In Vitro Maturation of Human Eggs (IVM)

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).

Study Overview

• Status: Unknown
• Conditions: Infertility; Reproductive Techniques, Assisted
• Intervention / Treatment: Device: IVM media; Drug: Follicle Stimulating Hormone (FSH)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Makloski, RN; Phone Number: 303-788-8300; Email: IVMstudy@colocrm.com
• Study Contact Backup: Name: Rebecca L Krisher, PhD; Phone Number: 303-788-4868; Email: IVMstudy@colocrm.com

Study Locations

• United States
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Recruiting
      • Fertility Laboratories of Colorado
      • Contact: Lindsey Munkwitz, RN; Phone Number: 303-788-8300; Email: IVMstudy@colocrm.com
      • Contact: Rebecca L Krisher, PhD; Phone Number: 303-788-8300; Email: IVMstudy@colocrm.com
    • Lone Tree, Colorado, United States, 80124
      • Recruiting
      • National Foundation for Fertility Research
      • Contact: Rebecca L Krisher, PhD; Phone Number: 303-788-8300; Email: IVMstudy@colocrm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: IVM; Immature oocytes recovered from each subject will be placed into IVM media for maturation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy	The incidence of pregnancy following embryo transfer of IVM produced embryos.	6 months after egg retrieval

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Offspring Weight	The birth weight of children born following IVM	1 year after egg retrieval
Offspring Gender	The gender of children born after IVM	1 year after egg retrieval
Fertilization of eggs	The percentage of mature eggs that are successfully fertilized following IVM and IVF	2 days after egg retrieval
Euploid Embryos	The percentage of euploid embryos produced as analyzed by comprehensive chromosome screening, of total embryos tested	1 month after egg retrieval

Collaborators and Investigators

• Sponsor: National Foundation for Fertility Research
• Collaborators: Fertility Laboratories Of Colorado
• Investigators: Study Director: Rebecca L Krisher, PhD, CCRM

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ANTICIPATED): December 1, 2021
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: July 30, 2015
• First Submitted That Met QC Criteria: August 3, 2015
• First Posted (ESTIMATE): August 6, 2015

Study Record Updates

• Last Update Posted (ACTUAL): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 13, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Follicle Stimulating Hormone; Hormones
• Other Study ID Numbers: NFFR-IVM-2015