In Vitro Maturation of Human Eggs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

In Vitro Maturation (IVM) of Human Oocytes

NCT01843569

Polycystic Ovarian Syndrome (PCOS) Patients Sensitive to Exogenous Gonadotropins Ovarian Hyper Stimulation Syndrome (OHSS)

WITHDRAWN NA

In Vitro Maturation (IVM) of Human Oocytes

NCT01550861

Infertility

TERMINATED NA

In Vitro Follicle Activation

NCT02496598

Primary Ovarian Insufficiency Infertility

TERMINATED NA

Effect of the Number of Inseminated Spermatozoa on Subsequent Human Embryonic Development in Vitro

NCT00710476

Spermatozoa and Embryos

COMPLETED NA

In Vitro Maturation of Human Eggs

NCT06633120

Healthy PCOS PCOS (Polycystic Ovary Syndrome) +9 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility Reproductive Techniques, Assisted

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IVM

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

Group Type EXPERIMENTAL

IVM media

Intervention Type DEVICE

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

Follicle Stimulating Hormone (FSH)

Intervention Type DRUG

Low dose FSH is administered to stimulate follicle growth.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IVM media

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

Intervention Type DEVICE

Follicle Stimulating Hormone (FSH)

Low dose FSH is administered to stimulate follicle growth.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No