Treatment Trials

65 Clinical Trials for Various Conditions

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TERMINATED
Prospective Assessment of Impact of Personalized Dosing of Low-dose Human Chorionic Gonadotropin (hCG) on in Vitro Fertilization (IVF) Outcomes
Description

The purpose of the study is to determine the effect of tailoring dosage of low-dose hCG secondary to serum hCG levels during IVF ovarian stimulation on sustained implantation rates of preimplantation genetically tested euploid embryos.

COMPLETED
Administration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles
Description

This is a randomized, double-blind, single center clinical trial study to compare oocyte competence and risk of ovarian hyperstimulation syndrome (OHSS) after receiving the standard dose of human chorionic gonadotropin (hCG) ovulation trigger or a lower dose of hCG plus concomitant follicle stimulating hormone (FSH) co-trigger in women undergoing in vitro fertilization (IVF).

Conditions
COMPLETED
Stress Management for Couples Undergoing In Vitro Fertilization (IVF)
Description

The investigators are trying to determine stress management strategies in couples undergoing In Vitro Fertilization (IVF).

Conditions
TERMINATED
Effect of Vitamin D Supplementation on In-vitro Fertilization (IVF) Outcomes
Description

Historically, vitamin D has been considered to play a role solely in bone and calcium metabolism. Numerous studies have suggested a link between vitamin D deficiency and adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. In the obstetrics literature, vitamin D deficiency has been linked to preeclampsia, gestational diabetes, and increased rate of cesarean section rate. Recent data from retrospective chart reviews have demonstrated a possible role of vitamin D in implantation and clinical pregnancy rates in patients undergoing in-vitro fertilization. Patients found to be deficient in vitamin D were found to have significantly lower clinical pregnancy rates when compared to patients who were replete in vitamin D levels. Currently, there are no prospective clinical trials investigating the effects of vitamin D supplementation on IVF outcomes such as clinical pregnancy rate and implantation rates. The investigators hypothesize that the vitamin D supplementation in patients found to be either deficient or insufficient in vitamin D will lead to improved pregnancy rates in infertility patients undergoing in-vitro fertilization.

COMPLETED
The Impact of Lifestyle Behavior on in Vitro Fertilization (IVF) Outcome
Description

The purpose of this study is to prospectively examine the impact of various lifestyle habits in both men and women on the outcome of in vitro fertilization. There are 25 infertility centers in the United States which use the electronic medical record collection entity eIVF, made by Practice Highway, to collect medical and demographic information on the patients who are undergoing treatment at these centers. Information on every aspect of each cycle is also electronically collected daily during each cycle. Demographic and lifestyle information will be collected on all patients prior to cycle start and lifestyle habit information will be collected each time a patient logs onto the patient portal, which averages every few days.

Conditions
COMPLETED
Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing In Vitro Fertilization (IVF)
Description

To assess the impact of embryo biopsy on the reproductive potential of human embryos.

WITHDRAWN
The Impact of an Online Stress Management Program on In Vitro Fertilization (IVF) Outcome
Description

The goal of this study is to determine the impact of an online stress management program, which combines stress reduction and prevention strategies with personal care products/rituals which have relaxation properties, on pregnancy rates and psychological distress in women undergoing IVF for the first time.

Conditions
COMPLETED
The Impact of Lifestyle Behaviors on In Vitro Fertilization (IVF) Outcome
Description

Many women undergoing in vitro fertilization (IVF) ask their doctor if there are any behaviors they should avoid, or any behaviors they should emphasize during their IVF cycle. This study examines the effects of health habits surrounding exercise, smoking, alcohol, sleep, caffeine, herbal medications, acupuncture, and diet on pregnancy rates during IVF cycles. The purpose of this study is to determine if lifestyle behaviors have a significant impact on pregnancy rates during treatment with IVF. This is an observational study conducted at a private academically-affiliated infertility clinic and includes 118 women ages 44 and below scheduled to undergo IVF treatment. All subjects were asked to complete a health history survey at the time of enrollment and a daily survey during each day of their IVF cycle. The primary outcome is clinical pregnancy rate.

Conditions
SUSPENDED
In Vitro Maturation With in Vitro Fertilization (IVF) Compared to Mild in Vitro Fertilization
Description

Methods of infertility treatment may involve in vitro fertilization or IVF. Though effective, IVF is complex and expensive. Methods using no gonadotropin hormone stimulation of the ovaries are being compared to mild stimulation doses. The goal of the research is to determine which of these if more suitable as a low cost approach for varying individual patients.

Conditions
COMPLETED
Subcutaneous Progesterone Versus Vaginal Progesterone Tablets for Luteal Phase Support in In Vitro Fertilization (IVF)
Description

Prospective, open, randomized, parallel, multicenter, two-arm trial to evaluate the efficacy and tolerability of a new progesterone formulation to be used for luteal support in IVF (Progesterone-IBSA) administered subcutaneously at a daily dose of 25 mg versus Progesterone tablets administered intravaginally at 100 mg twice daily for a total dose of 200 mg.

WITHDRAWN
Oral Microdose Lupron Versus Luteal Estradiol Trial in Poor Responder In Vitro Fertilization (IVF) Patients
Description

Hundreds of thousands of couples in the United States experience infertility each year. When initial measures do not help, some couples require a process called ovarian stimulation and in vitro fertilization (IVF). Usually, a woman produces at most one egg each month. Ovarian stimulation helps these women make more than one egg per month. However, this involves taking hormones that stimulate the ovary to produce many eggs at one time. The stimulatory hormones injected with a small needle. The eggs are removed from the ovary through a surgical procedure and then placed in a dish for fertilization by sperm to form embryos. The embryos are grown in the laboratory then replaced into the woman's uterus 3-5 days later. The stimulation of the ovaries is important. Some patients undergo ovarian stimulation for IVF but do not respond to the treatment. This is a very difficult situation because even though several ovarian stimulation protocols have been used for poor responder patients, it is not clear which protocol works best. In fact, two of the most commonly used protocols have not been directly compared. This study will randomize (like flipping a coin) couples with a history of low response who are going to start IVF treatment into two groups. In one group the female partner will use a protocol called "E2 patch/antagonist". These women will use an estrogen patch and injected antagonist for several days before starting injectable fertility medications. The other group will use a protocol called "OCP/microdose". This group of women will use oral contraceptive pills (OCPs) and small doses of lupron along with the other injectable fertility medications. We will then follow their progress to see how many eggs they produce and how many women get pregnant.

Conditions
TERMINATED
Use of Nitric Oxide Metabolites for Predicting Embryo Quality in In-Vitro Fertilization (IVF)
Description

Improvements in In-Vitro Fertilization (IVF) outcomes have largely been due to the generation of excess embryos allowing for multiple embryo transfer. Unfortunately this has also increased the risk of multiple pregnancy with associated maternal and neonatal morbidity and mortality. The investigators believe that the concentration of nitric oxide metabolites measured in the culture medium from the first day of culture can identify the best quality embryos allowing us to transfer a limited number of embryos without compromising the optimum chance for pregnancy.

Conditions
TERMINATED
In Vitro Fertilization (IVF) and Acupuncture for Infertility
Description

The aim of this investigation is to determine the value of combining acupuncture with infertility patients undergoing In Vitro Fertilization (IVF). The investigators will measure the outcomes of endometrial lining, uterine blood flow, hormones, stress levels, and pregnancy and live birth rates.

Conditions
COMPLETED
Communication With in Vitro Fertilization (IVF) Patients About Risks
Description

The primary objective of this trial is to determine whether written educational materials plus brief education by telephone will help patients better understand and participate in the decision on how many embryos to transfer to the uterus during treatment of infertility with in vitro fertilization (IVF). The main study hypothesis is that women and men who receive the study's educational intervention will experience favorable changes in knowledge and beliefs about benefits, susceptibility and severity of multiple gestation that impact decisions about the number of embryos to transfer. Secondary objectives are to understand patient beliefs, knowledge and information preferences regarding other possible risks of IVF, to compare perception of IVF-related risks to familiar risks that are included in routine preconception health promotion, and during IVF, and to prepare couples to manage IVF-related obstetrical risks when they make the transition to prenatal care after becoming pregnant. Medical Treatment Coverage: None, this study does not provide any monetary contribution to medical treatment

Conditions
COMPLETED
in Vitro Fertilization (IVF) Media Protein and Live Birth Rates
Description

Human conception in vivo occurs in a complex milieu that includes proteins. It has been speculated that the addition of proteins more complex than human serum albumin to culture media may improve IVF outcomes. Whether the expense, labor and risk of adding additional human-derived protein to IVF media are warranted is a question unanswered. Patients, undergoing routine IVF or ICSI, will be assigned to one of two treatment groups in a randomized, prospective clinical trial . Embryos will be cultured in either media supplemented with human serum albumin (HSA) as a solitary protein supplement or in media supplemented with HSA + SSS from the 2-PN stage until the time of embryo transfer. Clinical endpoints monitored will be implantation rate, clinical pregnancy rate and live birth rate. It is expected that the supplementation of commercial embryo culture media containing HSA with the more complex protein source, SSS, will result in an overall increase in implantation, clinical pregnancy, and live birth rates. In the balance, protein enrichment of media may represent opportunities to simultaneously increase the live birth rate and reduce the incidence of multiple gestations.

COMPLETED
Comparison of Crinone 8% Intravaginal Gel and IM Progesterone Supplementation for In Vitro Fertilization (IVF)
Description

The goal of this research study is to compare the pregnancy rates for two different types of progesterone supplementation after in-vitro fertilization (IVF).

Conditions
TERMINATED
A Trial of Dehydroepiandrosterone (DHEA) Treatment for in Vitro Fertilization (IVF)
Description

Our long term goal is to elucidate the role of DHEA on follicular dynamics in the human ovary and to better understand the interaction of DHEA supplementation with other treatments for ovulation induction, especially among older reproductive age women. The specific hypothesis behind the proposed research is that DHEA is a regulator of follicular dynamics acting in the early pre-gonadotropin dependent stage of initial primordial follicle recruitment and growth.

TERMINATED
Protocols for Improved in Vitro Fertilization (IVF) Outcomes
Description

Many infertile patients have a decreased chance of becoming pregnant when using in vitro fertilization (IVF). For these patients, many different treatments are available, but none of them have been shown to be better than the others. We are testing which of three different treatments are better than the others. Patients who are expected to have a decreased response to ovarian stimulation will be randomized to either a microflare protocol, an antagonist protocol, or a demi-halt protocol.

Conditions
COMPLETED
The Effect of Acupuncture on Infertility With In-Vitro Fertilization (IVF) Patients
Description

Infertility is a common problem with increased incidence. In-vitro fertilization (IVF) is by far the most commonly used treatment. The success rate of IVF is still low. This study examines the effect of acupuncture on IVF pregnancy rate, as well as possible mechanisms. It is hypothesized that acupuncture can significantly increase the IVF pregnancy rate.

Conditions
COMPLETED
Natural Cycle In Vitro Fertilization
Description

Natural IVF study patients will undergo an IVF cycle with trigger shots of Lupron \& hCG. Patients will not be given any other stimulating medications during the cycle. They will have 2 uterine aspirations and an endometrial biopsy at designated times. The first uterine aspiration will be randomized to one of four days (day before retrieval, day of retrieval, day after retrieval or 2 days after retrieval). The second uterine aspiration and endometrial biopsy will be performed 6 days after retrieval. Any embryo(s) obtained will be biopsied for Comprehensive Chromosome Screening (CCS) and frozen for use in a subsequent thaw cycle.

RECRUITING
Use of Artificial Intelligence for Clinical Assessment of Assisted Reproductive Techniques and IVF Outcomes
Description

The use of machine learning techniques using an artificial intelligence tool is proposed to analyze clinical data to predict best possible IVF/ART outcomes. This tool has been utilized to accurately predict embryo quality here at Cornell. Utilizing this tool to assess objective clinical findings and predict outcomes of assisted reproductive techniques is sought, with the ultimate goal of an automated tool to reduce implicit physician bias. Within this goal, using this tool to objectively and accurately assess baseline ovarian reserve at the start of an ART cycle is proposed, using 3D sonography to image the ovary and artificial intelligence tool to objectively identify baseline antral follicle counts.

TERMINATED
Impact of Parental Support on Pregnancy Outcomes (IPSO) Trial- Day 3 Preimplantation Genetic Screening (PGS) With Day 5 Fresh Transfer
Description

Natera is recruiting patients for a research study evaluating pregnancy and implantation rates in women undergoing In Vitro Fertilization (IVF) and Preimplantation Genetic Screening (PGS). PGS is also referred to as Preimplantation Genetic Diagnosis (PGD) for aneuploidy. Healthy women undergoing IVF who are between the ages of 35 to 42 years are being recruited to participate in a randomized study. The purpose of this study is to determine whether PGS- testing of embryos created during IVF for chromosomal abnormalities, prior to transfer to the uterus- improves pregnancy and implantation rates in patients when compared to patients whose embryos are not tested. PGS will be conducted using 24 Chromosome Aneuploidy Screening with Parental Support from Natera. All subjects who qualify and enroll will receive discounted IVF medications (both TEST and CONTROL arms). If you become pregnant during the study, you will receive a small payment for providing information about your pregnancy and birth. If you are assigned to the TEST arm of the study you will receive free PGS.

UNKNOWN
Impact of Physician Contact on Patient Anxiety During the Waiting Period After Embryo Transfer
Description

This will be a randomized controlled trial to compare if physician contact within the period from embryo transfer to serum pregnancy test decreases anxiety levels for first-time IVF patients.

Conditions
COMPLETED
Predicting Endometrial Receptivity for Optimal Reproductive Management
Description

The purpose of this study is to understand why some women are infertile (unable to conceive a child). The investigators hope to learn if an endometrial biopsy after egg retrieval is feasible for detecting biomarkers for endometriosis and predicting implantation and pregnancy rate after embryo transfer. This study design will provide for the first time, an opportunity to compare endometrial biopsy material from hyperstimulated (gonadotropin treated) subjects after egg retrieval. If successful, it would provide a new protocol for women with unexplained infertility or those with known endometriosis to avoid poor IVF outcomes.

COMPLETED
Salivary Diagnostic Testing for IVF
Description

This study aims to determine the performance of a salivary hormone competitive immunoassay for monitoring patients during treatment for infertility.

Conditions
COMPLETED
Frozen Embryo Donation Study
Description

The purpose of this study is to improve patient understanding of and interest in donating frozen embryos resulting from in vitro fertilization (IVF) to others undergoing infertility treatment.

Conditions
TERMINATED
In Vitro Maturation (IVM) of Human Oocytes
Description

The objectives of this study are to evaluate the clinical efficacy of Natural in vitro Fertilization and in vitro maturation.

Conditions
COMPLETED
Single Embryo Transfer of a Euploid Embryo Versus Double Embryo Transfer
Description

This study seeks to compare the pregnancy and delivery rates of patients who undergo a single embryo transfer, when the embryo has been tested and determined to be chromosomally normal, with pregnancy and delivery rates of patients who undergo a two (2) embryo transfer of untested embryos.

Conditions
COMPLETED
Effect of Colony Stimulating Factor on Implantation and Pregnancy Rates Following IVF (in Vitro Fertilization)
Description

This a trial designed to test whether granulocyte colony stimulating factor (G-CSF, Neupogen) can increase the rate of embryo implantation following IVF and embryo transfer. Preliminary data at the Center for Human Reproduction(CHR) and elsewhere suggest that intrauterine infusion of G-CSF can improve endometrial development and can increase implantation rates of embryos.

COMPLETED
RCT of Fixed vs Titrated Letrozole in Breast Cancer Patient Undergoing IVF
Description

The purpose of this study is to compare two different ways to administer Letrozole to determine their effectiveness in blocking estrogen production during ovarian stimulation in patients with breast cancer prior to chemotherapy/radiotherapy so that oocytes or embryos can be cryopreserved and patients can possibly achieve a pregnancy after the treatment of breast cancer. During standard ovulation stimulation, the estrogen levels will exceed normal levels and may reach 10 times the normal level for a 2 week period. This may not be desirable in breast cancer patients. The study hopes to determine if the investigators can stimulate oocyte development in the conventional way and administer different doses of Letrozole as the oocytes develop, to keep estradiol levels low, increase the number of oocytes the investigators are able to recover, and improve the quality of those oocytes.