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In Vitro Maturation of Human Eggs (IVM)

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ClinicalTrials.gov Identifier: NCT02516462
Recruitment Status : Recruiting
First Posted : August 6, 2015
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
Fertility Laboratories Of Colorado
Information provided by (Responsible Party):
National Foundation for Fertility Research

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).


Condition or disease Intervention/treatment Phase
Infertility Reproductive Techniques, Assisted Device: IVM media Drug: Follicle Stimulating Hormone (FSH) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: In Vitro Maturation of Human Eggs
Study Start Date : July 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

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.




Primary Outcome Measures :
  1. Pregnancy [ Time Frame: 6 months after egg retrieval ]
    The incidence of pregnancy following embryo transfer of IVM produced embryos.


Secondary Outcome Measures :
  1. Development of good quality blastocysts using the Gardner morphological blastocyst grading system [ Time Frame: 7 days after egg retrieval ]
    The proportion of good quality blastocyst stage embryos developed from IVM eggs during in vitro fertilization (IVF), of the total number of oocytes recovered

  2. Offspring Weight [ Time Frame: 1 year after egg retrieval ]
    The birth weight of children born following IVM

  3. Offspring Gender [ Time Frame: 1 year after egg retrieval ]
    The gender of children born after IVM

  4. Fertilization of eggs [ Time Frame: 2 days after egg retrieval ]
    The percentage of mature eggs that are successfully fertilized following IVM and IVF

  5. Euploid Embryos [ Time Frame: 1 month after egg retrieval ]
    The percentage of euploid embryos produced as analyzed by comprehensive chromosome screening, of total embryos tested



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Ages Eligible for Study:   35 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infertile women of advanced maternal age (>35 years) who desire to conceive and come to CCRM for infertility treatment using IVF will be candidates for this study.
  • Patients can be of any race, culture, sexual orientation or ethnicity.

Exclusion Criteria:

  • Minors are excluded from participation in this study.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516462


Contacts
Contact: Lindsey Munkwitz, RN 303-788-8300 IVMstudy@colocrm.com
Contact: Rebecca L Krisher, PhD 303-788-4868 rkrisher@fertilityresearch.org

Locations
United States, Colorado
Fertility Laboratories of Colorado Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Lindsey Munkwitz, RN    303-788-8300    IVAstudy@colocrm.com   
Contact: Rebecca L Krisher, PhD    303-781-4868    rkrisher@fertilityresearch.org   
National Foundation for Fertility Research Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Rebecca L Krisher, PhD    303-781-2797    rkrisher@fertilityresearch.org   
Sponsors and Collaborators
National Foundation for Fertility Research
Fertility Laboratories Of Colorado
Investigators
Study Director: Rebecca L Krisher, PhD NFFR

Responsible Party: National Foundation for Fertility Research
ClinicalTrials.gov Identifier: NCT02516462     History of Changes
Other Study ID Numbers: NFFR-IVM-2015
First Posted: August 6, 2015    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
Follicle Stimulating Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs