Trial | NCT02516462  Report issue

Official Title

In Vitro Maturation of Human Eggs

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    follitropin alfa ...

  • Study Participants

    100
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.
Study Started
Jul 31
2015
Primary Completion
Dec 31
2021
Anticipated
Study Completion
Dec 31
2022
Anticipated
Last Update
May 15
2020

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.

IVM Experimental

Immature oocytes recovered from each subject will be placed into IVM media for maturation.

Criteria 

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.
No Results Posted