In Vitro Maturation of Human Eggs

Study Overview
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Brief Summary
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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).

Detailed Description
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The novel device (IVM media system), is designed to support nuclear maturation of immature oocytes recovered after minimal ovarian stimulation with no LH/hCG administration, and improve oocyte competence. This may result in development of a greater number of embryos to the blastocyst stage. FSH is administered starting on cycle day 3 to stimulate follicle growth. When the leading follicle reaches 12-14 mm, egg retrieval will be scheduled. No hCG/LH trigger will be administered. Specially designed maturation media is used to collect and culture the immature eggs once recovered from the follicle. Once the eggs have matured in vitro, fertilization and embryo culture, vitrification and comprehensive chromosomal screening will be completed as per standard operating procedures.

Official Title
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In Vitro Maturation of Human Eggs

Conditions
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Infertility, Reproductive Techniques, Assisted

Intervention / Treatment
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* Device: IVM media
* Drug: Follicle Stimulating Hormone (FSH)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVM<br>Immature oocytes recovered from each subject will be placed into IVM media for maturation. | Device: IVM media<br>* Media to support the nuclear maturation and cytoplasmic competence of human oocytes in culture.<br>Drug: Follicle Stimulating Hormone (FSH)<br>* Low dose FSH is administered to stimulate follicle growth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy | The incidence of pregnancy following embryo transfer of IVM produced embryos. | 6 months after egg retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Offspring Weight | The birth weight of children born following IVM | 1 year after egg retrieval | 
| Offspring Gender | The gender of children born after IVM | 1 year after egg retrieval | 
| Fertilization of eggs | The percentage of mature eggs that are successfully fertilized following IVM and IVF | 2 days after egg retrieval | 
| Euploid Embryos | The percentage of euploid embryos produced as analyzed by comprehensive chromosome screening, of total embryos tested | 1 month after egg retrieval |