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In Vitro Fertilization clinical trials

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NCT ID: NCT01287273 Recruiting - Pregnancy Clinical Trials

The Impact of Early Embryos Incubation on Pregnancy Rate in IVF

IVF-2010
Start date: April 2011
Phase: N/A
Study type: Observational

Frozen- thawed embryos obtained by IVF treatments are transferred to the uterus immediately following thawing or after incubation for additional 24-72 hours. The two methods are routine in IVF laboratories. In this study the investigators would like to compare between these two methods in terms of implantation rate, pregnancy rate and delivery.

NCT ID: NCT01220791 Recruiting - Clinical trials for In Vitro Fertilization

Methylprednisolone Addition in IVF Treatment of Infertile Couples

Start date: January 2009
Phase: Phase 4
Study type: Interventional

Hypothesis to be tested is whether follicular addition of Methylprednisolone can efficiently control late follicular progesterone rise during IVF treatment

NCT ID: NCT01210144 Terminated - Clinical trials for In Vitro Fertilization

EXpression PRofile Endometrium Samples Study

EXPRESS
Start date: August 2008
Phase: Phase 4
Study type: Interventional

This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine the gene expression profiles and histologic changes of the endometrial tissue before and after stimulation with Gonal-f®. Physicians are interested in identifying predictive genetic markers in assisted reproductive technologies (ART) in addition to the clinical predictive factors already known. Among those predictive factors, the state of the endometrium is considered as an important implantation determining factor for which pharmacogenomic research is of great interest. The direct benefits of this study will be to know whether the endometrial gene expression profile is modified in response to stimulation treatment and have an impact or not on the endometrial tissue receptivity. The potential benefits of this study could be to assess the therapy optimization based on individual treatment response and gene expression profile compared to group treatment response in infertile women and prediction of response to therapy based on gene expression profiling before and after Gonal-f® stimulation in infertile women.

NCT ID: NCT01183143 Completed - Infertility Clinical Trials

Convenience and Safety of Assisted Reproductive Technology Procedures Using a Gonal-F Filled by Mass (Fbm) Liquid Formulation Applied by Pen for Ovulation Induction and In-vitro Fertilization

Prestyje
Start date: May 11, 2004
Phase: Phase 3
Study type: Interventional

This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the convenience, safety and efficacy of the new Gonal-F fbm [recombinant follicle stimulating hormone (r-FSH)] liquid formulation, in common setting for ovulation induction (OI) and also in in-vitro fertilization (IVF).

NCT ID: NCT01065376 Completed - Clinical trials for In Vitro Fertilization

The Influence of Dopamine Agonist Cabergoline on Oocyte Maturation

Start date: January 2010
Phase: Phase 4
Study type: Interventional

The dopamine agonist cabergoline inhibits phosphorylation of the vascular endothelial growth factor receptor-2(VEGFR-2), which prevent vascular endothelial growth factor (VEGF) overexpression and reduce the severity of Ovarian hyperstimulation syndrome. However, VEGF plays an important role in the growth and maintenance of ovarian follicle and developing embryo by mediating angiogenesis.This study was designed to analyze whether the timing cabergoline administration on the day of human chorionic gonadotropin (hCG) injection or after oocytes retrieved affects the oocyte maturation and outcome of assisted reproduction treatment.

NCT ID: NCT00989053 Not yet recruiting - Depression Clinical Trials

The Effect of Selective Serotonin Reuptake Inhibitor (SSRI) Treatment on Affective Symptoms and Fertility Treatment Outcome in Women Undergoing in Vitro Fertilization (IVF)

Start date: January 2010
Phase: N/A
Study type: Interventional

Women undergoing IVF show a high prevalence of depressive and anxiety symptoms. Furthermore, stress has harmful consequences on IVF and pregnancy outcomes. An immunological cascade was suggested to be involved in the process. Treatment in this setting is usually psychotherapy rather than pharmacotherapy, despite reasonable biological evidence suggesting beneficial influence of antidepressant therapy on pregnancy and well-being. Moreover, pharmacotherapy is more available and affordable than psychotherapy in the public health system. The investigators suggest to study the efficacy of antidepressant treatment in women undergoing IVF treatment, presenting with mild mood symptoms. The investigators hypothesize that treatment will result in a greater attenuation of affective symptoms, as well as in higher pregnancy success rates. Furthermore, certain immunological stress-reactive factors, may prove to be the biological mechanism underlying these effects.

NCT ID: NCT00883766 Terminated - Clinical trials for Polycystic Ovary Syndrome

Polycystic Ovary Syndrome (PCOS) and In Vitro Fertilization (IVF): A Comparison Between Standard Long Protocol Versus an Antagonist Protocol Starting on Day 1

Start date: April 2009
Phase: N/A
Study type: Interventional

The aim of this study is to compare two different IVF-stimulation protocols in patients affected by PCOS: the use of a Gonadotropin-releasing hormone (GnRH) - antagonist starting on day 1 of controlled ovarian hyperstimulation (COH) versus a standard long agonist protocol; in order to assess whether it affects the number and quality of Metaphase II (MII) oocytes while reducing the risk of hyperstimulation. Since PCOS patients are also likely to be insulin resistant we also aim to evaluate how metformin affects tha IVF stimulation outcome.

NCT ID: NCT00866034 Terminated - Clinical trials for In Vitro Fertilization

Cetrotide Treatment Optimization

Start date: February 2009
Phase: Phase 4
Study type: Interventional

Rationale: In daily practice fertility treatment is increasingly patient focused and innovative medication and standardized treatment guidelines are being developed to improve patient convenience. GnRH antagonist cotreatment to prevent premature luteinization during ovarian stimulation for IVF and ICSI greatly reduces the burden of treatment, partly by reducing the number of injections by around 21 compared with the optimal GnRH agonist 'long' protocol. However, the optimal GnRH antagonist protocol is still not known. There are a number of reasons to suggest that both the simplicity of treatment and clinical outcomes could be further improved by commencing GnRH antagonist treatment on the same day on which ovarian stimulation is started. These include more synchronized follicle development and reduced rates of premature luteinization. This study will investigate whether a novel early fixed start protocol improves outcomes in comparison to the widely employed late fixed start protocol. Objective: To demonstrate whether an early fixed start antagonist protocol improves the live birth rate compared with a late fixed start antagonist protocol by 5%. Study design: Prospective, multicenter, investigator sponsored, randomized controlled trial Study population: - Normo-ovulatory women < 39 years with an indication for IVF or ICSI - No more than 2 previous unsuccessful IVF/ICSI cycles - BMI ≤ 32 kg/m2 Intervention: Two different GnRH antagonist treatment protocols used in daily practice will be compared. Patients will be randomized to receive one of the following two treatments: - Early fixed start: start GnRH antagonist treatment with Cetrotide 0.25 mg on the same day as FSH, cycle day 2. - Late fixed start: FSH will be administered from cycle day 2. GnRH antagonist treatment with Cetrotide 0.25 mg will commence on cycle day 6. Main study parameters/endpoints: The primary endpoint is the live birth rate per started cycle. A secondary endpoint is the number of embryos available for transfer. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: In addition to recording clinical outcomes, endocrine studies will be carried out at the UMC Utrecht in a sample of 200 participants who will be subjected to blood sampling at three points during the treatment cycle: prior to commencing treatment on cycle day 2, cycle day 6 and the day of hCG administration.The aim of this substudy was therefore to prospectively compare the effect of a cycle day 2 versus cycle day 6 fixed start GnRH antagonist protocol on LH, estradiol and progesterone levels in the mid and late follicular phase. In order to investigate whether the early fixed protocol exerts a significant extra burden on patients compared to the late start protocol, another group of 200 participants at the UMCU will be requested to complete the HADS questionnaire (Hospital Anxiety and Depression Scale).

NCT ID: NCT00866008 Terminated - Clinical trials for In Vitro Fertilization

A Study of the Effects of a Novel Ovarian Stimulation Regimen on Embryo Aneuploidy Rates in In Vitro Fertilization (IVF)

Start date: October 2008
Phase: Phase 4
Study type: Interventional

Background: By limiting the number of embryos transferred to the uterus to only a single embryo, the risk of multiple gestation can be reduced. In order to improve the effectiveness of single embryo transfer, the ability to select the embryo with the highest potential to develop into a healthy child is of vital importance. While embryos rated as high quality by standardized morphological assessment are associated with higher implantation and pregnancy rates, it is still not possible to predict with certainty which embryo will implant and has the highest potential to develop into a healthy child. An increasing body of evidence indicates that the incidence of chromosomal abnormalities in embryos is extremely high and good embryo morphology does not necessarily exclude an abnormal chromosomal constitution. Since aneuploidies are considered the main cause of embryonic wastage and loss, this phenomenon may be primarily responsible for the relatively poor pregnancy rates reported after IVF. The introduction of fluorescent in-situ hybridization (FISH) techniques for preimplantation genetic diagnosis has enabled screening of embryos for chromosomal aneuploidies before transfer. Preimplantation genetic screening (PGS) would be of special interest for couples that are thought to have a higher risk of developing chromosomally abnormal embryos, with the aim of improving their chances for an ongoing pregnancy after IVF. PGS is applied clinically in numerous IVF laboratories throughout the world, and high rates of chromosomal abnormalities have been reported in IVF derived embryos. However, a recent meta-analysis has shown that PGS is yet to have a significant impact on IVF outcomes. This may partly be explained by the fact that most aneuploidies observed at this stage originate during the first mitotic divisions of early preimplantation development, resulting in chromosomally mosaic embryos. If a chromosomally mosaic embryo is biopsied, this cell may not be representative for the remaining embryo. The investigators' group recently completed the first prospectively designed, randomized trial, comparing embryo aneuploidy rates following two ovarian hyperstimulation regimes in a group of 111 IVF patients. Milder stimulation was associated with a reduction in the number of oocytes retrieved and embryos generated. However, the proportion of chromosomally normal embryos was significantly increased. These results showed for the first time a direct correlation between the ovarian stimulation protocol and the incidence of chromosome abnormalities in the embryo. The observation that mild stimulation in some patients still resulted in a high oocyte yield and concurring higher proportions of abnormal embryos, underscores the need for further development of minimal stimulation approaches. Primary Objective: To determine whether the administration of hCG during the late follicular phase, instead of continuing with a fixed dose FSH, results in a more homogeneous cohort of growing follicles and the development of only the most competent oocytes, leading to lower aneuploidy rates in resulting embryos. Study design: Prospectively randomized, clinical study in 110 women undergoing IVF treatment Intervention: Randomization to one of two ovarian stimulation protocols: 1. Conventional regimen with a daily dose of 225 IU recombinant FSH and GnRH agonist long protocol co-treatment 2. Mild ovarian stimulation regimen using the endogenous FSH production by starting treatment on day 5 of the menstrual cycle with 150 IU / d recFSH with GnRH antagonist co treatment starting on day 6. As soon as two follicles reach 12 mm, treatment is continued with 200 IU / d rec hCG. In both arms, oocyte pick up, insemination and embryo culture will be performed according to standard procedures. On day 3, all suitable embryos will be biopsied and one or two blastomeres removed, depending on the number of cells within the embryo. FISH analysis will be performed for 10 chromosomes (1, 7, 13, 15, 16, 18, 21, 22, X and Y). Only chromosomally normal embryos will be transferred and cryopreserved. Embryos diagnosed as aneuploid or mosaic will be investigated for their implantation and developmental potential, by transferring them to an in vitro implantation model. After an extended culture period, implantation behaviour will be assessed and the entire embryo is reanalysed to detect the proportion of chromosomally abnormal cells. The implantation behaviour will be correlated to the type of abnormality and the chromosome(s) involved. Primary outcome parameters: Ovarian response, as assessed by the number of oocytes obtained and the proportion of chromosomally abnormal embryos per patient. Secondary outcome parameters: Number of oocytes retrieved, fertilization rates and proportion of morphologically high quality embryos on day 3. Serum estradiol, LH, progesterone, androgen and hCG levels on cycle day 3 and day of hCG.

NCT ID: NCT00828191 Completed - Clinical trials for In Vitro Fertilization

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

Start date: December 2008
Phase: Phase 3
Study type: Interventional

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.