Effect of Oocyte Vitrification on Fertilization Rate, Embryo Quality and Development

NCT ID: NCT01422395

Last Updated: 2014-06-04

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

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-05-31

Brief Summary

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Indications for oocyte (egg) vitrification (fast freezing) include the preservation of reproductive competence of young cancer patients who need chemotherapy, pelvic radiation, or surgical removal of ovaries for treatment. Furthermore, the ability to freeze oocytes allows patients to reduce the number of embryos frozen, thereby circumventing the moral and ethical dilemmas of having left-over embryos in cryostorage. In addition, oocyte cryopreservation could allow women to delay childbearing if they want or need to. Until recently, conventional cryopreservation protocols have remained too inefficient for practical application in an infertility center. Very little is known about the effects of vitrification on oocytes and subsequent embryo development, especially using the sibling model (group of oocytes from the same cohort of ovarian follicles within patient). The purpose of this study is to examine the effect of oocyte vitrification on fertilization rates, embryo quality and development.

Detailed Description

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Conditions

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Fertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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freezing

Group Type EXPERIMENTAL

Freezing

Intervention Type PROCEDURE

Vitrification

No freezing

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Freezing

Vitrification

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* healthy women ages 21-37 (inclusive)undergoing IVF in an attempt to achieve pregnancy
* Day 2-4 FSH \< 10 IU/ml, LH \<12 IU/ml, and E2 \<50 pg/ml
* Antimullerian Hormone (AMH) \>1.5
* Between 5 and 20 basal antral follicles on day 2-4 of the menstrual cycle
* BMI \>18 and \<32

Exclusion Criteria

* Smokers
* Polycystic Ovarian Syndrome (PCO)
Minimum Eligible Age

21 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Main Line Fertility Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Glassner J Michael, M.D.

Role: PRINCIPAL_INVESTIGATOR

Main Line Fertility Center

Sharon H. Anderson, Ph.D

Role: STUDY_DIRECTOR

Main Line Fertility Center

Locations

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Main Line Fertility Center

Bryn Mawr, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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MLFC-001

Identifier Type: -

Identifier Source: org_study_id

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