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Infertility clinical trials

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NCT ID: NCT03438682 Not yet recruiting - Contraception Clinical Trials

Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization

Start date: May 31, 2018
Phase: N/A
Study type: Observational

More than 345,000 U.S. women undergo either tubal ligation ("getting her tubes tied") or Essure procedures each year to permanently avoid pregnancy. Both prevent pregnancy by blocking women's Fallopian tubes but neither are 100% effective. Both can have complications, but not enough is known to help women make an informed choice between the two. Essure is popular because it can be performed without anesthesia in a doctor's office and women can return to work the next day. However, patients have reported that the Essure procedure was unexpectedly painful. Also, women need to use other contraceptives for 3 months and then return for testing, to make sure their tubes are blocked and will prevent pregnancy. Not all women return for this test and some may get pregnant before realizing their Essure didn't work. Essure was approved by the Food and Drug Administration (FDA) in 2002, but no studies ever compared it to tubal ligation. By 2015, over 9,000 women reported serious complications to the FDA. Women who were unhappy with Essure found each other online and created a Facebook "Essure Problems" support group that now has over 31,000 members. After an FDA Advisory Board expressed concerns about Essure's risks, in 2016 the FDA required stronger warnings about complications and announced that "more rigorous research" was needed, demanding Essure's maker conduct a new study comparing the benefits and risks of Essure to tubal ligation. Unfortunately, that study will not be finished before September 2023. To provide answers as rapidly as possible for women considering sterilization, we will analyze data from the medical records of thousands of women with sterilization procedures funded by California's Medicaid. As poor women and women of color have different experiences with healthcare, and they more often choose sterilization, comparing these women's experiences with Essure and tubal ligation is very important. We will compare the safety and effectiveness of the 2 sterilization procedures to answer: - How many women got pregnant afterwards? - How many operations did each woman need to become infertile? - Which complications did women have (i.e. chronic pain, depression)? We will also check whether certain women (such as certain age groups or those with diabetes) were most likely to have problems after either procedure.

NCT ID: NCT03436758 Recruiting - Infertility Clinical Trials

Validation of Addition of Uterine Fluid to Human Embryo Culture Medium

Start date: January 30, 2018
Phase: N/A
Study type: Observational

Infertility or infertility affects about 15% of couples of reproductive age. It is estimated that 80 million people around the world suffer from this problem. Assisted reproduction techniques (ART) use culture media (during in vitro fertilization or early embryo development) with protein sources that are very different from natural sources. This media could produce an added stress to the gametes and embryos that could cause epigenetic alterations and health effects during adult life. Our working hypothesis is based on studies in animal models (pig and cow), in which it was observed that the culture media with reproductive fluids used as additives instead of conventional sources of proteins (such as serum albumin) , produce embryos with an epigenetic profile closer to that of embryos generated in the maternal oviduct. Moreover, with these fluids, blastocysts obtained have a greater number of cells and hatchability than those produced with serum albumin alone. Therefore, the University of Murcia, with an extensive experience in this area, and the IVI Murcia (Valencian Infertility Institute) research team have come together to launch this research project in order to determine the advantages of the use of human reproductive fluids as additives in embryonic culture media. To do this, 2 specific objectives are proposed,: 1. Creation of the first collection of human uterine fluid samples for Assisted Reproduction use. 2. To evaluate the use of uterine fluid as a media supplement in the culture media for assisted reproduction techniques, by evaluating embryo quality cultured with autologous fluid from voluntary patients (autologous culture) This achievement would allow us the development of protocols in the nearest ART physiological conditions which represent not only a technical challenge but a biomedical responsibility that must be addressed to prevent future diseases of the offspring.

NCT ID: NCT03435809 Not yet recruiting - Infertility Clinical Trials

Pozzi Forceps in Intrauterine Insemination

Start date: February 2018
Phase: N/A
Study type: Interventional

Many infertility and subfertility issues are treated nowadays with intrauterine inseminations. This is a minimally invasive technique that consists in placing sperm into a woman's uterus. Inseminations have only a fair success rate despite advances in technology ( 7 % per cycle). The goal of this study is to find an easy intervention that could help with success rate. Some studies are showing that the use of Pozzi tenaculum forceps might increase rates of pregnancy following intrauterine inseminations. In order to study the impact of this intervention, we are conducting a randomized controlled trial comparing the rate of term live births after IUI between patients who had their treatment done with a pozzi tenaculum forceps and those who had their treatment done without a tenaculum forceps.

NCT ID: NCT03429621 Not yet recruiting - Clinical trials for Sterility, Postpartum

Effect of Simethicone on Reducing Bowel Interference During Tubal Resection

Start date: February 2018
Phase: Phase 3
Study type: Interventional

Tubal ligation is an everyday procedure for permanent female sterilization. It is usually performed after a vaginal delivery. Minilaparotomy is generally performed by doing small incision at infraumbilical area. This minimal access surgery requires adequate operative field exposure. Bowel interference, which obscures visualization of the operative field has been recognized as one of the major obstacles during this procedure. We found problems while doing surgery in small space and one of them is bowel interferance which obscures vision. This could lead to prolonged operation and complications. Simethicone is an antifoaming agent that use in bowel preparation prior to various procedures including laparoscopy, colonoscopy, endoscopy, and open major abdominal operations. Simethicone is proven to break the bubble and reduce intraluminal gas. This effect could result in reduction of bowel dilatation that interfere with the proper identification of the adnexal area. Benefit of taking simethicone prior to do minilaparotomy for tubal resection has not been examined. Objectives: To examine the effect of simethicone on reducing bowel interference during minilaparotomy for tubal resection. Design: A randomized controlled trial in women, age 20-45 years, undergoing postpartum sterilization after vaginal delivery at Faculty of Medicine, Chiang Mai University hospital. The participants will be randomly assigned into one of two study groups: intervention (taking simethicone) and control (not taking simethicone). For the intervention group, each woman will take simethicone (80 mg) 2 tablet chewing with water 50 ml at 2-8 hours before surgery. Fasting at least 6 hours before surgery. For the control group, the women will receive the same standard perioperative care without taking simethicone. The primary outcome measure will be surgeon-rated operative difficulty score, which is a visual analog scale based on assess from exposure of to the operative field in visual analog scale by surgeon. The secondary outcome will be operative time and incidence of intraoperative and postoperative complications.

NCT ID: NCT03429478 Recruiting - Clinical trials for Inflammatory Response

Effect of Preoperative Music on Sterile Inflammation Induced by Laparoscopic Surgery

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

Surgery induced sterile inflammation leaves behind a biomolecular footprint measurable by various pro-inflammatory markers e.g. IL-6, CD(Cluster of differentiation)19B, HsCRP(High-sensitivity CRP) etc. Music is a non-pharmacological means in attenuating this inflammatory pathway thereby improving Health related quality of life measurable by improved postoperative convalescence. Correct timing of music application is a lacuna in the knowledge. This research aims at evaluating the effect of preoperative music on sterile inflammation induced by index Laparoscopic Surgery (Laparoscopic Cholecystectomy) and its proposed beneficial effects on patient reported outcomes. A total of 50 patients divided into 2 groups (test and control) will be evaluated in this triple blind randomized controlled study aiming at evaluating the biomolecular signatures of sterile inflammatory response and its correlation with improved postoperative convalescence. All the patients will be followed up for a period of 1 month postoperatively to assess for overall improvement in health related quality of life. Collected data will be analysed using updated SPSS software and a p value of less than 0.05 will be taken as statistically significant in support of the measured indices.

NCT ID: NCT03428919 Not yet recruiting - Infertility Clinical Trials

ICSI Versus Conventional IVF in Non-male Factor Couples

Start date: March 2, 2018
Phase: N/A
Study type: Interventional

Conventionally, ICSI was initially developed and has been shown to be an effective treatment for male factor infertility. It is increasingly being used for patients without a male factor diagnosis, despite the lack of clinical evidence to support its use. Moreover, ICSI is an invasive and expensive procedure. This multi-center, randomized, controlled, parallel-group trial will be conducted to compare the effectiveness of ICSI versus conventional IVF in infertile couples scheduled for IVF treatment, in whom the male partner has normal sperm.

NCT ID: NCT03426007 Recruiting - Infertility, Female Clinical Trials

Controlled Ovarian Stimulation and Human Uterine Lavage

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

This is a feasibility study intended to demonstrate the Previvo Uterine Lavage System's ability to recover embryos from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).

NCT ID: NCT03421041 Not yet recruiting - Infertility, Female Clinical Trials

Study of Value of Dexamethasone Used in Ovulation Induction

Start date: April 1, 2018
Phase: N/A
Study type: Interventional

This study intends to solve the following problems: whether use dexamethasone can obviously decrease transplant cancelling probability in fresh embryo transplant cycle or not, reduce time and frequency going to hospital repeatedly for patients need frozen embryo transplant or not, and reduce the economic burden for patients or not; By comparing pregnancy rate of single transplant, hope to make clear in IVF-ET treatment for patients progesterone increases to a certain level whether it is a good choice to transfer fresh embryo after dexamethasone treatment, or frozen embryo transplant is better.

NCT ID: NCT03420859 Recruiting - Infertility Clinical Trials

The Microbiome of Infertile Couples and Its Effect on Their Reproductive Outcomes

Start date: December 4, 2017
Phase: N/A
Study type: Observational

A prospective cohort study in IVF patients at 5 IVF centres in Denmark. The primary aim is to include patients positive for abnormal vaginal microbiota to an RCT. Secondary aims are the prevalence of abnormal vaginal microbiota in women undergoing IVF treatment, intimate hygiene and relations to the vaginal microbiota, basic fertility work up in relation to vaginal microbiota.

NCT ID: NCT03414567 Not yet recruiting - Female Infertility Clinical Trials

Presence of Toxins From Smoking in the Follicular Fluid of Women Undergoing Intracytoplasmic Sperm Injection Treatment

Start date: March 1, 2018
Phase: N/A
Study type: Observational

Smoking is associated with many adverse health effects like circulatory disorders, pulmonary diseases or heart diseases. It was also shown that smoking correlates with a significantly higher risk for miscarriage, preterm birth or a significantly decreased implantation rate or life birth rate, thus affects the chance to have children. Combustion of tobacco products results in more than 4.000 toxic and/or carcinogenic substances. Examples of such substances are the carcinogenic substance Benzo(a)pyrene or nicotine and its main degradation product cotinine. Although the adverse effects of these substances were analyzed in many biological systems (e.g. cell culture, mouse model systems), less is known about the bio-accumulation in human tissue, especially in ovarian tissue or the follicular fluid (FF). The aim of this study is therefore to analyze the bio-accumulation of nicotine, cotinine and Benzo(a)pyrene in the follicular fluid of women with the unfulfilled desire to have children undergoing an intracytoplasmic sperm injection (ICSI) treatment. The analysis will be performed using a sensitive gas chromatography-mass spectroscopy (GC) in a control group (non-smoker) and a study group (smoker). For each group, a correlation analysis between the amount of toxic and/or carcinogenic substances and the clinical outcome (e.g. clinical pregnancy rate, fertilization rate) will be performed. In combination with a patient questionnaire, it will be possible to analyze the risk of smoking, the bio-accumulation of toxic substances in the follicular fluid, and the chance to have children.