Infertility Clinical Trial
— IVMOfficial title:
In Vitro Maturation of Human Eggs
NCT number | NCT02516462 |
Other study ID # | NFFR-IVM-2015 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | December 2022 |
Because a large proportion of the embryo's quality is dependent upon the egg, this
investigation focuses on treatment of the oocyte during in vitro maturation (IVM). In typical
IVF cycles, the egg is recovered when it is mature and ready to be fertilized. However, at
this point the oocyte's quality has been set, and cannot be altered. Therefore, to have an
impact on oocyte quality the use of in IVM is critical. Development of a successful IVM
protocol for clinical use would not only provide an option for women of advanced maternal
age, it would also reduce the cost of IVF due to fewer exogenous gonadotropins used for
stimulation, and significantly lessen the risk of ovarian hyper-stimulation.
The objective of this research study is to evaluate a newly developed oocyte maturation media
system for human clinical use in assisted reproductive technology (ART).
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2022 |
Est. primary completion date | December 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 21 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Infertile women who desire to conceive and come to CCRM for infertility treatment using IVF will be candidates for this study. - Women with PCOS - Patients can be of any race, culture, sexual orientation or ethnicity. Exclusion Criteria: - Minors are excluded from participation in this study. - Women with a BMI greater than 40 - Women whose health is such that becoming pregnant carries risk significantly greater than healthy women are excluded from this study, unless they use a gestational carrier under the direction of their physician. |
Country | Name | City | State |
---|---|---|---|
United States | Fertility Laboratories of Colorado | Lone Tree | Colorado |
United States | National Foundation for Fertility Research | Lone Tree | Colorado |
Lead Sponsor | Collaborator |
---|---|
National Foundation for Fertility Research | Fertility Laboratories Of Colorado |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pregnancy | The incidence of pregnancy following embryo transfer of IVM produced embryos. | 6 months after egg retrieval | |
Secondary | Development of good quality blastocysts using the Gardner morphological blastocyst grading system | The proportion of good quality blastocyst stage embryos developed from IVM eggs during in vitro fertilization (IVF), of the total number of oocytes recovered | 7 days after egg retrieval | |
Secondary | Offspring Weight | The birth weight of children born following IVM | 1 year after egg retrieval | |
Secondary | Offspring Gender | The gender of children born after IVM | 1 year after egg retrieval | |
Secondary | Fertilization of eggs | The percentage of mature eggs that are successfully fertilized following IVM and IVF | 2 days after egg retrieval | |
Secondary | Euploid Embryos | The percentage of euploid embryos produced as analyzed by comprehensive chromosome screening, of total embryos tested | 1 month after egg retrieval |
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