NCT01219504

Completed

Evaluation of the Impact of Embryo Biopsy on the Reproductiv...

Reproductive Medicine Associates of New Jersey Source

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Other study identifiers

Sponsor study identifier

RMA-00-17

Study Type

observational

Actual enrollment (reported)

200

Locations

1 country

Sites

3

Timeline

Study Start

April 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2012

Actual (reported)

Study Completion

September 2012

Actual (reported)

Brief Summary

To assess the impact of embryo biopsy on the reproductive potential of human embryos.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 200 participants
Study completion date: September 2012
Actual (reported)
Listed locations: 1 countries · 3 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2008
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
October 8, 2010
Actual (reported)
First Posted
October 13, 2010
Actual (reported)
Primary Completion
September 2012
Actual (reported)
Study Completion
September 2012
Actual (reported)

Last Updated: January 23, 2013
Status Verified: January 2013
Last Update Submitted: January 22, 2013

Conditions

1 Embryo Will be Biopsied and 1 Embryo is Not Each Patient is Both Case and Control

Keywords

PGDIVF

Outcome Measures

Primary Outcomes (2)

Impact of biopsy on pregnancy
Impact of the biopsy of the embryo on whether a pregnancy is obtained
1 year
Impact of biopsy on delivery
Impact of the biopsy on pregnancy resulting in delivery
1 year

Eligibility Criteria

Age18 Years - 35 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodNon-Probability Sample

Study Population

200 infertile couples undergoing IVF will be enrolled in the study.

You may qualify if:

Maximum of one prior failed IVF treatment cycle

Sponsors & Collaborators

Reproductive Medicine Associates of New Jersey
Otherlead

Study Sites (3)

Reproductive Medicine Associates of Connecticut

Norfolk, Connecticut, 06850, United States

Reproductive Medicine Associates of New Jersey

Morristown, New Jersey, 07960, United States

Reproductive Medicine Associates of New York

New York, New Jersey, 10022, United States

Related Publications (1)

Scott RT Jr, Upham KM, Forman EJ, Zhao T, Treff NR. Cleavage-stage biopsy significantly impairs human embryonic implantation potential while blastocyst biopsy does not: a randomized and paired clinical trial. Fertil Steril. 2013 Sep;100(3):624-30. doi: 10.1016/j.fertnstert.2013.04.039. Epub 2013 Jun 15.
PMID: 23773313DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples on female and male patients. Buccal swabs on infant(s).

Study Officials

Richard T Scott, MD
Reproductive Medicine Associates of New Jersey
PRINCIPAL INVESTIGATOR

Enrollment

200 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 8, 2010

First Posted

October 13, 2010

Study Start

April 2008

Date type not reported

This date has not been verified as actual or estimated.

Female partner less than 35 years of age

Normal day 3 FSH level (\<10 miu/mL)

Total basal antral follicle count greater than or equal to 12

Male partner with greater than 100,000 total motile spermatozoa and at least 1% normal forms

Body mass index (BMI) \< or = 32

Normal uterine cavity

You may not qualify if:

Diagnosis of chronic anovulation secondary to polycystic ovarian disease
Diagnosis of endometrial insufficiency
Clinical indication for pre-implantation genetic diagnosis (PGD) (undergoing IVF with PGD to rule out a known genetic defect)
Use of testicular aspiration or biopsy procedures to obtain sperm

Contact the study team to confirm eligibility.

Primary Completion

September 2012

Actual (reported)

Study Completion

September 2012

Actual (reported)

Last Updated

January 23, 2013

Record last verified: 2013-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01219504
Data provider: ClinicalTrials.gov
Source updated: 2013-01-23
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:53 UTC

Locations

US(3)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (1)

Biospecimen

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations