Comparison of Alternative Embryo Culture Systems

NCT ID: NCT02028897

Last Updated: 2015-01-08

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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This study will compare two alternative embryo culture systems. Embryos from each patient will be randomly assigned to one of two systems. One group will be cultured conventionally in oil-covered droplets in dishes. The other group will be assigned to an enclosed system.

Detailed Description

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Qualifying and consenting IVF patients will have approximately half of their developing embryos cultured in droplets covered with oil. The other approximate half of their embryos will be cultured in small enclosed containers. Embryo assignments will be at random. Regardless of culture system, all embryos will be cultured from the bipronuclear stage to the blastocyst stage in the same (Global) media, without the usual refreshing of media on day 3.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional embryo culture

Conventional embryo culture in dishes, in droplets under oil.

Group Type ACTIVE_COMPARATOR

Conventional embryo culture

Intervention Type OTHER

Alternative embryo culture

Embryo culture in system using small enclosed containers

Group Type EXPERIMENTAL

Enclosed embryo culture

Intervention Type OTHER

Interventions

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Conventional embryo culture

Intervention Type OTHER

Enclosed embryo culture

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female age 18 to 40, seeking IVF treatment
* Ability to understand English (to obtain informed consent)
* Use of an oocyte donor, sperm donor, gestational carrier, and/or genetic testing (with blastocyst biopsy only) are allowed.

Exclusion Criteria

* Diminished ovarian reserve as evidenced by either elevated cycle day 3 follicle stimulating hormone (FSH) level (≥10 IU/L) or low antral follicle count (\<8 antral follicles)
* Fewer than five (5) bipronuclear oocytes
* Day 3 embryo biopsy for any reason
* No minors may enroll
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bruce Shapiro M.D.

INDUSTRY

Sponsor Role lead

Responsible Party

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Bruce Shapiro M.D.

Medical Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bruce Shapiro, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fertility Center of Las Vegas

Locations

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Fertility Center of Las Vegas

Las Vegas, Nevada, United States

Site Status

Countries

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United States

Other Identifiers

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SAIRB-13-0040

Identifier Type: -

Identifier Source: org_study_id

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