Treatment Trials

11 Clinical Trials for Various Conditions

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Tender Loving Care for Recurrent Pregnancy Loss
Description

The goal of this investigational study is to evaluate participation in a weekly, interactive, tender loving care messaging platform impact on pregnancy outcomes in patients with recurrent pregnancy loss. The main questions it aims to answer are: (1) does participation in weekly, interactive tender loving care messages increase live birth rates in patients with recurrent pregnancy loss? (2) Does participation in weekly, interactive tender loving care messages increase patients' quality of life? Does participation in weekly, interactive tender loving care messages decrease patients' depressive symptoms? Participants will be asked to interact with weekly messages providing prenatal counseling and support. Additionally, patients will be asked to complete the fertility quality of life survey several times over the course of the pregnancy.

Conditions

Recurrent Pregnancy Loss

Genomic Predictors of Recurrent Pregnancy Loss
Description

The overall goals of this proposal are to determine the genetic architecture of recurrent pregnancy loss (RPL) and to discover genomic predictors of RPL.

Conditions

Recurrent Pregnancy Loss

Assessing the Endometrial Environment in Recurrent Pregnancy Loss and Unexplained Infertility
Description

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.

Conditions

Recurrent Pregnancy Loss, Unexplained Infertility

Hydroxychloroquine (HCQ) for Recurrent Pregnancy Loss
Description

Recurrent pregnancy loss (RPL) affects 5% of couples trying to achieve parenthood. Most cases of RPL are unexplained and have no effective treatment to improve the likelihood of a pregnancy resulting in a live birth. This leads to significant patient and provider frustration and emotional stress. Hydroxychloroquine (HCQ) is a medication commonly used in pregnancy to treat autoimmune and connective tissue diseases such as systemic lupus erythematosus (SLE). This use has shown that HCQ is very safe in pregnancy. HCQ has anti-inflammatory and anti-thrombotic effects and thus may improve pregnancy outcomes in couples with unexplained RPL. Although some providers are already prescribing HCQ for unexplained RPL, a randomized controlled trial is necessary to determine the true efficacy and safety of this treatment. This study has the potential to establish support for a new treatment option for unexplained RPL.

Conditions

Recurrent Pregnancy Loss, Miscarriage

Efficacy of a Structured Weight Loss Program in Overweight Women With a History of Recurrent Pregnancy Loss
Description

Overweight and obesity has been associated with a number of adverse pregnancy outcomes in women of reproductive age, including infertility and early pregnancy loss. Recent data suggests that overweight and obese patients are also at increased risk of recurrent pregnancy loss (RPL), a devastating condition that affects 1% of the fertile population. The investigators propose a prospective, randomized controlled trial in which overweight and obese patients with unexplained recurrent pregnancy loss are enrolled in a structured, 6 month, weight loss program or provided routine counseling regarding the importance of weight loss. Pregnancy outcomes will then be followed to assess miscarriage rates. Metabolic outcomes, such as lipid and glucose profiles, will also be evaluated.

Conditions

Obese, Overweight, Miscarriage, Recurrent Pregnancy Loss

Pharmacokinetics of Low Molecular Weight and Unfractionated Heparin in Pregnancy
Description

To determine, through pharmacokinetic parameters, the ideal dosing protocol for dalteparin (a low molecular weight heparin) and unfractionated heparin for women desiring pregnancy who have evidence of an acquired (specifically, antiphospholipid syndrome) or inherited thrombophilia.

Conditions

Recurrent Pregnancy Loss, Fetal Demise, Abortion, Habitual, Antiphospholipid Antibodies, Inherited Thrombophilia

Microfluidics Versus Gradient Centrifugation Effect on Euploidy Rates
Description

This research is being done to determine if using a microfluidics chamber, a device used to process sperm, will be effective in improving the rates of embryos with normal chromosomes (structures that carry genetic information) during in vitro fertilization (IVF) treatment. The investigators hypothesize that this device is effective at improving rates of normal chromosomes among embryos.

Conditions

Infertility, Recurrent Pregnancy Loss

Comparison of Standard ART Practice vs. Trophectoderm Biopsy and Whole Chromosome Analysis
Description

We propose to perform a clinical randomized trial to evaluate the effect of blastocyst biopsy and whole chromosome analysis by Next Generation Sequencing (NGS) in comparison to standard Assisted Reproductive Technologies (ART) methods on on implantation rates, miscarriage rates, and pregnancy rates. This will be three studies into one: a) a comparison of treatment (NGS) and no treatment, b) a non-selection study based on the control group for which we will replace without knowing the ploidy of the embryos, but we will know it later, c) a retrospective study about the use of Mitochondrial DNA as a selection tool.

Conditions

Infertility, Recurrent Pregnancy Loss

Preimplantation Genetic Diagnosis Using Blastocyst Biopsy and Array CGH
Description

The investigators propose to perform a clinical randomized trial to evaluate the effect of single embryo (blastocyst) transfer (SET) with array CGH for the evaluation of the complete chromosome complement of the blastocyst in comparison to standard ART methods in which one or more embryo are replaced. Patients will be randomized into two groups: * Control group: patients will have up to two embryos replaced on day 5 based on morphological and developmental characteristics, and the other embryos reaching blastocyst stage will be vitrified. If patients in the control group do not have a pregnancy to term from that fresh cycle, they will be offered free PGD either for the frozen embryos of that cycle or for the next cycle (up to the center and patient). Data from that PGD is not part of the study. * Test group: patients will have grade A,B or C blastocysts hatched on day 5, biopsied on day 5, analyzed by array CGH, and a single euploid embryo transferred on day 6. Any morulas developing to grade A,B or C blastocyst on day-6 will be also analyzed but vitrified for use in a future cycle.

Conditions

Infertility, Recurrent Pregnancy Loss

Intravenous Immunoglobulin (IVIG) for Treatment of Unexplained Secondary Recurrent Miscarriage
Description

Recurrent miscarriage is a prevalent reproductive problem that affects many couples who are trying to establish a family. This clinical study will evaluate the effectiveness of intravenous immunoglobulin (IVIG) in improving the live birth rate in couples who suffer from secondary recurrent miscarriage. This study will help in providing an answer to the question of whether IVIG is helpful in secondary recurrent miscarriage.

Conditions

Miscarriage, Recurrent, Abortion, Habitual

Endometrial Basis for Infertility in Women With Recurrent Implantation Failure and Pregnancy Loss
Description

Background: Pregnancy loss is the most common complication of pregnancy. It occurs in roughly one-half of natural conceptions. It most frequently occurs in the first 2 to 3 weeks of pregnancy. Researchers want to look at the lining of the uterus, called the endometrium, to see what role it plays in implantation and miscarriage. Objective: To gain a better understanding of how normal and abnormal endometrium works. Eligibility: Healthy, fertile women ages 18-42 who have had one prior child. Design: Participants will have 3 study visits. At visit 1, participants will have a medical history. They will have a radiologic/imaging review if needed. They will be taught how to monitor their urine luteinizing hormone (LH) at home with an ovulation predictor kit. They will have their second study visit 9 days after their LH surge. At visit 2, participants will take a urine pregnancy test. They will have a physical exam and have blood drawn. They will have a uterine lavage and endometrial biopsy. For this, a speculum will be placed into the vagina. A soft catheter will be inserted through the cervical canal into the uterus. Saline will be added into the uterus and then recovered after 30 seconds. A tissue sample will be taken. About 46 days later, participants will start another round of LH monitoring. They will have a third study visit 9 days after their LH surge. At visit 3, they will repeat the tests from visit 2. Some samples will be used for genetic tests. Participation will last for 3 menstrual cycles. ...

Conditions

Normal Endometrial Physiology