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Infertility clinical trials

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NCT ID: NCT02947217 Enrolling by invitation - Infertility Clinical Trials

Effect of Influenza Vaccination on IVF Outcomes - IVF

IVF-FluVac
Start date: January 19, 2017
Phase: Phase 4
Study type: Interventional

In this study the investigators propose a randomized controlled trial to evaluate the effect of influenza vaccination on clinical pregnancy rates among women undergoing in vitro fertilization.

NCT ID: NCT02946177 Enrolling by invitation - Infertility Clinical Trials

Effect of Influenza Vaccination on Donor Egg Recipient Outcomes

DE-FluVac
Start date: January 19, 2017
Phase: Phase 4
Study type: Interventional

In this study the investigators propose a randomized controlled trial to evaluate the effect of influenza vaccination on clinical pregnancy rates among women undergoing in vitro fertilization as donor egg recipients.

NCT ID: NCT02710175 Enrolling by invitation - Infertility Clinical Trials

TSH And AMH in Infertile Women

Start date: December 2015
Phase: N/A
Study type: Observational

Infertility is defined as the inability of a couple to achieve pregnancy over an average period of one year (in women under 35 years of age) or 6 months (in women above 35 years of age) of unprotected sexual intercourse. Infertility can be due to female, male reasons or both. It can be either primary or secondary. Thyroid dysfunction and autoimmune thyroiditis are known adverse risk factors for pregnancy as well as fertility, regardless of the presence of disease in women of reproductive age. In particular, hypothyroid women are at an increased risk of menstrual disorders and infertility because of altered peripheral estrogen metabolism, hyperprolactinaemia and abnormal release of gonadotropin-releasing hormone. The prevalence of subclinical hypothyroidism characterized by aberrant high serum thyroid-stimulating hormone (TSH) levels with normal free thyroxin (FT4) levels in infertile women are reported to be approximately 20% and it is a primary cause of subfertility. Indeed, average TSH levels in infertile women were reportedly higher than those in normal fertile women. And elevated serum TSH levels were associated with diminished ovarian reserve in infertile patients. Moreover, although levothyroxine replacement therapy for subclinical hypothyroidism in infertile patients remains debatable, thyroxin supplementation may improve fertility to successful pregnancy. This data suggests that hypothyroidism is strongly correlated with infertility (Velkeniers et al., 2013). On the other hand, female fecundity decreases with increasing age, primarily because of decreased ovarian function. Anti-mullerian hormone (AMH) is a dimeric glycoprotein belonging to the transforming growth factor-beta (TGF-B) super family, which act on tissue growth and differentiation. It is produced by the granulosa cells from pre-antral and small antral follicles. Ovarian research after oophorectomy showed that serum AMH levels were closely correlated with the number of primordial follicles; therefore, AMH is a suitable biomarker of ovarian age in women of reproductive age. Expectedly, ovarian function may be affected by impaired thyroid function, although this association has not been elucidated. In this study, we will evaluate the relationship between thyroid function and AMH levels by comparing them in infertile patients and healthy fertile women.

NCT ID: NCT02676479 Enrolling by invitation - Clinical trials for Genetic Diseases, Inborn

Uterine Irrigation Method in Infertility Patients Who Require PGD

Start date: February 2016
Phase: N/A
Study type: Interventional

The study will involve up to 30 pairs of male and female sexually intimate partners who are carriers for a genetic disease (e.g Sickle Cell Disease or Thalassemia) and at high risk of transmitting the gene. The female partner will be superovulated to mature multiple oocytes which can be fertilized, inseminated with her partner's sperm through intra-uterine insemination (IUI). Four to six days after IUI, the female partner will undergo a non-surgical uterine lavage procedure to recover preimplantation embryos.

NCT ID: NCT02573415 Enrolling by invitation - Clinical trials for Primary Uterine Infertility

Uterine Transplantation for the Treatment of Uterine Factor Infertility

Start date: October 2015
Phase: N/A
Study type: Interventional

This feasibility study aims to enroll ten subjects who will undergo deceased donor uterine transplantation at Cleveland Clinic. We estimate that fifty to one hundred patients with uterine factor infertility will need to be screened to identify 10 appropriate subjects. There are seven phases involved in this study: Primary and Secondary Screening, Medical Evaluation, IVF, Transplantation, Embryo Transfer, Pregnancy/Delivery and Follow up

NCT ID: NCT02179255 Enrolling by invitation - Clinical trials for Female Infertility Due to Diminished Ovarian Reserve

Human Growth Hormone Pre-treatment for 6 Weeks Prior to Ovulation Induction for IVF

Start date: August 1, 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Synthetic human growth hormone (HGH) has been available for more than a decade for specific indication in children and adults. Past Randomized Control Trials (RCT)s of HGH (under off-label use) for improving ovarian function have shown that a combination of traditional gonadotropin ovulation induction protocols, with addition of HGH is effective in increasing pregnancy rates, but not increasing egg production after IVF in women with documented diminished ovarian reserve (DOR). The investigators hypothesize that by initiating HGH at least 6 weeks prior to IVF start, the investigators will be able to increase production of oocytes and further improve pregnancy chances. This hypothesis is based on prior observations of effects of growth hormone on small antral follicles and the fact that prior studies utilized HGH principally only during ovulation induction itself. The investigators plan to recruit 30 women (15 in each group) to an open label randomized controlled trial of HGH for augmentation of ovarian response among women with documented DOR and poor prior response to ovulation induction. Eligible participants will be women < 45 years with documented history of prior retrieval of 2 or fewer oocytes while on maximal ovulation induction despite prior supplementation with dehydroepiandrosterone (DHEA). Women will be treated with 1.9 mg (5.7 units) of HGH per day, beginning about 6 weeks before start of their treatment cycle. Cost of treatment with HGH will be a cost to the participating patient. HGH will cost the patient approximately $800 per week of treatment. Patients who are randomized to the non-HGH treated group, and do not conceive, will in the following cycle be offered HGH supplementation outside of this clinical trial. This subsequent cycle will not be part of the study dataset and patients will also be responsible for the cost of HGH. Even with only 7 patients in each group, this trial will have a 99% power (error 0.05%) to detect a mean increase to 4 oocytes in the treated group. The investigators plan to recruit 15 patients in each group to allow for possible dropouts.

NCT ID: NCT02036411 Enrolling by invitation - Infertility Clinical Trials

Does Clomiphene Citrate Used for Induction of Ovulation Effect Levels of AMH and Inhibin B

Start date: September 2013
Phase: N/A
Study type: Observational

100mg clomiphene citrate used for ovulation induction. The investigators take blood sample at 3 and 10 days of menstruation and count AMH and inhibin B.

NCT ID: NCT01944241 Enrolling by invitation - Infertility Clinical Trials

Cervical Surgery and the Fertility Effect (c-SAFE)

c-SAFE
Start date: October 2012
Phase: N/A
Study type: Observational

Over the last 20 years, cervical screening programs have had huge success in reducing cervical cancer rates. These programs have done this by screening women at risk of developing cancer with regular smear tests. Women with abnormal smears are followed up in colposcopy clinics, and where needed, cervical surgery is performed to remove pre-cancerous areas on the cervix. Surgery to the cervix can include LLETZ (Large loop excision of the transformation zone) treatment or cone biopsy. Many studies in the last few years have looked at the impact that this necessary surgery can have on the function of the cervix. These studies have mainly found an association between LLETZ treatment and an increased risk of preterm labour. There have been no large studies investigating the effect cervical surgery may have on fertility. The investigators would like to examine the impact that cervical surgery may have on a woman's future fertility. It has been postulated that cervical surgery may cause the cervix to close, preventing sperm getting through or that it may cause changes in the secretions of the cervix, secretions that are necessary for normal interaction with sperm. The investigators would like to send a questionnaire to women who have attended colposcopy. The investigators will ask these women a series of questions relating to fertility desires and divide the women in to two groups depending on whether the women needed cervical surgery for pre-cancerous lesions or not. Hypothesis: That cervical surgery has an impact on the function of the cervix and on fertility.

NCT ID: NCT01689454 Enrolling by invitation - Infertility Clinical Trials

ISM1 Versus EmbrioGen Media for Embryo Culture With Previous Failure Implantation in ART Treatments

Start date: September 2012
Phase: Phase 3
Study type: Observational

Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the live birth rate in IVF patients with a previous history of pregnancy loss. Couples requiring IVF treatment and with a past experience of implantation failure will be included in the study. Controlled ovarian stimulation protocol will consist of an agonist down regulation and follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2 atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio, Måløv, Denmark) will be adopted throughout the culture period. In the control group, inseminated oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1, Origio, Måløv, Denmark), maintaining unchanged all other culture conditions. Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1 respectively. The endometrial support will be the same in the two groups.

NCT ID: NCT01689428 Enrolling by invitation - Infertility Clinical Trials

Ism1 Versus EmbryoGen Media for Embryo Culture in Previous Pregnancy Loss Cases

Start date: September 2012
Phase: Phase 3
Study type: Observational

Recently, it has been suggested that culture of embryos in EmbryoGen medium can increase the live birth rate in IVF patients with a previous history of pregnancy loss. Couples requiring IVF treatment and with a past experience of miscarriage and/or biochemical pregnancy will be included in the study. Controlled ovarian stimulation protocol will consist of an agonist down regulation and follicular stimulation by recombinant FSH. Fertilization will be achieved by standard IVF or intracytoplasmic sperm injection. Fertilized eggs will be cultured in 6% CO2, 5% O2, 89% N2 atmosphere in microdrops. In the treatment group EmbryoGen culture medium (EG, Origio, Måløv, Denmark) will be adopted throughout the culture period. In the control group, inseminated oocytes will be cultured in standard culture conditions, i.e. IMS1 medium (ISM1, Origio, Måløv, Denmark), maintaining unchanged all other culture conditions. Procedures of embryo transfer, will be carried out on day 2 using EmbryoGen or ISM1 respectively. The endometrial support will be the same in the two groups. The investigators will consider ongoing clinical pregnancy as the primary outcome assuming a 25% of increment in ongoing clinical pregnancy rate in the group with EmbryoGen medium. As secondary outcome the investigators will assume a 5% of increment in ongoing implantation rate after 12 weeks in the group with EmbryoGen medium.