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Infertility clinical trials

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NCT ID: NCT05548101 Not yet recruiting - Infertility Clinical Trials

Prospective, Randomized Trial Comparing ICSI to Insemination for Non-Male Factor Patients Undergoing PGT-A

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

Intracytoplasmic sperm injection (ICSI) is a procedure performed during in vitro fertilization (IVF) in which a single sperm is injected directly into an oocyte. This procedure was developed for male factor infertility due to its requirement for a very small number of viable sperm. However, its use has expanded and is now recommended for IVF cycles in which preimplantation genetic testing for aneuploidies (PGT-A) is performed on blastocysts. We hypothesize that the ICSI procedure may interfere with the normal meiosis II process that occurs during fertilization, and lead to a higher rate of aneuploid blastocysts. In our study we will randomly assign non-male factor infertility patients to either conventional insemination or ICSI and compare the rate of karyotypically normal embryos in each group.

NCT ID: NCT05514223 Not yet recruiting - Infertility Clinical Trials

Measuring Free Radicals in Human Sperm Cells Related to Microbiota and Lifestyle Factors

SIRIUS
Start date: March 1, 2024
Phase:
Study type: Observational

The cause of infertility can be due to a female factor or a male factor. In case of a male factor, it is often due to poor semen quality. However, the cause of poor quality is often unknown. In previous research, infertility problems in men were related to chemical processes in metabolism causing the formation of free radicals. Free radicals are physiological by-products of our body mechanisms. Free radicals are very reactive and can therefore react with a lot of molecules of cells within our body and cause damage. A balance between free radicals, which are also needed for physiological processes in the body, and antioxidants, which defuses the reactive free radicals, is most desirable. However, as stated in literature, there are a lot of factors that can influence extra free radical production, which causes overloading of the system, resulting in damage on cellular level. Free radicals in semen plasma and on the sperm cell could play a role in male infertility. Nonetheless, free radicals are not used as diagnostic markers due to the lack of detection systems, as free radicals are very short-lived. This study aims to introduce a new technique, called diamond magnetometry, to measure free radicals directly on the sperm cell and in serum. Diamond magnetometry involves very small diamond particles as magnetic sensors that engage a reaction with the free radicals on the sperm cell, causing signals that can be measured. To compare local free radical production with systemic free radical production, other diagnostic biomarkers are also measured in serum. It is hypothesized that the composition of seminal microbiome could influence the free radical concentration. Therefore, this study also aims to explore the microbiota composition and see if this has an influence in semen quality and free radical production. At last, this study also want to correlate standard semen parameters (defined by the World Health Organisation), lifestyle factors and food intake, to detect a role for lifestyle in the production of free radicals.

NCT ID: NCT05480540 Not yet recruiting - Education Clinical Trials

The Effect of Serious Games

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Today, there is a need to integrate and restructure rapidly developing technology into teaching environments. When web-based applications, which are among the popular and innovative technologies, are examined, it is seen that they are used in many areas of education. In this study, it was aimed to evaluate the effects of sterile hand washing, sterile dressing, sterile package opening and surgical instrument preparation training on anxiety, satisfaction, knowledge and skill levels by designing a serious game-based web application that allows nursing students to gain skills and practice in psychomotor applications. The universe of the study will consist of students enrolled in the Operating Room Nursing course in the Nursing Department of the Faculty of Health Sciences of Gümüşhane University in the spring semester of the 2021-2022 academic year, and the sample will consist of 94 students who meet the study criteria and agree to participate in the study. Data; It will be collected with the Introductory Characteristics Form, Operating Room Applications Information Form, Sterile Dressing and Surgical Instrument Preparation Skills Checklist, State Trait Anxiety Scale (WHO) and Visual Comparison Scale (GLO). Oral lectures will be given to all students by the instructor in charge of the course for two hours a week for two weeks, according to the lesson plan. Before the oral presentation, the 'Student Information Form' and the 'Operating Room Applications Information Form' will be applied to the students. After the questionnaire applications, the students will be divided into two groups, 47 students in the intervention group and 47 students in the control group, by randomization method. A serious game-based web application will be downloaded to the mobile phones of the students in the intervention group, on sterile dressing and surgical instrument preparation training, prepared in accordance with the formal education curriculum. How to use it will be shown. The students in the control group will be shown the video prepared by the researcher on sterile dressing and surgical instrument preparation training. Students in both groups will be informed that they can use this application for two weeks whenever they want and as much as they want. At the end of two weeks, a skill test will be given to the control and intervention groups in the laboratory. WHO will be applied to both groups before and after the skill test. Immediately after the skill test, the Operating Room Applications Information Form will be applied to both groups to measure the level of knowledge, the State Anxiety Inventory (DBS) to determine their anxiety level, and the GAS to measure satisfaction. Three weeks after the first skill test, students' second skill measures will be evaluated using the 'Surgical Instrument Preparation Skill Checklist', and their anxiety levels will be evaluated with the Trait Anxiety Inventory. The obtained data will be analyzed with appropriate statistical methods using the SPSS for Windows 23.0 program (Statistical Package for the Social Sciences)

NCT ID: NCT05412147 Not yet recruiting - Infertility, Female Clinical Trials

The Effect of RECO-18 on Infertile Women Undergoing in Vitro Fertilization-embryo Transfer

Start date: July 2022
Phase: N/A
Study type: Interventional

How to improve the fertility of infertile women has become a hot topic in the field of assisted reproduction. Animal experiment has shown that RECO-18 significantly improved the female fertility in mice, and the specific mechanism was related to reducing follicular atresia, promoting follicle development and improving oocyte quality. Therefore the investigators aim to conduct a pilot study to explore the effect of RECO-18 in infertile women undergoing assisted reproduction treatment. This study is a prospective, randomized, controlled clinical study. The treatment group takes RECO-18 while the control group takes the multi-vitamins. The primary indicator is the ongoing pregnancy rate at 12 weeks' gestation; the secondary indicators are the number of oocytes retrieved, the normal fertilization rate and the rate of high quality embryos, implantation rate, clinical pregnancy rate, and early miscarriage rate.

NCT ID: NCT05397795 Not yet recruiting - Infertility Clinical Trials

COMPARING TWO PROTOCOLS FOR FINAL OOCYTE MATURATION IN POOR RESPONDERS UNDERGOING GnRH-ANTAGONIST ICSI CYCLES

Start date: June 1, 2022
Phase: Phase 3
Study type: Interventional

Poor ovarian responders (POR) include a significant proportion of women referred for IVF treatments (ranging from 9 to 24 %), most of whom are in late reproductive age. In fact the live birth rate in the entire POR category is poor (about 6 % per cycle). However patients <40 years have a significantly better prognosis compared to older patients, mainly due to better oocyte quality.Attempts to improve IVF cycle outcomes for poor responders included modifying the steps of ovarian stimulation protocols , such as different luteal phase pretreatments, increasing ovarian stimulation doses, as well as addition of various supplements. So far, most of the modifications had limited success, therefore, optimal protocol for poor responders has remained elusive. Final oocyte maturation trigger is one of the most important key success factors in assisted reproductive technologies (ARTs). Oocyte maturation refers to a release of meiotic arrest that allows oocytes to advance from prophase I to metaphase II of meiosis. Luteinizing Hormone (LH) surge by dismantling the gap junctions between granulosa cells and oocyte inhibits the flow of maturation inhibitory factors into ooplasm and causes drop in concentration of cAMP. Decreased concentration of cyclic AMP (cAMP) in turn increases concentration of Ca and maturation-promoting factor (MPF), which are essential for the resumption of meiosis in oocyte and disruption of oocyte-cumulus complex triggering follicular rupture and ovulation about 36 h the LH surge. The aim of the study is to compare the oocyte yield , oocyte quality and the ongoing pregnancy rate between dual trigger treatment (combination of gonadotrophin-releasing hormone (GnRH) agonist and human chorionic gonadotrophin) and human chorionic gonadotrophin alone in PORs undergoing in vitro fertilization/intracytoplasmic sperm injection (IVF-ICSI) cycles using a GnRH-antagonist protocol.

NCT ID: NCT05385848 Not yet recruiting - IVF Clinical Trials

Autologous Platelet-rich Plasma (PRP) Infusion to Improve Outcomes in Women With Ovarian Insufficiency: a Pilot Study

Start date: May 2022
Phase: N/A
Study type: Interventional

The investigators propose a pilot study to determine if autologous platelet-rich plasma (PRP) improves ovarian reserves and In-vitro fertilisation (IVF) outcomes in women with diminished ovarian reserve / premature ovarian insufficiency.

NCT ID: NCT05362799 Not yet recruiting - Infertility, Female Clinical Trials

Different Induction Protocols in PCOS After Clomiphene Citrate Failed Pregnancy in Non-IVF Cycles

Start date: June 1, 2022
Phase: Phase 4
Study type: Interventional

The aim of this study will be to compare between 4 different induction protocols in women who: 1. Failed to achieve ovulation after clomiphene citrate treatment at a dose of 150mg daily (if the patient can tolerate this dose) for 5 days for 3 cycles or only 100 mg daily for the same duration (if she can't tolerate higher dose) 2. Failed to achieve pregnancy after 3 cycles of ultrasound indicated ovulation with clomiphene citrate treatment at a dose of 100mg or 150mg daily. All induction protocols will be carried out in non-IVF cycles, and continued for 3 cycles or until pregnancy whichever will be earlier.

NCT ID: NCT05351567 Not yet recruiting - Infertility, Female Clinical Trials

Transformatıonal Learnıng Theory on Infertılıty and Stigma in Infertılıty Women

Start date: May 15, 2022
Phase: N/A
Study type: Interventional

This study will be conducted to evaluate the effect of the education program created according to the transformational learning theory on women being affected by infertility and feeling stigmatized due to infertility. The research is a single center parallel group simple randomized controlled trial. The sample consisted of 52 participants in total. determined to be formed. Diagnosed with infertility, literate, 18 years of age and older, no communication disability, and Women who volunteer to participate will be included in the study. Personal Information Form, Infertility Affected Scale and Infertility Stigma (Stigma) Scale will be used to collect data. Groups of 3-10 people were formed for the women in the experimental group. A training program consisting of four modules will be implemented once a week. Data analysis in SPSS 22.0 package program will be.

NCT ID: NCT05337072 Not yet recruiting - Subfertility Clinical Trials

The FLORA-project: in Search for the Microbial Cause of Chronic Endometritis and the Most Appropriate Treatment to Obtain a Successful Pregnancy IVF/ICSI

FLORA
Start date: May 1, 2023
Phase:
Study type: Observational

Chronic endometritis is an inflammatory condition of the endometrium. This inflammation can negatively affect fertility and pregnancy. The pathology is frequently (+-10%) observed in women with fertility problems. Today, diagnosis of chronic endometritis is not evident, since no well-validated classification scales are available. In the UZ Brussel the pathology department applies its own in-house scoring system, based on the presence and position of plasma cells within the histological images. Despite limited research so far, it recently became clear that the endometrium is colonized by micro-organisms (the microbiome). However, it is still unclear what role these microorganisms play in chronic endometritis and fertility problems. Chronic endometritis is often diagnosed in the context of fertility problems, and the patient is treated 'blindly' with broad-spectrum antibiotics such as doxycycline. Broad-spectrum antibiotics unnecessarily eradicate many microorganisms in our body, including the ones that positively influence implantation. The exact cause of chronic endometritis is unknown, so treatment remains empirical. The research and knowledge in the endometrial microbiome is constantly expanding, mainly due to the rise of research into the links between pathologies and human microbiota. It is becoming increasingly clear that the composition of the microbiome can play a vital role in health and disease. Regarding the influence of the endometrial microbiome on different pathologies, such as chronic endometritis and implantation failure or miscarriage, there is still no consensus. Despite multiple studies on the endometrial microbiome, we are not yet able to define a normal or healthy endometrial microbiome. In this project, we want to gain insight into the microorganisms that are present in the female reproductive tract based on various techniques. The analyses will performed on an endometrial biopsy and a vaginal swab. The biopsy is routinely taken at Brussels IVF for the detection of plasma cells in the anatomopathology lab for the diagnosis of chronic endometritis. In the microbiology lab we will investigate which microorganisms are present in the female reproductive tract with and without the histological diagnosis of chronic endometritis. This will be done based on the state-of-the-art analytical techniques metagenomics (sequencing) and culturomics (culture).

NCT ID: NCT05298657 Not yet recruiting - Endometriosis Clinical Trials

The Angiotensin-Melatonin Axis in Poor and Hyper Responders for IVF Treatment

Start date: September 1, 2022
Phase:
Study type: Observational [Patient Registry]

According the World Health Organization (WHO), infertility is a disease of the male or female reproductive system defined by the failure to achieve a pregnancy after 12 months or more of regular unprotected sexual intercourse. In-vitro-fertilization (IVF) is considered to be a successful tool to overcome infertility. However, the current methods used to assess the ovarian reserve and to develop an optimal individualized controlled ovarian hyperstimulation (COH) protocol have shown some limitations. Growing evidence indicates that altered renal renin-angiotensin system (RAS) and/or melatonin are linked to infertility. Aims and Objectives: The current 2 years duration study aims first to investigate the demographic and clinical profiles of patients undergoing IVF in the UAE. In the second phase of the study, we hypothesis that an altered angiotensin-melatonin axis may be considered as an unfavorable prognosis factor in poor and hyper responders undergoing IVF treatment. This hypothesis will be assessed using an observational, longitudinal, prospective clinical study to determine whether the urinary angiotensinogen and/or melatonin deficiency might be present in poor and hyper responders undergoing IVF treatment. Thus, negatively impacting the clinical pregnancy rate. Methodology: various patient's data will be collected using a questionnaire and the levels of angiotensinogen and melatonin in patient's urine will be measured using ELISA test prior to, during and after the IVF treatment. To determine whether the angiotensinogen-melatonin axis disruption affects the IVF treatment outcome, we will analyze the following parameters: the AMH, Antral Follicular Count (AFC), day 2-4 FSH levels, the stimulation cycle in regards to number of stimulation days and amount of gonadotropins used for stimulation, number of oocytes retrieved and number of mature oocytes, quality and embryo's ploidy, number of available euploid embryos and the clinical pregnancy rate after frozen embryo transfer.