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Miscarriage clinical trials

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NCT ID: NCT05969574 Recruiting - Infertility, Female Clinical Trials

Is Decreased Ovarian Reserve Related to an Increased Number of Previous Early Miscarriages?

Start date: September 9, 2023
Phase:
Study type: Observational

This study aims to explore the potential correlation between decreased ovarian reserve and previous history of early miscarriage.

NCT ID: NCT05789940 Recruiting - Miscarriage Clinical Trials

Hysteroscopy vs. Endouterine Aspiration in the Management of Trophoblastic Retention

HARET
Start date: September 18, 2023
Phase: N/A
Study type: Interventional

Introduction: Incomplete early miscarriage is defined as early miscarriage with persistent intrauterine material on ultrasound. Intrauterine retention of trophoblastic debris is not an uncommon phenomenon. These retentions may initially be asymptomatic but are often responsible for persistent metrorrhagia and endometritis. This symptomatology often accentuates the psychological distress of patients mourning the pregnancy. Incomplete miscarriages are mainly managed by the gynecological emergency department. The recommendations of the Collège National des Gynécologues et Obstétriciens Français (CNGOF) suggest as a first line of treatment: either surgical management or expectant care. The choice between the two is left to the discretion of the doctor and the patient. there are no clear recommendations as to the choice between hysteroscopy and aspiration. Within the teams, the choice is often made according to the habits and protocols of the service, according to the equipment available and the skills of the gynaecologists. Aim: The main objective is to compare the efficacy of management by endo-uterine aspiration vs. management by hysteroscopy of trophoblastic retention after early miscarriage, at 6 weeks after surgery, by endovaginal ultrasound. Methods: This is a prospective, multicenter, randomized, open-label, two-arms, parallel therapeutic clinical trial comparing hysteroscopy versus endouterine aspiration for the management of trophoblastic retention after spontaneous miscarriage. Patients will be randomized (110 per arm) after verification of eligibility criteria and signature of consent, on the day of the operation: - Arm A: 110 patients treated by operative hysteroscopy - Arm B: 110 patients treated by endo-uterine aspiration

NCT ID: NCT05762770 Recruiting - Infertility Clinical Trials

A Trial of Sperm Injection (PICSI) on Miscarriage Rates in Assisted Conception

PICSI
Start date: March 27, 2023
Phase: N/A
Study type: Interventional

Physiological intracytoplasmic sperm injection (PICSI) is a technique used to select healthy, mature sperm for use in infertility treatment based on their physiological ability to bind to hyaluronan (HA), a natural compound found in the body. The relationship between sperm and hyaluronan can be used a marker of sperm maturity and optimal fertilising potentialÍž this principle can be observed in vitro using a PICSI sperm selection device. The PICSI Dish contains microdots of hyaluronan, which only mature sperm bind to and these are selected by the embryologist prior to use in the intracytoplasmic sperm injection (ICSI) procedure. Recurrent miscarriages following infertility treatment are mainly idiopathic, but can be linked with increased chromosomal abnormalities. PICSI has been shown to result in better embryo development and reduced chromosomal abnormalities, due to selection of mature sperm with low DNA damage. Therefore, PICSI may be a useful tool for reducing the rate of miscarriage following infertility treatment. The recent HABSelect study investigated treatment outcomes following PICSI, and whilst they concluded no effect on livebirth rate, they found a significant association in their secondary analysis between PICSI and reduced miscarriage rate compared to ICSI. The implications of the HABSelect study deserve to be explored further with miscarriage rate assessed as a primary outcome measure. This proof-of-concept randomised-controlled-trial aims to investigate whether PICSI shows some promise that would merit evaluation in a fully-powered trial to assess its efficacy as an advanced sperm selection method for the reduction of miscarriage rate. Eligible study participants will be patients undergoing fertility treatment using ICSI, who have provided consent for PICSI. Patients will be randomly allocated to two groups: the control group will receive ICSI according to standard protocol, and the intervention group will have additional sperm selection by HA-binding in a PICSI dish.

NCT ID: NCT05725512 Recruiting - Fertility Disorders Clinical Trials

Prednisolone Administration in Patients With Unexplained REcurrent MIscarriages

PREMI
Start date: January 29, 2024
Phase: Phase 2
Study type: Interventional

Recurrent miscarriages (RM) affects 3% of all fertile couples, but remains unexplained in most cases, limiting therapeutic options. Possibly the maternal immune system plays a role in recurrent miscarriage. Prednisolone suppresses the immune system and might enable development of normal pregnancy. In this randomized controlled clinical trial the investigators will study the effect of prednisolone on the live birth rate in patients with RM. Secondary, the tolerability and safety for mother and child and the cost-effectiveness is investigated. In the study one group of pregnant women with RM and gestational age <7 weeks will receive prednisolone, the other group will receive a placebo. Total use of the medicine during this study is 8 weeks, further care during the study is routinely antenatal care. Subjects will be asked to fill in 4 short questionnaires and will have contact with a research nurse at different time points to gain information on the course of the pregnancy and possible side effects. Results of the study will be implemented in (inter) national guidelines, to effect everyday practice.

NCT ID: NCT05492708 Recruiting - Pregnancy Related Clinical Trials

The Heartland Study

Start date: January 11, 2020
Phase:
Study type: Observational

The Heartland Study is a prospective, observational study that will enroll up to 2,600 pregnant participants across the Heartland States in the U.S.. The objective of the Heartland Study is to address major knowledge gaps concerning the health effects of herbicides on maternal and infant health. The study is being conducted to evaluate the associations between environmental exposures to herbicides during and after pregnancy and reproductive health outcomes. The study is measuring multiple biomarkers of herbicide exposure among pregnant Midwesterners and their partners to evaluate associations with pregnancy and childbirth outcomes, epigenetic biomarkers of exposure, and child development.

NCT ID: NCT05304273 Recruiting - Miscarriage Clinical Trials

Comparison Between Letrozole and Mifepristone in Medical Termination of First Trimester Miscarriages

Start date: May 5, 2022
Phase: Phase 3
Study type: Interventional

Prospective interventional study where participants with non-viable pregnancy at 1st trimester will be randomized into two arms, one group will receive conventional treatment with oral mifepristone followed by misoprostol vaginally and another group will receive letrozole for three consecutive days followed by misoprostol vaginally in an attempt to terminate the pregnancy medically. Mean duration of induction to expulsion of product of conception and rate of complete abortion will be compared in two groups.

NCT ID: NCT04797338 Recruiting - Miscarriage Clinical Trials

Gonadotropin Releasing Hormone Agonist (GnRHa) Versus Estrogen and Progesterone for Luteal Support in High Responders

Start date: December 29, 2017
Phase: Phase 4
Study type: Interventional

Gonadotropin Releasing Hormone agonist (GnRHa) triggering is used as an alternative to human chorionic gonadotropin (hCG) in GnRH antagonist protocol to eliminate the risk of ovarian hyperstimulation syndrome (OHSS). However, its main disadvantage is a significantly lower pregnancy rate, hypothesized to result from a process called "luteolysis" (demise of the corpora lutea). In order to preserve a high pregnancy rates, several luteal support regimens were investigated, including an intensive estrogen and progesterone supplementation and a daily GnRHa treatment. However, no study, so far, compared the efficacy of these two regimens. Our aim is to compare the efficacy of GnRHa versus estrogen and progesterone supplementation for luteal phase support in high responders following GnRHa triggering.

NCT ID: NCT04701034 Recruiting - Fertility Disorders Clinical Trials

Intravenous Immunoglobulin and Prednisolone for RPL After ART.

RPL
Start date: February 6, 2021
Phase: Phase 2
Study type: Interventional

Recurrent pregnancy loss (RPL) affects around 5 % of women in reproductive age. The underlying cause of RPL is most often unknown, probably multifactorial, and no treatment with documented effect on chance of live birth exists. In unexplained cases of RPL, primarily the immune system is hypothesized to play a pivotal, causative role, since autoantibodies and specific human leukocyte antigen (HLA) alleles as well as unbalanced distribution of leucocyte subsets, especially natural killer (NK) cells and T-helper (Th) cells, occurs more frequently in patients with unexplained RPL. For that reason, many treatment regimens used in autoimmune diseases have been tested on RPL patients, as for example prednisolone and intravenous immunoglobulin (IVIg). IVIg (Privigen) consist of a broad spectrum of structurally and functionally intact IgG antibodies. The mechanism of action is not fully elucidated, but certainly IVIg do help opsonise and neutralize foreign cells and pathogens. Prednisolone support this anti-inflammatory action by suppressing migration of polymorphonuclear leukocytes, and reducing the volume and activity of the immune system and the capillary permeability. A retrospective, observational pilot study suggested that a combination of prednisone and IVIg in first trimester improves the chance of a live birth in women with RPL after assisted reproductive technologies (ART) (Nyborg et al., 2014). A randomized controlled study is necessary for determining if this immunomodulatory treatment definitely is effective in patients with unexplained RPL after ART (defined as IVF or ICSI ad FER). Potentially, this study will be able to establish evidence for an effective treatment to women with unexplained RPL after ART, who otherwise have a poor prognosis.

NCT ID: NCT04699578 Recruiting - Covid19 Clinical Trials

COVID-19 Infection and Fetal-neonatal Outcomes

Start date: December 28, 2020
Phase:
Study type: Observational

COVID-19, the coronavirus responsible for the pandemic that began at the end of 2019 in China, spreads through respiratory droplets and direct contact. The most common symptoms of the disease include fever, cough, asthenia or myalgia, wheezing and headache, and the most serious complication is acute respiratory distress syndrome (ARDS). The new coronavirus has continued to spread to multiple countries and continents so much so that the epidemic was declared a Public Health Emergency of International Interest (PHEIC) by the World Health Organization (WHO) on January 30, 2020. In the first phase of emergency worldwide, characterized by high morbidity and mortality, scientific interest has been mainly directed to the study of the transmission mechanisms of the infection, diagnostic tools and therapies for ARDS, especially in elderly and co-morbid patients. Interest has rapidly spread to other categories of patients and in particular to pregnancy, on which the virus could impact in different ways, with consequences for both the mother and the fetus. A recent systematic review that included all published reports on Coronaviruses (COVID-19, SARS, and MERS) in pregnancy showed that preterm delivery is the most frequently reported adverse event in these women, and that COVID-19 is associated with an increased risk of preeclampsia and caesarean section. Nonetheless, the limited sample size, the main inclusion of cases reported for acute respiratory symptoms, the lack of information on previous pathologies potentially capable of complicating pregnancy, do not allow for the extrapolation of strong evidence on the course of infection in pregnancy. Therefore, the current status of the scientific literature does not allow for general and wide-ranging implications. THe investigators therefore believe it is particularly useful to investigate maternal and fetal outcomes in this new broader scenario, including all pregnancies associated with asymptomatic or symptomatic SARS-CoV-2 infection, found in any gestational period, in order to evaluate in a "real world scenario" "Actual rates of maternal-fetal and neonatal adverse events

NCT ID: NCT04466956 Recruiting - Miscarriage Clinical Trials

Virtual Reality in MVA for Miscarriage

Start date: July 1, 2021
Phase: N/A
Study type: Interventional

We are investigating the use of a virtual reality programme to reduce pain and anxiety experienced during manual vacuum aspiration. Virtual reality (VR) is the computer-generated simulation of a three-dimensional environment that can be interacted with in a seemingly real way by a person using special electronic equipment. In this study a VR headset is worn by the patient allowing them to experience a relaxing environment whilst the procedure manual vacuum aspiration (MVA) is performed. VR is mostly used in computer gaming but has uses in medical field and has been used in the treatment of long standing pain, treatment of burns, dentistry and treatment of cancer pain. However, its role in the management of pain and anxiety during gynaecological procedures like manual vacuum aspiration has not been researched. This study explores whether it has a place in the treatment of gynaecological pain and reduction of anxiety.