Clinical Research Directory

A Prospective Multicenter Observational Real-world Study of Retained Products of Conception

The purpose of this study is to explore the optimal treatment strategy for retained products of pregnancy. Compared with surgical treatment, prospectively observe whether drug-assisted expectant management until the right time for surgery reduce the occurrence of intrauterine adhesions, and thus protect fertility.

Intracervical Vasopressin

This randomized study looks at whether using a medicine injected into the cervix of the uterus (intracervical), called vasopressin, helps to achieve better removal of retained products of conception (RPOC). RPOC means that after a pregnancy has ended (through miscarriage, abortion, or delivery), some parts of the pregnancy tissue, usually from the placenta or fetus, have stayed in the uterus. A hysteroscopic removal of RPOC is one type of treatment. This is a surgical procedure where a doctor uses a small camera attached to a thin tube (called a hysteroscope) to look inside the uterus. The main goal of the study is : • To add to the existing research through this study to see if the injection of intracervical vasopressin leads to improved completion rates of hysteroscopic management of RPOC. Participants will: • would be randomized to receive either vasopressin intracervical injection or a placebo injection (non-active saline) during your procedure. Information from the procedure will be collected from the participant's medical record.

Comparison of Operative Hysteroscopy Performed in the Operating Room Versus Outpatient Settings

This is an observational prospective monocentric study which aims to compare operative hysteroscopies performed in the operating room under general or loco-regional anesthesia and those performed outside the operating room (outpatient operative hysteroscopy). The primary outcome is the success rate of the procedure. Secondary outcomes include postoperative pain, patient satisfaction, complications, and time to return to work.

Use of Nitrous Oxide During Office Hysteroscopy

The goal of this clinical trial is to assess the use of inhaled nitrous oxide during office hysteroscopy. The main questions it aims to answer are: * Does it reduce pain during the procedure? * Does it increase the success rate? * Does it improve patient satisfaction? * Does it reduce anxiety? * Which populations benefit more (e.g., parity, menopausal status, number of previous surgeries, type and duration of procedure, and type of device)? Participants will be asked about their pain levels during the procedure, as well as their anxiety levels. All responses will be recorded. Written informed consent will be obtained prior to initiation.

A Prospective Study Evaluating the Impact of Conservative Management on Retained Products of Conception and EMV

The goal of this observational study is to learn about the therapeutic effects of the conservative treatment approach on pepole with retained products of conception (RPOC) and Enhanced myometrial vascularity (EMV). The main question it aims to answer is: Is it possible to achieve the natural resolution of RPOC by combining it with EMV through conservative treatment？ Participants will receive conservative treatment (such as mifepristone, GnRH-a, or expectant management) following the initial diagnosis of RPOC and EMV, and the therapeutic efficacy of the conservative approach will be assessed after the completion of two menstrual cycles.

The Efficacy of Auto-cross Linked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception

Retained product of conception (RPOC) is defined by abnormal trophoblastic persistence or retained placenta inside the uterus cavity after a pregnancy independently of the outcome. Untreated RPOC can compromise future fertility. RPOC are generally treated surgically, either by repeated evacuation or by hysteroscopy, which exposes the uterus to additional potential trauma.The combination of trauma to the gravid uterine cavity, hypoestrogenic state at the time of the operation or immediately afterward and local infection is considered to be the pathogenic mechanism of intrauterine adhesions (IUA) , manifested clinically by menstrual abnormalities, infertility and recurrent pregnancy loss.To investigate the efficacy of auto-cross linked hyaluronic acid gel in the prevention of adhesion reformation after hysteroscopic resection of retained products of conception. After the completion of hysteroscopic resection of retained products of conception, patients will be randomized to one of the two groups by computer-generated numbers: \[1\] infusing auto-cross linked hyaluronic acid gel into intrauterine cavity in the experimental group; \[2\] no auto-cross linked hyaluronic acid gel into intrauterine cavity in the control group. Second and third look outpatient hysteroscopy will be performed 4 and 8 weeks after the initial surgery. The patients will be followed up about menstrual pattern at 3 months after the surgery.The patients will be followed up about pregancy outcome at 12 months after the surgery.

Impact of Different Saline Pressures During Hysteroscopy on Visibility, Feasibility and Patients' Discomfort

Hysteroscopy is a minimally invasive diagnostic and therapeutic procedure for various intrauterine conditions. It is performed with an optic device while entering liquid media to the uterus to allow visualization. Diagnostic procedures are often performed without anaesthesia (in the office setting) and operative procedures are performed either under general anaesthesia or without anaesthesia (in the office setting). It depends on the patients' characteristics and preferences, and surgical indications. 80%-100% of operative procedure without anesthesia can be successfully completed. The main reasons for inability to successfully complete operative hysteroscopy without anesthesia are patients' discomfort and limited visibility of the uterine cavity. In the current study, the investigators will compare the use of two different pressure setting of the liquid media during operative hysteroscopy without anesthesia, with the aim of investigating the successful completion of the procedure and patient's discomfort, with the aim of determining the optimal pressure setting.

HYALOBARRIER® GEL ENDO Versus no HYALOBARRIER® GEL ENDO Following Operative Hysteroscopy for Improving Reproductive Outcome in Women With Intrauterine Pathology Wishing to Become Pregnant

To compare the costs and effects of HYALOBARRIER® GEL ENDO versus no HYALOBARRIER® GEL ENDO for increasing the chance of conception leading to live birth measured at 30 weeks after randomization in women wishing to become pregnant after surgical removal of intrauterine pathology (endometrial polyps, fibroids with uterine cavity deformation, uterine septa, IUAs or RPOC after miscarriage) by hysteroscopy as an outpatient or in hospital treatment.

Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.

Rationale: Elective immediate dilation and curettage (D\&C) for miscarriage is associated with the occurrence of intrauterine adhesions (IUA). IUAs may be associated with subsequent subfertility and premature birth. Recent studies have shown that in women with miscarriage, medical treatment (misoprostol/mifepristone) is an effective alternative for curettage. A problem with medication and expectant management is that after initial treatment, sonographic findings during follow-up frequently show incomplete evacuation of uterine retained products of conception (RPOC), which often lead to additional interventions or expectant time-consuming management limiting the benefits of medical treatment. Objective: To assess, in women with a wish for immediate future pregnancy and RPOC after non-surgical management of a miscarriage, as diagnosed with sonography, the effects of operative hysteroscopy versus expectant management. Study design: Multicenter randomized clinical trial. Study population: Patients after non-surgical management of a miscarriage with sonographic evidence of RPOC at the follow-up visit 6 weeks after initial treatment and wish for immediate (within 6 months) future pregnancy. Intervention: operative hysteroscopy versus expectant management. Main study parameters/endpoints: The primary outcome is time to next pregnancy, as substantiated by a positive urinary or serum hCG test. Secondary outcomes are Quality of Life (QOL) scores assessed with the SF-36, HADS and EQ-5D-5L, the need for additional and/or unscheduled treatments and/or visits and complications. Furthermore, data on the course of pregnancy - including miscarriage, ectopic pregnancy and live birth - are documented in those women who have an ongoing pregnancy after randomization during the study follow up period. In addition, iMTA PCQ questionnaires and health-costs are measured in all patients to perform a cost-effectiveness analysis. A total of 244 (122 per arm) women will be sufficient to answer the questions on the primary endpoint. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Women participating in the study will be asked to fill out questionnaires at baseline, 8 weeks and 6 months after randomization. We don not expect specific risks as a result of either the intervention or expectant management.