Active clinical trials for "Gynatresia"

Since the development in the last few years of the bipolar energy in the surgery by hysteroscopy, the hysteroscopic treatment of the submucosal uterine myoma can be performed by use of either monopolar or bipolar current. It seems that the use of the bipolar energy decreases the rate of adhesions but prospective data on the adhesion rate and fertility after the use of bipolar energy during the surgery are poor, and there is currently no recommendation as to the choice of technique to use. The main purpose of this study is to compare the rate of uterine adhesions six weeks after the surgical hysteroscopic treatment of uterine submucosal myoma, by using monopolar or bipolar energy. The pregnancy and spontaneous miscarriage rate will also be evaluated.

This project aims to investigate the safety and effectiveness of human amniotic epithelial cells in the treatment of the severe refractory Asherman's syndrome.

Only patients who sign an informed consent will be included. Patients after a miscarriage in the 2nd trimester of pregnancy who need to perform an instrumental revision of the uterine cavity (RCUI, revisio cavi uteri instrumentalis) will be randomized into two groups. In the first group, RCUI will be performed according to current standards. In the second group, an anti-adhesive preparation with hyaluronic acid (Hyalobarrier gel Endo) will be applied to the uterine cavity at the end of the RCUI procedure. Eight to twelve weeks after the operation, the occurrence of adhesions will be evaluated by ultrasound examination and diagnostic hysteroscopy (if adhesions will be detected, they will be disrupted). The study will also include the completion of a questionnaire in terms of the frequency and strength of the menstrual cycle. The presence of adhesions will be assessed according to The American Fertility Society (AFS).

The endometrium is a tissue with high capacity of renewal ("self-renewal"). This process is regulated by stem cells. Recent studies have shown that bone marrow-derived stem cells (BMDSCs) contribute to tissues and organs regeneration, including the murine and human endometrium. Additionally, BMDSCs have the ability to differentiate into functional endometrial and stromal epithelial cells. Asherman's Syndrome (AS) also referred to as intrauterine adhesions (AIU), is an acquired uterine condition characterized by the formation of adhesions inside the uterus. In many cases the front and back walls of the uterus stick to one another. Most patients with AS have menstrual abnormalities, pelvic pain, recurrent miscarriage, and infertility, and psychological disorders. Currently, hysteroscopy is considered the gold standard of methods for the diagnosis of intrauterine adhesions. However, it has a limited capacity for treatment, especially in moderate or severe cases in which permanent infertility can occur. For the first time, our investigation group demonstrated the possibility of regenerating endometrial tissue through bone marrow-derived stem cells (Santamaria et al., 2016). This project aims to determine the safety, tolerability and biodistribution of IGX1 (CD133+ cells selected after mobilization and collection of peripheral blood progenitor cells - CPSP) afte rthe intraarterial injection in rats with induced Asherman's Syndrome. Therefore, the focus of this project is to satisfy the preclinical requirements set out by the the AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) in relation to the Phase I/II clinical trial "Phase I-II clinical trial of advanced, prospective, open, non-randomized, uncontrolled (before-after study), explanatory, multicentre cell therapy , national, intervention with a single treatment group in patients of reproductive age with gestational desire diagnosed with Asherman's Syndrome grade II, III or IV, treated by autologous non-expanded bone marrow stem/progenitor cells selected (IGX1)" (IGX1-ENT-XS-16-01)

Asherman syndrome, which occurs after trauma to the basalis layer of the endometrium.It seems that the role of postoperative estrogen therapy in the prevention of recurrence of IU adhesions is still controversial. To investigate if estrogen therapy can prevent adhesion reformation after adhesiolysis. After the completion of hysteroscopic adhesiolysis, recruited patients will be randomized to one of the two treatment groups by computer-generated numbers: having estrogen after hysteroscopic adhesiolysis three months, all patients in this group will be treated with hormone therapy for 3 cycles; each cycle consists of estradiol 4mg per day for 21 days with addition of progestogen in the form of dydrogesterone 10mg per day for the last 7 days; and the control group without estrogen treatment. A second-look hysteroscopy and ultrasound assessment of the endometrium will be carried out 4 weeks after the surgery, and again at 8 weeks after the surgery.

The study purpose is to examine the influence of INTERCOAT in prevention of intra-uterine adhesions formation after any hysteroscopic surgery.

Utilising a novel pre-surgical grading system to class cases of asherman syndrome into 3 groups based on expected difficulty of surgery and potential prognostic outcomes.