In Vitro Maturation of Human Eggs (IVM)
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|ClinicalTrials.gov Identifier: NCT02516462|
Recruitment Status : Recruiting
First Posted : August 6, 2015
Last Update Posted : August 28, 2018
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).
|Condition or disease||Intervention/treatment||Phase|
|Infertility Reproductive Techniques, Assisted||Device: IVM media Drug: Follicle Stimulating Hormone (FSH)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||In Vitro Maturation of Human Eggs|
|Study Start Date :||July 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
Immature oocytes recovered from each subject will be placed into IVM media for maturation.
Device: IVM media
Media to support the nuclear maturation and cytoplasmic competence of human oocytes in culture.
Drug: Follicle Stimulating Hormone (FSH)
Low dose FSH is administered to stimulate follicle growth.
- Pregnancy [ Time Frame: 6 months after egg retrieval ]The incidence of pregnancy following embryo transfer of IVM produced embryos.
- Development of good quality blastocysts using the Gardner morphological blastocyst grading system [ Time Frame: 7 days after egg retrieval ]The proportion of good quality blastocyst stage embryos developed from IVM eggs during in vitro fertilization (IVF), of the total number of oocytes recovered
- Offspring Weight [ Time Frame: 1 year after egg retrieval ]The birth weight of children born following IVM
- Offspring Gender [ Time Frame: 1 year after egg retrieval ]The gender of children born after IVM
- Fertilization of eggs [ Time Frame: 2 days after egg retrieval ]The percentage of mature eggs that are successfully fertilized following IVM and IVF
- Euploid Embryos [ Time Frame: 1 month after egg retrieval ]The percentage of euploid embryos produced as analyzed by comprehensive chromosome screening, of total embryos tested
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516462
|Contact: Lindsey Munkwitz, RN||303-788-8300||IVMstudy@colocrm.com|
|Contact: Rebecca L Krisher, PhDfirstname.lastname@example.org|
|United States, Colorado|
|Fertility Laboratories of Colorado||Recruiting|
|Lone Tree, Colorado, United States, 80124|
|Contact: Lindsey Munkwitz, RN 303-788-8300 IVAstudy@colocrm.com|
|Contact: Rebecca L Krisher, PhD 303-781-4868 email@example.com|
|National Foundation for Fertility Research||Recruiting|
|Lone Tree, Colorado, United States, 80124|
|Contact: Rebecca L Krisher, PhD 303-781-2797 firstname.lastname@example.org|
|Study Director:||Rebecca L Krisher, PhD||NFFR|