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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date May 2020
Source National Foundation for Fertility Research
Contact Rachel Makloski, RN
Phone 303-788-8300
Email IVMstudy@colocrm.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Fertility Laboratories of Colorado Lone Tree Colorado
United States National Foundation for Fertility Research Lone Tree Colorado

Sponsors (2)

Lead Sponsor Collaborator
National Foundation for Fertility Research Fertility Laboratories Of Colorado

Country where clinical trial is conducted

United States, 

Outcome

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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