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Comparison of Culture Media for in Vitro Embryo Development

NCT ID: NCT02846012

Last Updated: 2017-12-27

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-12-22

Brief Summary

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The purpose of this study is to collect development and outcome data on human embryos which are cultured in a 2nd generation continuous single culture medium (CSCM2) with the objective to demonstrate its performance efficacy in comparison to existing commercially available single culture or continuous embryo culture media.

Detailed Description

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A multi-center (3 sites and 2 investigators), prospective trial with up to 300 patients. Patients will be enrolled from participating sites from the United States. Study sites will conduct this study under the oversight of Sterling IRB. Each study site should enroll enough patients to achieve at least 50 evaluable patients that have undergone a treatment cycle using split case sibling embryos in which half of the embryos are cultured in CSCM2 and the other half in current CSCM (as control).

The methods will consist of standard ovarian stimulation protocols at each facility to obtain a sufficient number of mature (MII) oocytes for fertilization by ICSI. Following fertilization, identified diploid (2PN) zygotes will be evenly divided and randomly allocated to the embryo culture treatment conditions of CSCM2 or CSCM and cultured according to standard laboratory procedure (incubated in 5-6% CO2 in air or low O2 concentrations of 5-6%) to the blastocyst stage (Day 5/6 or 7). Top quality blastocyst(s) will be transferred and monitored for implantation, pregnancy and ongoing birth. Embryo transfers will either occur in a fresh or frozen cycle.

The procedures in this study are designed to follow the standard medical care at each study site for women having IVF treatment (the participant will sign a separate consent at your clinic for your IVF procedures). The participants study doctor will explain in detail the procedures participants will undergo at the clinic; this form is only meant to explain the details of the research study. This study does not involve randomization of patient participation or any sham procedures.

Conditions

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Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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CSCM Control

Control medium

Group Type NO_INTERVENTION

No interventions assigned to this group

CSCM2

New Formulation medium

Group Type EXPERIMENTAL

CSCM2

Intervention Type OTHER

Interventions

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CSCM2

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* At least 18 years of age in good general physical and mental health.
* Women undergoing fresh in vitro fertilization treatment using their own eggs which will be fertilized by ICSI only
* Normal uterine cavity, as defined by the program.
* Normal BMI (\< 35).
* Normal endocrine workup (including PCOS patients).
* Fresh or Frozen Blastocyst transfer
* At least 4 diploid zygotes showing signs of normal (2PN) fertilisation
* Willing to have half of their 2PN embryos cultured in CSCM and the other half of their 2PN embryos cultured in CSCM 2nd generation
* Willing to comply with study protocol and procedures
* Willing to provide written informed consent

Exclusion Criteria

* Use of donor egg / gestational carrier
* Couples for whom the male partner requires surgically extracted sperm (testicular or epididymal retrieval)
* History of complications related to tolerance to OCP's, Gonadotropins, Progesterone or estrogen.
* A medical condition that is contraindicated to pregnancy or gonadotropin therapy (eg. allergies, immune deficiency, etc.)
* History of cancer
Minimum Eligible Age

18 Years

Maximum Eligible Age

51 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ovation Fertility

OTHER

Sponsor Role lead

Responsible Party

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Matthew VerMilyea

Laboratory Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matthew VerMilyea, PhD

Role: PRINCIPAL_INVESTIGATOR

Ovation Fertility

Locations

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Ovation Fertility - Austin

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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2016-NxGeM-01

Identifier Type: -

Identifier Source: org_study_id