is to determine whether the shift from "oocyte specific" vitrification and warming media to "universal" media has an impact oocyte survival, embryological and clinical outcomes.
NCT07369362
The goal of this prospective, multicenter randomized controlled clinical trial is to evaluate whether the SwimCount Harvester microfluidic sperm preparation device can achieve equivalent or superior clinical outcomes compared to standard sperm preparation methods (density gradient centrifugation and swim-up) in couples undergoing in vitro fertilization (IVF) with preimplantation genetic testing for aneuploidy (PGT-A). The study population includes adult couples (female partner age 21-45 years; male partner age ≥21 years) undergoing IVF with PGT-A who meet minimum semen eligibility criteria on the day of oocyte retrieval: pre-processing volume ≥1mL, sperm concentration ≥1 million/mL, and progressive motility ≥10%. A total of 1,600 patients will be randomized 1:1 across 15-25 high-volume IVF centers to receive either Harvester or the site's predominant standard-of-care sperm preparation method. Patients with surgical sperm retrieval requirements or those currently using SwimCount Harvester as standard of care are excluded. The main questions it aims to answer are: Does the SwimCount Harvester demonstrate noninferiority to standard sperm preparation methods on blastocyst utilization rate? The primary endpoint is blastocyst utilization rate, calculated as the number of usable blastocysts (operationalized as biopsied blastocysts per clinic standard operating procedures) divided by the number of normally fertilized oocytes (2PN) at the patient level. Noninferiority will be concluded if the lower bound of the two-sided 95% confidence interval for the risk difference (Harvester minus standard of care) is greater than -2.0 percentage points, using a site-stratified Mantel-Haenszel analysis. If noninferiority is met, superiority may be reported as supportive evidence when the lower confidence bound exceeds zero. Does the SwimCount Harvester demonstrate noninferiority to standard sperm preparation methods on the probability of obtaining at least one euploid embryo per retrieval? The key secondary endpoint assesses whether patients have at least one euploid embryo (yes/no) based on PGT-A results from a single blinded reference laboratory (NOVA Genomics). This will be analyzed as a site-stratified Mantel-Haenszel risk difference with a two-sided 95% confidence interval, with an optional noninferiority margin of -2.5 percentage points presented as supportive evidence. Additional supportive and exploratory questions include: * How does progressive motility change from pre- to post-preparation with each method? Progressive motility will be summarized descriptively pre- and post-preparation as a supportive laboratory measure without hypothesis testing. * Do outcomes differ in clinically important subgroups? Pre-specified exploratory analyses will examine advanced maternal age (≥40 years) and severe oligospermia (\<5 million/mL), populations that may derive differential benefit from advanced sperm selection. * What are the practical implementation considerations? An independent protocol complexity analysis will assess procedural steps, equipment requirements, and standardization benefits by comparing site standard-of-care protocols to the Harvester Instructions for Use. The study addresses a critical evidence gap by providing multicenter, adequately powered data on whether advanced microfluidic sperm preparation translates into meaningful clinical improvements in IVF success metrics.
NCT07370857
This study was designed to investigate the effects of music medicine on anxiety, pain, and vital signs in women undergoing embryo transfer. The study followed a randomized controlled design and was conducted at the IVF unit of a university hospital. The sample consisted of women who met the specified inclusion criteria, and participants were assigned to the intervention and control groups using randomization. Data collection tools included a socio-demographic characteristics form, a vital signs recording form (blood pressure, pulse, respiratory rate, and oxygen saturation), the State-Trait Anxiety Inventory (STAI-I and II), and the Visual Analogue Scale (VAS). The intervention group listened to patient-selected music during the embryo transfer process, while the control group received standard care. Measurements were taken before, during, and after the embryo transfer. The obtained data were analyzed using appropriate statistical methods to evaluate the effects of music on anxiety, pain levels, and vital signs. This study aims to improve women's embryo transfer experiences by contributing to nursing care and reproductive health practices.
NCT07364409
For pre-pubertal boys undergoing gonadotoxic therapies, freezing immature testicular tissue (ITT) containing spermatogonial stem cells (SSCs) is currently the only option to potentially preserve future fertility. This experimental clinical study aims to provide proof-of-concept that frozen-thawed, ectopically autotransplanted adult human testicular tissue can support spermatogenesis in healthy adult men.
NCT07154888
The Fast Track to Fertility (FTF) program is an algorithmic text messaging communication and patient education platform designed to improve the efficiency the fertility workup. The initial pilot program resulted in an approximately 50% reduction in the time taken to complete the diagnostic workup. Since the pilot program, the investigators have enhanced the FTF Program (v2.0) beyond the texting platform, incorporating educational videos to increase patient knowledge and autonomy in the workup and treatment of infertility. This protocol pertains to a randomized controlled quality improvement initiative to measure the impact of the FTF v2.0 Program on fertility workup completion, efficiency, and patient outcomes.