Effect of PGD on Implantation Rates in IVF CyclesNCT01219283
Study of the Efficacy of 24 Chromosome Preimplantation Genetic Diagnosis (PGD)
An observational study of Effect of PGD on Implantation Rates in IVF Cycles, run by Reproductive Medicine Associates of New Jersey at 3 sites in United States.
Trial summary
The purpose of this study is to determine if 24 chromosome preimplantation genetic diagnosis (PGD) increases implantation and delivery rates in couples attempting to conceive through in vitro fertilization (IVF). Read more about this study
- Who is it for?
- Ages 21 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Effect of PGD on Implantation Rates in IVF Cycles
- How many people
- 334 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2009to Jun 2013
- 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 21 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 500 patients attempting conception through IVF who have a maximum of one prior failed IVF cycle.
Major Inclusion Criteria:
- Age of female partner of < 43 years
- Normal day-three FSH level (< 15 mIU/mL)
- Normal uterine cavity
- Sufficient ejaculated spermatozoa in male partner for ART
- Maximum of one prior failed IVF cycle
Major Exclusion Criteria:
- FSH level ≥ 15 mIU/mL
- BMI greater than 32 kg/m2
- Contraindication to gonadotropin stimulation
- Unevaluated Ovarian mass
- Need for surgical sperm removal
- Any contraindication to undergoing in vitro fertilization
- Age greater than 43 years
- Presence of hydrosalpinges which communicate with the endometrial cavity
- Clinical indication for PGD (undergoing IVF with PGD to rule out a known genetic defect)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Reproductive Medicine Associates of PA at Lehigh Valley
Allentown, Pennsylvania, 18104
Colorado Center for Reproductive Medicine
Lone Tree, Colorado, 18104
Reproductive Medicine Associates
Morristown, New Jersey, 07960
About this study
Official title: A Prospective Randomized Clinical Trial to Determine the Efficacy of 24 Chromosome Preimplantation Genetic Diagnosis
The purpose of this study is to determine if 24 chromosome preimplantation genetic diagnosis (PGD) increases implantation and delivery rates in couples attempting to conceive through in vitro fertilization (IVF).
Read the detailed description
FISH based PGD techniques have provided little improvement in implantation and delivery rates. We believe that the use of 24 chromosome PGD, as compared to control (no PGD) will show a benefit to patients. This study is a randomized clinical trial that seeks to validate 24 chromosome PGD.
Patients that meet the eligibility criteria will be randomized prior to embryo transfer. In order to be randomized, the patient must have blastulated embryos suitable for biopsy on day 5. Half of the patients will received 24 chromosome PGD and will have 2 PGD normal embryos transferred. Half the the patients will receive no PGD and the 2 morphologically best embryos will be transferred. Follow up on pregnant patients will be a blood draw at approximately 9 weeks gestation and buccal swabs collected from the infant(s).
- Keywords
- PGD, IVF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control (no PGD) | Receive their planned IVF treatment without PGD. 2 morphologically best embryos are transferred. | |
| Case (PGD) | Receive PGD in addition to their planned IVF Cycle. 2 morphologically best PGD normal embryos are transferred. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Implantation Rate Per Embryo Transferred
Implantation rate per embryo transferred
Measured: Within 1 year
Secondary outcomes (1)
Clinical Pregnancy Rate and Delivery Rate per Treatment Cycle
Clinical Pregnancy Rate and Delivery Rate per Treatment Cycle
Measured: Within 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 startAug 2009
- Primary completionJun 2013
- Study completionJun 2013
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 Effect of PGD on Implantation Rates in IVF CyclesStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 334 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
- NCT01219283
- Sponsor's protocol ID
- RCT-2009-01
- Status last verified
- Mar 2015
- First submitted
- 8 Oct 2010
- Last updated
- 26 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Scott RT Jr, Upham KM, Forman EJ, Hong KH, Scott KL, Taylor D, Tao X, Treff NR. Blastocyst biopsy with comprehensive chromosome screening and fresh embryo transfer significantly increases in vitro fertilization implantation and delivery rates: a randomized controlled trial. Fertil Steril. 2013 Sep;100(3):697-703. doi: 10.1016/j.fertnstert.2013.04.035. Epub 2013 Jun 1.
PubMed 23731996
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Clinical Trial to Determine the Efficacy of 24 Chromosome Preimplantation Genetic Diagnosis
- ClinicalTrials.gov ID
- NCT01219283
- Acronym / sponsor ID
- RCT-2009-01
- Keywords
- PGD, IVF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (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.
The purpose of this study is to determine if 24 chromosome preimplantation genetic diagnosis (PGD) increases implantation and delivery rates in couples attempting to conceive through in vitro fertilization (IVF).
Detailed description
FISH based PGD techniques have provided little improvement in implantation and delivery rates. We believe that the use of 24 chromosome PGD, as compared to control (no PGD) will show a benefit to patients. This study is a randomized clinical trial that seeks to validate 24 chromosome PGD.
Patients that meet the eligibility criteria will be randomized prior to embryo transfer. In order to be randomized, the patient must have blastulated embryos suitable for biopsy on day 5. Half of the patients will received 24 chromosome PGD and will have 2 PGD normal embryos transferred. Half the the patients will receive no PGD and the 2 morphologically best embryos will be transferred. Follow up on pregnant patients will be a blood draw at approximately 9 weeks gestation and buccal swabs collected from the infant(s).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (no PGD) | – | –Receive their planned IVF treatment without PGD. 2 morphologically best embryos are transferred. |
| Case (PGD) | – | –Receive PGD in addition to their planned IVF Cycle. 2 morphologically best PGD normal embryos are transferred. |
Who may qualify
- Ages
- 21 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 500 patients attempting conception through IVF who have a maximum of one prior failed IVF cycle.
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
Sustained Implantation Rate Per Embryo Transferred
Time frame: Within 1 year
Implantation rate per embryo transferred
1 secondary outcome
Clinical Pregnancy Rate and Delivery Rate per Treatment Cycle
Time frame: Within 1 Year
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 26 Mar 2015.
- Derived from this study: PubMed 23731996Scott RT Jr, Upham KM, Forman EJ, Hong KH, Scott KL, Taylor D, Tao X, Treff NR. Blastocyst biopsy with comprehensive chromosome screening and fresh embryo transfer significantly increases in vitro fertilization implantation and delivery rates: a randomized controlled trial. Fertil Steril. 2013 Sep;100(3):697-703. doi: 10.1016/j.fertnstert.2013.04.035. Epub 2013 Jun 1.
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 Effect of PGD on Implantation Rates in IVF Cycles, 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?
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 26 Mar 2015. 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?
Sustained Implantation Rate Per Embryo Transferred (time frame: Within 1 year). 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 NCT01219283, 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 26 Mar 2015.