NCT02516462

In Vitro Maturation of Human Eggs

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: National Foundation for Fertility Research · Academic / Other
• Sex: Female
• Age: 21 Years – 35 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Infertility
• Reproductive Techniques, Assisted

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-07-01
• Primary completion: 2021-12-01
• Completion: 2022-12-01
• First posted: 2015-08-06
• Last updated: 2020-05-15

Locations

2 sites across 1 country: United States