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Leiomyoma clinical trials

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NCT ID: NCT04191603 Not yet recruiting - Cervical Dysplasia Clinical Trials

TWO DİFFERENT ELECTROSURGERY DEVICES AS MONOPOLAR HOOC AND PLASMAKINETIC BIPOLAR SPATULA EFFECTIVENESS DURING COLPOTOMY

Start date: October 30, 2020
Phase: N/A
Study type: Interventional

WE DECIDED TO COMPARE TWO DIFFERENT ELECTROSURGERY DEVİCES TO PROVIDE COLPOTOMY. ONE OF THEM İS MONOPOLAR HOOC, THE OTHER DEVİCE İS PLASMAKİNETİC BİPOLAR SPATULA. WE WİLL RANDOMİSE PATİENTS FİRSTLY THEN COMPARE THE RESULTS SUCH, VAGİNAL DEHİSSENS, COLPOTOMY DURATİON, AMOUNT OF MIST DURING COLPOTOMY, AMOUNT OF BLEEDİNG.

NCT ID: NCT04030273 Not yet recruiting - Myoma;Uterus Clinical Trials

Prevalence of Intrauterine Adhesions After Abdominal Myomectomy

Start date: January 2022
Phase:
Study type: Observational

Uterine fibroids are the most common benign tumors of the genital organs of women of childbearing age. Literature data show that more than 75% of women have fibroids.Symptomatic fibroids account for approximately over 200,000 hysterectomies and 50,000 myomectomies annually in the United States. Fibroids have a major impact on fertility, with significant adverse effect on implantation rate and spontaneous abortion rates when compared with infertile women without fibroids. The definitive treatment for uterine fibroids in a fertile patient is surgical excision. Although usually effective, myomectomy is not a risk-free operation, since the surgical procedure can cause mechanical infertility and can be associated with infection, injury to adjacent tissues, hemorrhage and need to convert to hysterectomy. A not often mentioned consequence of myomectomy is post-operative intrauterine adhesion formation. It has been reported that 50% of women undergoing open myomectomy are found to have intrauterine adhesions diagnosed by hysteroscopy performed 3 months after surgery. Such a high prevalence of intrauterine adhesions after open myomectomy is unexpected, however only few studies have addressed this topic. It is accepted that injury to the endometrium is generally considered to be the primary causative factor for the development of intrauterine adhesions. The reason for such a high incidence of intrauterine adhesions after open myomectomy is unclear. It is speculated that infection or in adverted closure of the uterine cavity may play a role in intrauterine adhesion formation. The relationship between the number of fibroids removed and the risk of adhesions suggests a traumatic etiology. In the preservation of the uterus for the purpose of fertility, it is essential to also understand the impact of myomectomy on the endometrium. Currently no guideline recommends in office hysteroscopy as follow-up after myomectomy. The purpose of the present study is to evaluate the frequency of uterine adhesions following myomectomy and the impact of number, size and location of the fibroids as well as intraoperative breach of the endometrial cavity at the time of the myomectomy.

NCT ID: NCT03904368 Not yet recruiting - IVF Clinical Trials

The Value of Myomectomy in Women With Intramural Myoma Before IVF.

Start date: April 2019
Phase: N/A
Study type: Interventional

Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention . The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts. On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH), , estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.

NCT ID: NCT03586947 Not yet recruiting - Clinical trials for Vitamin D Deficiency

Association Between Vitamin D and the Risk of Uterine Fibroids

ABVDATROUF
Start date: September 15, 2018
Phase: N/A
Study type: Interventional

The aim of this randomised clinical trial study is to evaluate whether supplementation with vitamin D could reduce the risk of uterine fibroids in reproductive stage women.

NCT ID: NCT03584529 Not yet recruiting - Clinical trials for Vitamin D Deficiency

Association Between Vitamin D and the Development of Uterine Fibroids

Start date: September 15, 2018
Phase: N/A
Study type: Interventional

the aim of this randomised clinical trial study is to evaluate whether supplementation with vitamin D could inhibit the growth of uterine fibroids in reproductive stage women.

NCT ID: NCT03570879 Not yet recruiting - Myoma;Uterus Clinical Trials

Laparoscopic Myomectomy With Morcellation or Transvaginal Extraction of Surgical Specimens.

MYMOTE-1
Start date: May 1, 2022
Phase:
Study type: Observational

Laparoscopic myomectomy represents the fertility-sparing gold standard approach for the management of subserosal and intramural uterine myomas: this technique allows faster recovery, less complications and improved surgical outcomes than laparotomy. Despite these validated cornerstones of minimally invasive gynecology, the best approach for specimen retrieval is still debated. Among these approaches, surgical specimen retrieval after laparoscopic myomectomy could be performed by mini-laparotomy, by power morcellation using morcellator inserted through one of the ancillary trocars, or by transvaginal extraction through an endobag inserted at level of the posterior vaginal fornix (between the utero-sacral ligaments). Unfortunately, mini-laparotomy has poor esthetic outcome and does not conform the current standards of minimally invasive surgery. In addition, on 24 November 24 2014 the Food and Drug Administration updated a Safety Communication about Power Morcellation, warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids, due to the risk of spreading an unsuspected uterine sarcoma within the abdomen and pelvis. Considering this scenario, transvaginal extraction may represents a feasible approach for specimen retrieval. In this view, the current study aims to retrospectively compare surgical outcomes in women that underwent laparoscopic myomectomy with subsequent power morcellation (before the issuing of the abovementioned Safety Communication by the Food and Drug Administration) or transvaginal extraction (after the issuing of the abovementioned Safety Communication by the Food and Drug Administration) of the surgical specimens.

NCT ID: NCT03524950 Not yet recruiting - Hysteromyoma Clinical Trials

Effect of Dexmedetomidine on Stress Study of Pituitrin in Laparoscopic Hysteromyoma Surgery

Start date: June 1, 2018
Phase: Phase 3
Study type: Interventional

This study is about the effect of dexmedetomidine to the stress of pituitrin in laparoscopic hysteromyoma surgery. It is well known that pituitrin has been widespread used in the laparoscopic hysteromyoma surgery. Pituitrin includes oxytocin and vasopressin. Vasopressin increase body stress reaction through hypothalamic pituitary adrenal(HPA) axis. The HPA axis has has main role to the body stress reaction. Dexmedetomidine can inhibit the stress responses mediated by the sympathetic nervous system. Therefore,the effect of dexmedetomidine to the stress of pituitrin in laparoscopic hysteromyoma surgery is worth to be studied.

NCT ID: NCT03450421 Not yet recruiting - Uterine Fibroid Clinical Trials

Safety and Efficacy of Actamax™Adhesion Barrier in Women Undergoing Laparoscopic Abdominopelvic Surgery/Myomectomy

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

Women undergoing laparoscopic abdominopelvic surgery with a planned, second look laparoscopy within 8-12 (+4) weeks will be enrolled. All subjects must undergo myomectomy with/without treatment of co-existing pathology e.g. (+/-) adhesions and/or (+/-) endometriosis, and/or (+/-) adenomyosis, and/or (+/-) ovarian cyst(s). The value of the second look laparoscopy (SLL) must be confirmed by the investigator to be of clinical benefit to the subject. The subject must be desirous of future fertility and willing to undergo the SLL to assess whether pathology (e.g. adnexal adhesions or endometriosis) exists which could be treated with a goal of improving their likelihood of conceiving and progressing to full term.

NCT ID: NCT03219385 Not yet recruiting - Uterine Leiomyoma Clinical Trials

Directed Ablation of Uterine Fibroids Using a Noninvasive Approach

DIANA
Start date: September 2018
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to assess the safety and effectiveness of the Mirabilis System for treating uterine fibroids in women who are seeking relief from fibroid-related abnormal uterine bleeding but want to avoid hysterectomies or other surgical procedures. The Mirabilis System is an investigational device that delivers high-intensity focused ultrasound (HIFU) to the uterus using integrated ultrasound imaging guidance to offer noninvasive treatment for uterine fibroids. With the Mirabilis System, HIFU is applied noninvasively through the skin using an applicator that is placed against the abdomen. No incisions or surgical procedures are required. During this study, eligible patients will have one or more fibroids treated with the Mirabilis System and will then remain in the study for a total of 36 months after treatment to monitor the occurrence of adverse events. Primary endpoints will be assessed at 12 months after treatment, while secondary endpoints will be assessed at variable times ranging from immediately after treatment up to 36 months after treatment.

NCT ID: NCT02884960 Not yet recruiting - Uterine Fibroids Clinical Trials

Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization

Start date: October 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of Embozene Microspheres compared with Embosphere Microspheres for the treatment of symptomatic uterine fibroids. A total of 118 patents with symptomatic uterine fibroids will be enrolled at 6 sites. Symptom severity, health-related quality of life, and the appearance of the fibroids will be assessed prior to treatment. Patients will then undergo the uterine fibroid embolization procedure with either Embosphere Microspheres or Embozene Microspheres, which will be randomly assigned. Clinical outcomes will be assessed 1 month, 3 months, 6 months and 12 months after the procedure, and imaging outcomes will be obtained 3 months after the procedure.