Each Patient is Both Case and ControlNCT01219504
Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing In Vitro Fertilization (IVF)
An observational study of Each Patient is Both Case and Control and 1 Embryo Will be Biopsied and 1 Embryo is Not, run by Reproductive Medicine Associates of New Jersey at 3 sites in United States.
Trial summary
To assess the impact of embryo biopsy on the reproductive potential of human embryos. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Each Patient is Both Case and Control, 1 Embryo Will be Biopsied and 1 Embryo is Not
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2008to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 200 infertile couples undergoing IVF will be enrolled in the study.
Who may be able to join
- Maximum of one prior failed IVF treatment cycle
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Reproductive Medicine Associates of New Jersey
Morristown, New Jersey, 07960
Reproductive Medicine Associates of New York
New York, New Jersey, 10022
Reproductive Medicine Associates of Connecticut
Norfolk, Connecticut, 06850
About this study
Official title: Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing IVF
To assess the impact of embryo biopsy on the reproductive potential of human embryos.
Read the detailed description
This study will recruit patients from the NY/NJ/CT/eastern PA area only.
All patients will undergo an in vitro fertilization (IVF) cycle with hormonal stimulation and an egg retrieval procedure as deemed appropriate for their diagnosis. Following biopsy, the embryos will be transferred. There will be no delay in the time of transfer as no cells will be analyzed prior to transfer.
On day 3 or day 5 of embryo development, all patients will undergo a two (2) embryo transfer. The embryos selected for transfer will be the 2 morphologically best of the embryo cohort. Once selected for transfer, the embryos will be randomized so that one will be biopsied and the other will be transferred without undergoing biopsy. The embryo randomized to biopsy will have a single cell biopsied.
Following delivery, buccal swabs will be collected from infants.
- Keywords
- PGD, IVF
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of biopsy on pregnancy
Impact of the biopsy of the embryo on whether a pregnancy is obtained
Measured: 1 year
Impact of biopsy on delivery
Impact of the biopsy on pregnancy resulting in delivery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startApr 2008
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Each Patient is Both Case and ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard T Scott, MD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219504
- Sponsor's protocol ID
- RMA-00-17
- Status last verified
- Jan 2013
- First submitted
- 8 Oct 2010
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23773313
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing IVF
- ClinicalTrials.gov ID
- NCT01219504
- Acronym / sponsor ID
- RMA-00-17
- Keywords
- PGD, IVF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the impact of embryo biopsy on the reproductive potential of human embryos.
Detailed description
This study will recruit patients from the NY/NJ/CT/eastern PA area only.
All patients will undergo an in vitro fertilization (IVF) cycle with hormonal stimulation and an egg retrieval procedure as deemed appropriate for their diagnosis. Following biopsy, the embryos will be transferred. There will be no delay in the time of transfer as no cells will be analyzed prior to transfer.
On day 3 or day 5 of embryo development, all patients will undergo a two (2) embryo transfer. The embryos selected for transfer will be the 2 morphologically best of the embryo cohort. Once selected for transfer, the embryos will be randomized so that one will be biopsied and the other will be transferred without undergoing biopsy. The embryo randomized to biopsy will have a single cell biopsied.
Following delivery, buccal swabs will be collected from infants.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 200 infertile couples undergoing IVF will be enrolled in the study.
Key inclusion criteria (7 listed)
- Maximum of one prior failed IVF treatment cycle
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Impact of biopsy on pregnancy
Time frame: 1 year
Impact of the biopsy of the embryo on whether a pregnancy is obtained
Impact of biopsy on delivery
Time frame: 1 year
Impact of the biopsy on pregnancy resulting in delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
- Derived from this study: PubMed 23773313Scott 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard T Scott, MD principal investigator
Reproductive Medicine Associates of New Jersey
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Each Patient is Both Case and Control and 1 Embryo Will be Biopsied and 1 Embryo is Not, run by Reproductive Medicine Associates of New Jersey at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of biopsy on pregnancy (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01219504, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.