Recruiting

In Vitro Maturation

Sponsor:

National Foundation for Fertility Research

Code:

NCT02516462

Conditions

Infertility

Reproductive Techniques, Assisted

Eligibility Criteria

Sex: Female

Age: 21 - 35

Healthy Volunteers: Not accepted

Interventions

IVM media

Follicle Stimulating Hormone (FSH)

Study Details

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).

Conditions

Infertility

Reproductive Techniques, Assisted

Study ID

NCT02516462

Start date

Jul, 2015

Status verified date

May, 2020

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 35

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IVM

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

Interventions

IVM media

Media to support the nuclear maturation and cytoplasmic competence of human oocytes in culture.

Follicle Stimulating Hormone (FSH)

Low dose FSH is administered to stimulate follicle growth.

Primary outcome measure

  • Pregnancy [ Time Frame: 6 months after egg retrieval ]

Central Contacts and Locations

Central contacts

Rachel Makloski, RN

303-788-8300IVMstudy@colocrm.com

Rebecca L Krisher, PhD

303-788-4868IVMstudy@colocrm.com

Locations

Fertility Laboratories of Colorado

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

Lindsey Munkwitz, RN

303-788-8300IVMstudy@colocrm.com

Rebecca L Krisher, PhD

303-788-8300IVMstudy@colocrm.com

National Foundation for Fertility Research

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

Rebecca L Krisher, PhD

303-788-8300IVMstudy@colocrm.com

More Information

Sponsor

National Foundation for Fertility Research

Last update posted

May 15, 2020

Last verified

May, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Foundation for Fertility Research on 2020-05-15.