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| Name | Class |
|---|---|
| Fertility Laboratories Of Colorado | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IVM | Experimental | Immature oocytes recovered from each subject will be placed into IVM media for maturation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVM media | Device | Media to support the nuclear maturation and cytoplasmic competence of human oocytes in culture. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy | The incidence of pregnancy following embryo transfer of IVM produced embryos. | 6 months after egg retrieval |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Makloski, RN | Contact | 303-788-8300 | IVMstudy@colocrm.com | |
| Rebecca L Krisher, PhD | Contact | 303-788-4868 | IVMstudy@colocrm.com |
| Name | Affiliation | Role |
|---|---|---|
| Rebecca L Krisher, PhD | CCRM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fertility Laboratories of Colorado | Recruiting | Lone Tree | Colorado | 80124 | United States |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005640 | Follicle Stimulating Hormone |
| ID | Term |
|---|---|
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Follicle Stimulating Hormone (FSH) | Drug | Low dose FSH is administered to stimulate follicle growth. |
|
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 |
| National Foundation for Fertility Research | Recruiting | Lone Tree | Colorado | 80124 | United States |
|
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |