In Vitro Maturation of Human Eggs

Infertility Clinical Trial

— IVM  

Official title:

In Vitro Maturation of Human Eggs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02516462
• Other study ID #: NFFR-IVM-2015
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Infertility
• Reproductive Techniques, Assisted

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