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In Vitro Maturation of Human Eggs (IVM)

Primary Purpose

Infertility, Reproductive Techniques, Assisted

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IVM media
Follicle Stimulating Hormone (FSH)
Sponsored by
National Foundation for Fertility Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

21 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Fertility Laboratories of ColoradoRecruiting
  • National Foundation for Fertility ResearchRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IVM

Arm Description

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

Outcomes

Primary Outcome Measures

Pregnancy
The incidence of pregnancy following embryo transfer of IVM produced embryos.

Secondary Outcome Measures

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
Offspring Weight
The birth weight of children born following IVM
Offspring Gender
The gender of children born after IVM
Fertilization of eggs
The percentage of mature eggs that are successfully fertilized following IVM and IVF
Euploid Embryos
The percentage of euploid embryos produced as analyzed by comprehensive chromosome screening, of total embryos tested

Full Information

First Posted
July 30, 2015
Last Updated
May 13, 2020
Sponsor
National Foundation for Fertility Research
Collaborators
Fertility Laboratories Of Colorado
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1. Study Identification

Unique Protocol Identification Number
NCT02516462
Brief Title
In Vitro Maturation of Human Eggs
Acronym
IVM
Official Title
In Vitro Maturation of Human Eggs
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Foundation for Fertility Research
Collaborators
Fertility Laboratories Of Colorado

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Reproductive Techniques, Assisted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IVM
Arm Type
Experimental
Arm Description
Immature oocytes recovered from each subject will be placed into IVM media for maturation.
Intervention Type
Device
Intervention Name(s)
IVM media
Intervention Description
Media to support the nuclear maturation and cytoplasmic competence of human oocytes in culture.
Intervention Type
Drug
Intervention Name(s)
Follicle Stimulating Hormone (FSH)
Intervention Description
Low dose FSH is administered to stimulate follicle growth.
Primary Outcome Measure Information:
Title
Pregnancy
Description
The incidence of pregnancy following embryo transfer of IVM produced embryos.
Time Frame
6 months after egg retrieval
Secondary Outcome Measure Information:
Title
Development of good quality blastocysts using the Gardner morphological blastocyst grading system
Description
The proportion of good quality blastocyst stage embryos developed from IVM eggs during in vitro fertilization (IVF), of the total number of oocytes recovered
Time Frame
7 days after egg retrieval
Title
Offspring Weight
Description
The birth weight of children born following IVM
Time Frame
1 year after egg retrieval
Title
Offspring Gender
Description
The gender of children born after IVM
Time Frame
1 year after egg retrieval
Title
Fertilization of eggs
Description
The percentage of mature eggs that are successfully fertilized following IVM and IVF
Time Frame
2 days after egg retrieval
Title
Euploid Embryos
Description
The percentage of euploid embryos produced as analyzed by comprehensive chromosome screening, of total embryos tested
Time Frame
1 month after egg retrieval

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel Makloski, RN
Phone
303-788-8300
Email
IVMstudy@colocrm.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca L Krisher, PhD
Phone
303-788-4868
Email
IVMstudy@colocrm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca L Krisher, PhD
Organizational Affiliation
CCRM
Official's Role
Study Director
Facility Information:
Facility Name
Fertility Laboratories of Colorado
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lindsey Munkwitz, RN
Phone
303-788-8300
Email
IVMstudy@colocrm.com
First Name & Middle Initial & Last Name & Degree
Rebecca L Krisher, PhD
Phone
303-788-8300
Email
IVMstudy@colocrm.com
Facility Name
National Foundation for Fertility Research
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca L Krisher, PhD
Phone
303-788-8300
Email
IVMstudy@colocrm.com

12. IPD Sharing Statement

Learn more about this trial

In Vitro Maturation of Human Eggs

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