Preimplantation Gentic Screening (PGS)Phase 4IPSONCT01194531
Impact of Parental Support on Pregnancy Outcomes (IPSO) Trial- Day 3 Preimplantation Genetic Screening (PGS) With Day 5 Fresh Transfer
A Phase 4 study testing 24 Chromosome Aneuploidy Screening with Parental Support in people with Preimplantation Gentic Screening (PGS) and In Vitro Fertilization (IVF), run by Natera, Inc. at 9 sites in United States.
Trial summary
Natera is recruiting patients for a research study evaluating pregnancy and implantation rates in women undergoing In Vitro Fertilization (IVF) and Preimplantation Genetic Screening (PGS). PGS is also referred to as Preimplantation Genetic Diagnosis (PGD) for aneuploidy. Read more about this study
- Who is it for?
- Ages 35 to 42 years, women only
- Conditions the study is for
- Preimplantation Gentic Screening (PGS), In Vitro Fertilization (IVF), Preimplantation Genetic Diagnosis (PGD)
- What is being tested?
- 24 Chromosome Aneuploidy Screening with Parental Support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 9 sitesUnited States
- Study dates
- Sep 2010to Apr 2013
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Must agree to a follow-up visit at approximately 4-8 weeks gestation and a follow up phone call at 20 and 40 weeks gestation/livebirth. For patients assigned to the TEST group must agree to PGD testing and collection of buccal swab sample on newborn
- At least 10 eggs retrieved
- Must agree to use only Ferring products during stimulation
- Normal uterine cavity detected on hysterosalpingogram (HSG), saline infusion sonogram (SIS), or hysteroscopy
- Signed consent form
Who cannot join
- FSH ≥10 IU/L within past year prior to screening
- 2 or more previously failed IVF cycles
- Gestational or surrogate carrier, donor oocyte, donor sperm
- History of recurrent pregnancy loss (3 or more consecutive miscarriages)
- Severe male factor infertility defined as ejaculate sperm of < 1million sperm/ml, or sperm obtained through testicular biopsy
- Gender selection as primary indication
Show all 11Show fewer
- Maternal disease that is not clinically stable and known to impact the ability to become pregnant or carry a pregnancy to term (lupus, chronic liver or kidney disease, body mass index (BMI) >35, uncontrolled hypertension, anti-phospholipid antibody, thrombophilia, insulin dependent diabetes)
- Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests
- Participation in any experimental drug study within 30 days prior to Screening
- Prior hypersensitivity to any of the protocol drugs
- Known history conveying increased risk for chromosome abnormality (beyond maternal age) or genetic disease in offspring
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Atlanta Center for Reproductive Medicine
Atlanta, Georgia, 30328
Boston IVF
Boston, Massachusetts, 02451
Main Line Fertility
Bryn Mawr, Pennsylvania, 19010-3121
Fertility Centers of Illinois
Chicago, Illinois, 60610
Florida Fertility Institute/ Women's Medical Research Group, LLC
Clearwater, Florida, 33759
Fertility Specialist of Houston
Houston, Texas, 77054
Huntington Reproductive Center
Laguna Hills, California, 92653
The Nevada Center for Reproductive Medicine
Reno, Nevada, 89511
Shady Grove Fertility RSC
Washington D.C., District of Columbia, 20006
About this study
Official title: IPSO Trial - Impact of Parental Support on Pregnancy Outcomes: A Multi-Center, Randomized, Open-Label Study to Evaluate the Implantation and Pregnancy Rates Following 24 Chromosome Aneuploidy Screening With Parental Support in Patients Undergoing In Vitro Fertilization (IVF)
Natera is recruiting patients for a research study evaluating pregnancy and implantation rates in women undergoing In Vitro Fertilization (IVF) and Preimplantation Genetic Screening (PGS). PGS is also referred to as Preimplantation Genetic Diagnosis (PGD) for aneuploidy.
Healthy women undergoing IVF who are between the ages of 35 to 42 years are being recruited to participate in a randomized study.
Read more
The purpose of this study is to determine whether PGS- testing of embryos created during IVF for chromosomal abnormalities, prior to transfer to the uterus- improves pregnancy and implantation rates in patients when compared to patients whose embryos are not tested. PGS will be conducted using 24 Chromosome Aneuploidy Screening with Parental Support from Natera.
All subjects who qualify and enroll will receive discounted IVF medications (both TEST and CONTROL arms). If you become pregnant during the study, you will receive a small payment for providing information about your pregnancy and birth. If you are assigned to the TEST arm of the study you will receive free PGS.
Read the detailed description
If you meet the criteria below, you may be a candidate for this study. To participate in the study you must:
- Be a healthy, pre-menopausal female, 35-42 years of age
- Have a history of less than 3 consecutive miscarriages and no more than one failed IVF cycle
- Agree to use Ferring Pharmaceutical products during stimulation
- Agree to be randomly assigned to either the arm of the study receiving PGS (TEST arm)or the arm receiving no additional testing (CONTROL arm)
Additional screening will be conducted to determine if you are eligible to enroll.
All subjects who qualify and enroll will receive discounted IVF medications. If you become pregnant during the study, you will receive a small payment for providing information about your pregnancy and birth. If you are assigned to the TEST arm of the study you will receive free PGS.
- Conditions
- Preimplantation Gentic Screening (PGS), In Vitro Fertilization (IVF), Preimplantation Genetic Diagnosis (PGD)
- Being tested
- 24 Chromosome Aneuploidy Screening with Parental Support
- Keywords
- Preimplantation Gentic Screening, PGS, In Vitro Fertilization, IVF, Preimplantation Genetic Diagnosis, PGD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 Chromosome Aneuploidy Screening with Parental SupportDevice
Also called Preimplantation Genetic Diagnosis (PGD)
Preimplantation Genetic Screening (PGS)
| Study group | Role | What they receive |
|---|---|---|
| CONTROL arm | No intervention | Subjects assigned to this arm of the study will receive no PGS testing. |
| TEST arm | Other | Subjects assigned to this arm of the study will receive PGS testing. Receives: Device: 24 Chromosome Aneuploidy Screening with Parental Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implantation Rate
Implantation rate is defined as the ratio between the number of gestational sacs with a fetal heartbeat and the total number of embryos transferred.
Measured: Data is collected at approximately 4-6 weeks gestation, 20 weeks gestation and 40 weeks gestation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: Slow enrollment and Natera is transitioning to a new PGS testing platform.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Preimplantation Gentic Screening (PGS)Studies of the same condition, open and under way.
- More trials run by Natera, Inc.The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ferring Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01194531
- Sponsor's protocol ID
- IVF006-D3
- Acronym
- IPSO
- Status last verified
- Nov 2014
- First submitted
- 2 Aug 2010
- Last updated
- 25 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IPSO Trial - Impact of Parental Support on Pregnancy Outcomes: A Multi-Center, Randomized, Open-Label Study to Evaluate the Implantation and Pregnancy Rates Following 24 Chromosome Aneuploidy Screening With Parental Support in Patients Undergoing In Vitro Fertilization (IVF)
- ClinicalTrials.gov ID
- NCT01194531
- Acronym / sponsor ID
- IPSO / IVF006-D3
- Conditions
- Preimplantation Gentic Screening (PGS), In Vitro Fertilization (IVF), Preimplantation Genetic Diagnosis (PGD)
- Keywords
- Preimplantation Gentic Screening, PGS, In Vitro Fertilization, IVF, Preimplantation Genetic Diagnosis, PGD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment and Natera is transitioning to a new PGS testing platform.
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Natera, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ferring Pharmaceuticals
- Study start
- Sep 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Sep 2010 (estimated)
- Results
- Posted 13 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Natera is recruiting patients for a research study evaluating pregnancy and implantation rates in women undergoing In Vitro Fertilization (IVF) and Preimplantation Genetic Screening (PGS). PGS is also referred to as Preimplantation Genetic Diagnosis (PGD) for aneuploidy.
Healthy women undergoing IVF who are between the ages of 35 to 42 years are being recruited to participate in a randomized study.
The purpose of this study is to determine whether PGS- testing of embryos created during IVF for chromosomal abnormalities, prior to transfer to the uterus- improves pregnancy and implantation rates in patients when compared to patients whose embryos are not tested. PGS will be conducted using 24 Chromosome Aneuploidy Screening with Parental Support from Natera.
All subjects who qualify and enroll will receive discounted IVF medications (both TEST and CONTROL arms). If you become pregnant during the study, you will receive a small payment for providing information about your pregnancy and birth. If you are assigned to the TEST arm of the study you will receive free PGS.
Detailed description
If you meet the criteria below, you may be a candidate for this study. To participate in the study you must:
- Be a healthy, pre-menopausal female, 35-42 years of age
- Have a history of less than 3 consecutive miscarriages and no more than one failed IVF cycle
- Agree to use Ferring Pharmaceutical products during stimulation
- Agree to be randomly assigned to either the arm of the study receiving PGS (TEST arm)or the arm receiving no additional testing (CONTROL arm)
Additional screening will be conducted to determine if you are eligible to enroll.
All subjects who qualify and enroll will receive discounted IVF medications. If you become pregnant during the study, you will receive a small payment for providing information about your pregnancy and birth. If you are assigned to the TEST arm of the study you will receive free PGS.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CONTROL arm | No intervention | –Subjects assigned to this arm of the study will receive no PGS testing. |
| TEST arm | Other | Device: 24 Chromosome Aneuploidy Screening with Parental SupportSubjects assigned to this arm of the study will receive PGS testing. |
Who may qualify
- Ages
- 35 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Must agree to a follow-up visit at approximately 4-8 weeks gestation and a follow up phone call at 20 and 40 weeks gestation/livebirth. For patients assigned to the TEST group must agree to PGD testing and collection of buccal swab sample on newborn
- At least 10 eggs retrieved
- Must agree to use only Ferring products during stimulation
- Normal uterine cavity detected on hysterosalpingogram (HSG), saline infusion sonogram (SIS), or hysteroscopy
- Signed consent form
Key exclusion criteria (11 listed)
- FSH ≥10 IU/L within past year prior to screening
- 2 or more previously failed IVF cycles
- Gestational or surrogate carrier, donor oocyte, donor sperm
- History of recurrent pregnancy loss (3 or more consecutive miscarriages)
- Severe male factor infertility defined as ejaculate sperm of < 1million sperm/ml, or sperm obtained through testicular biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24 Chromosome Aneuploidy Screening with Parental SupportAlso: Preimplantation Genetic Diagnosis (PGD)Preimplantation Genetic Screening (PGS) | Device | TEST arm |
Primary outcome
Implantation Rate
Time frame: Data is collected at approximately 4-6 weeks gestation, 20 weeks gestation and 40 weeks gestation.
Implantation rate is defined as the ratio between the number of gestational sacs with a fetal heartbeat and the total number of embryos transferred.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 24 Chromosome Aneuploidy Screening with Parental Support in people with Preimplantation Gentic Screening (PGS) and In Vitro Fertilization (IVF), run by Natera, Inc. at 9 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 25 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Implantation Rate (time frame: Data is collected at approximately 4-6 weeks gestation, 20 weeks gestation and 40 weeks gestation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2014.