In Vitro Maturation of Human Eggs
IVM
1 other identifier
interventional
100
1 country
2
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 30, 2015
CompletedFirst Posted
Study publicly available on registry
August 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMay 15, 2020
May 1, 2020
6.4 years
July 30, 2015
May 13, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Pregnancy
The incidence of pregnancy following embryo transfer of IVM produced embryos.
6 months after egg retrieval
Secondary Outcomes (5)
Development of good quality blastocysts using the Gardner morphological blastocyst grading system
7 days after egg retrieval
Offspring Weight
1 year after egg retrieval
Offspring Gender
1 year after egg retrieval
Fertilization of eggs
2 days after egg retrieval
Euploid Embryos
1 month after egg retrieval
Study Arms (1)
IVM
EXPERIMENTALImmature oocytes recovered from each subject will be placed into IVM media for maturation.
Interventions
Media to support the nuclear maturation and cytoplasmic competence of human oocytes in culture.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Fertility Laboratories of Colorado
Lone Tree, Colorado, 80124, United States
National Foundation for Fertility Research
Lone Tree, Colorado, 80124, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rebecca L Krisher, PhD
CCRM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2015
First Posted
August 6, 2015
Study Start
July 1, 2015
Primary Completion
December 1, 2021
Study Completion
December 1, 2022
Last Updated
May 15, 2020
Record last verified: 2020-05