Clinical trial NCT02516462: In Vitro Maturation of Human Eggs
Official title: In Vitro Maturation of Human Eggs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Reproductive Techniques, Assisted
Lead sponsor: National Foundation for Fertility Research
Sponsor class: OTHER
Collaborators: name: Fertility Laboratories Of Colorado
First posted: 2015-08-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: Pregnancy
timeFrame: 6 months after egg retrieval
Secondary outcomes:
measure: Development of good quality blastocysts using the Gardner morphological blastocyst grading system
timeFrame: 7 days after egg retrieval
measure: Offspring Weight
timeFrame: 1 year after egg retrieval
measure: Offspring Gender
timeFrame: 1 year after egg retrieval
measure: Fertilization of eggs
timeFrame: 2 days after egg retrieval
measure: Euploid Embryos
timeFrame: 1 month after egg retrieval
Other outcomes:
Locations:
city: Lone Tree
country: United States
facility: Fertility Laboratories of Colorado
state: Colorado
city: Lone Tree
country: United States
facility: National Foundation for Fertility Research
state: Colorado
Study officials:
affiliation: CCRM
name: Rebecca L Krisher, PhD
role: STUDY_DIRECTOR
References: