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Recurrent Pregnancy Loss clinical trials

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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: NCT04621773 Active, not recruiting - Clinical trials for Recurrent Pregnancy Loss

Live Birth Rate in Patients With Unexplained Recurrent Pregnancy Loss

Start date: September 1, 2020
Phase:
Study type: Observational [Patient Registry]

STUDY AIM: to study the pregnancy outcomes and offspring development of patient with Unexplained Recurrent Pregnancy Loss Treated by PGS and spontaneous pregnancy, and to compare the health economic indicators and patient satisfaction of the two modes of pregnancy, so as to better guide the clinical treatment.

NCT ID: NCT04455256 Completed - Clinical trials for Recurrent Pregnancy Loss

Evaluation of Endoplasmic Reticulum Stress in Patients With Recurrent Pregnancy Loss

Start date: March 20, 2020
Phase:
Study type: Observational

To evaluate endoplasmic reticulum stress in women with recurrent pregnancy loss and those who had healthy births in the same age group. The level of the unfolded protein X box binding protein 1 (XBP-1) is measured. It is aimed to show the effect of endoplasmic reticulum stress on recurrent pregnancy loss.

NCT ID: NCT04397042 Suspended - Clinical trials for Recurrent Pregnancy Loss

SCUBE-1 and Carotid Intima Media Thickness in Recurrent Pregnancy Loss

Start date: May 22, 2020
Phase:
Study type: Observational [Patient Registry]

Clinical research will be carried out on two groups of patients. It will be performed on people with recurrent pregnancy loss and without a history of pregnancy loss. In two groups, blood samples will be assessed by elisa test, SCUBE-1 level and carotis intima media thickness will be evaluated by ultrasonographic measurement. It will be investigated whether there is a statistically significant difference between the two groups.A statistically significant difference in SCUBE-1 and carotid intima media thickness known as ischemia markers is expected in the group with recurrent pregnancy loss that could not be explained in the hypothesis of this planned study.

NCT ID: NCT04017754 Completed - Clinical trials for Pregnancy Complications

Low Plasma Mannose Binding Lectin (p-MBL) Level is a Risk Factor for Recurrent Pregnancy Loss (RPL)

Start date: January 1, 2016
Phase:
Study type: Observational

The present study is based on the hypothesis, that recurrent pregnancy loss (RPL) is associated with abnormal plasma mannose binding lectin (p-MBL) level. Secondarily, p-MBL level may affect the reproductive and the perinatal outcome in the first pregnancy following RPL. Thus, the present study aim to examine whether MBL should be a biomarker for women at risk for RPL and, secondarily, affect the reproductive and perinatal outcome, and thereby help clinicians identify fragile women who need intensified perinatal care.

NCT ID: NCT03905395 Recruiting - Clinical trials for Recurrent Pregnancy Loss

Meditation and Mindfulness for Recurrent Pregnancy Loss

Start date: February 2, 2019
Phase: N/A
Study type: Interventional

In the Danish Recurrent Pregnancy Loss Unit in Rigshospitalet in Copenhagen recurrent pregnancy loss (RPL) is defined as three og more consecutive pregnancy losses in accordance with current European guidelines. RPL affects approximately 3% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth. 42% of the women referred to RPL Unit in Rigshospitalet has a high stress level where as it's 22% in the background population trying to achieve parenthood. It's also known that 8,8 % of RPL patients have a depression at referral where as it's 2,2 % in the background population trying to achieve parenthood. The study is a RCT including 62 patients - 31 in each arm. One arm will be taught in meditation and mindfulness three courses over a 7 week period. This group will also do meditation every day for 7 weeks. The other arm will have no intervention. This study will investigate if a 7 weeks course in meditation and mindfulness is a useful tool to reduce stress and the psychological consequences for women and their partner treated in RPL Unit in Rigshospitalet, Copenhagen. Furthermore this study will investigate if there's a marital benefit such as reinforcement in their relationsship from practicing meditation and mindfulness. There is no previous study that has investigated meditation and mindfulness for RPL. This study has the potential to establish mental health support as a supplement to the medical and clinical treatment for RPL patients.

NCT ID: NCT03690830 Not yet recruiting - Clinical trials for Recurrent Pregnancy Loss

Use of Metabolomics for the Identification of Endometrial Biomarkers for IRPL and RIF After in Vitro Fertilization

ENDOMETAB
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

It is a case-control study composed of 3 groups : 2 cases groups (RIF and IRPL) already composed as part of a pre-existing research project and 1 control group including patients undergoing ART for male factor infertility. The purpose of this study is to compare the 2 case group with the control group to identify metabolomics signatures.

NCT ID: NCT03671174 Recruiting - Clinical trials for Recurrent Pregnancy Loss

Immunosuppressant Regimens for Living Fetuses Study

Start date: August 2, 2019
Phase: N/A
Study type: Interventional

Undifferentiated connective tissue diseases (UCTD) are known to increase the risk of pregnancy morbidities, including recurrent pregnancy loss. However, there is no consensus or guideline about the treatment for recurrent pregnancy loss in UCTD patients. Therefore, based on the tendency to thrombosis formation and placental inflammation in the pathogenesis of UCTD, this trial proposes to evaluate the effect of hydroxychloroquine with or without prednisone combined with anticoagulation on pregnancy outcomes in recurrent pregnancy loss patients with UCTD.

NCT ID: NCT03401918 Completed - Clinical trials for Recurrent Pregnancy Loss

Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility

Start date: August 1, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if patients with recurrent pregnancy loss or unexplained infertility have an altered uterine gene expression or uterine microbiome (micro-organism composition) during the window of embryo implantation. Furthermore we would like to assess for women with an abnormal uterine gene expression whether vaginal progesterone medication improves or alters gene expression and for women with an abnormal microbiome whether antibiotic treatment followed by probiotic treatment normalizes the microbiome.

NCT ID: NCT03305263 Recruiting - Clinical trials for Recurrent Pregnancy Loss

Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss

Start date: January 25, 2018
Phase: Phase 3
Study type: Interventional

Recurrent pregnancy loss (RPL) defined as 3 or more pregnancy losses affects approximately 3% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the chance of a live birth. Exciting indications for using Hydroxychloroquine (HCQ) include: Malaria profylaxis and treatment, systemic and discoid lupus erythematosus (SLE) and rheumatoid athritis (RA). HCQ has been reported to have the following properties (anti-thrombotic, vascular-protective, immunomodulatory, improving glucose tolerance, lipid-lowering, and anti-infectious). There is no data concerning the benefit of HCQ in RPL. Administration for other indications provides extensive safety data during pregnancy. This study has the potential to establish support for a new treatment option for unexplained RPL.