InfertilityPROV-ETNCT03604107
Predictive Value of Embryonic Testing
An observational study of Infertility, run by Reproductive Medicine Associates of New Jersey at 4 sites in United States.
Trial summary
The primary objective of this study is to determine the predictive value of preimplantation genetic screening (PGS) as a marker of embryonic competence. Secondary objectives are to define the related or independent predictive values of other proposed markers of embryonic and maternal reproductive competence in… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Preimplantation Genetic Testing-Aneuploidy
- How many people
- 237 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Jul 2018to 1 Dec 2020
- 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 42 years
- Women only
- Adult
Study population: Infertile couples attempting conception through in vitro fertilization
Who may be able to join
- Couples electing embryonic aneuploidy screening (PGS)
- Couples electing single embryo transfer
Who cannot join
- Any prior failed IVF cycle
- Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
- Diagnosis of chronic endometritis
- Maximum day 3 FSH level of 12 or higher
- Anti-mullerian hormone level less than 0.5 g/mL, tested within previous year
- Total basal antral follicle count less than 8 follicles
Show all 16Show fewer
- Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
- BMI <18.5 or > 35
- Personal history of recurrent pregnancy loss (two or more pregnancy losses)
- Use of oocyte donation
- Use of gestational carrier
- Medical condition predisposing patient to high risk pregnancy
- Use of surgical procedures to obtain sperm
- Presence of hydrosalpinges that communicate with endometrial cavity
- Any contraindications to undergoing in vitro fertilization or gonadotropin stimulation
- Single gene disorder or chromosomal rearrangement requiring a more detailed embryonic genetic analysis
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Reproductive Medicine Associates of Pennsylvania
Allentown, Pennsylvania, 18104
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07960
Reproductive Medicine Associates of Florida
Lake Mary, Florida, 32746
Reproductive Medicine Associates of Philadelphia
Philadelphia, Pennsylvania, 19107
About this study
Official title: Evaluation of the Efficacy of Preimplantation Genetic Screening (PGS) in Predicting Embryonic Ploidy and Subsequent Pregnancy Outcomes in in Vitro Fertilization (IVF) Cycles
The primary objective of this study is to determine the predictive value of preimplantation genetic screening (PGS) as a marker of embryonic competence. Secondary objectives are to define the related or independent predictive values of other proposed markers of embryonic and maternal reproductive competence in assisted reproductive technology (ART) cycles.
Read the detailed description
Patients participating in the study will undergo a routine in vitro fertilization cycle. Trophectoderm biopsy will be performed on all blastocysts however biopsy samples will not be analyzed till the clinical outcome has been determined. The single, morphologically best embryo available will be selected for transfer. All clinical and laboratory care is identical to that of which subjects would receive if they were not participating in the study. This includes all pretreatment screening, in-cycle treatment, embryology procedures, single embryo transfer, pregnancy testing, and pregnancy follow-up (if pregnancy occurs).
- Conditions
- Infertility
- Being tested
- Preimplantation Genetic Testing-Aneuploidy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preimplantation Genetic Testing-AneuploidyGenetic
trophectoderm biopsy samples will be analyzed for karyotype after clinical outcome is determined
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Value of Aneuploidy Screening
Determine confidence intervals that a euploid embryo will implant, an aneuploid embryo will not implant, and the likelihood of mosaic and segmental aneuploid embryos implanting and describe their outcomes.
Measured: approximately 1 month post clinical outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start30 Jul 2018
- Primary completion30 Sep 2020
- Study completion1 Dec 2020
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 InfertilityStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 237 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 Jr., MD, HCLD, Principal investigator, IVI RMA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604107
- Sponsor's protocol ID
- RMA-2018-01
- Acronym
- PROV-ET
- Status last verified
- Jan 2022
- First submitted
- 14 Jun 2018
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tiegs AW, Tao X, Zhan Y, Whitehead C, Kim J, Hanson B, Osman E, Kim TJ, Patounakis G, Gutmann J, Castelbaum A, Seli E, Jalas C, Scott RT Jr. A multicenter, prospective, blinded, nonselection study evaluating the predictive value of an aneuploid diagnosis using a targeted next-generation sequencing-based preimplantation genetic testing for aneuploidy assay and impact of biopsy. Fertil Steril. 2021 Mar;115(3):627-637. doi: 10.1016/j.fertnstert.2020.07.052. Epub 2020 Aug 28.
PubMed 32863013
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Preimplantation Genetic Screening (PGS) in Predicting Embryonic Ploidy and Subsequent Pregnancy Outcomes in in Vitro Fertilization (IVF) Cycles
- ClinicalTrials.gov ID
- NCT03604107
- Acronym / sponsor ID
- PROV-ET / RMA-2018-01
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 27 Jul 2018 (actual)
- 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 primary objective of this study is to determine the predictive value of preimplantation genetic screening (PGS) as a marker of embryonic competence. Secondary objectives are to define the related or independent predictive values of other proposed markers of embryonic and maternal reproductive competence in assisted reproductive technology (ART) cycles.
Detailed description
Patients participating in the study will undergo a routine in vitro fertilization cycle. Trophectoderm biopsy will be performed on all blastocysts however biopsy samples will not be analyzed till the clinical outcome has been determined. The single, morphologically best embryo available will be selected for transfer. All clinical and laboratory care is identical to that of which subjects would receive if they were not participating in the study. This includes all pretreatment screening, in-cycle treatment, embryology procedures, single embryo transfer, pregnancy testing, and pregnancy follow-up (if pregnancy occurs).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Infertile couples attempting conception through in vitro fertilization
Key inclusion criteria (2 listed)
- Couples electing embryonic aneuploidy screening (PGS)
- Couples electing single embryo transfer
Key exclusion criteria (16 listed)
- Any prior failed IVF cycle
- Diagnosis of endometrial insufficiency: prior cycle with maximal endometrial thickness ≤ 6mm, abnormal endometrial pattern (failure to attain a trilaminar appearance), persistent endometrial fluid
- Diagnosis of chronic endometritis
- Maximum day 3 FSH level of 12 or higher
- Anti-mullerian hormone level less than 0.5 g/mL, tested within previous year
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 |
|---|---|---|
| Preimplantation Genetic Testing-Aneuploidytrophectoderm biopsy samples will be analyzed for karyotype after clinical outcome is determined | Genetic | – |
Primary outcome
Predictive Value of Aneuploidy Screening
Time frame: approximately 1 month post clinical outcome
Determine confidence intervals that a euploid embryo will implant, an aneuploid embryo will not implant, and the likelihood of mosaic and segmental aneuploid embryos implanting and describe their outcomes.
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 14 Jan 2022.
- Derived from this study: PubMed 32863013Tiegs AW, Tao X, Zhan Y, Whitehead C, Kim J, Hanson B, Osman E, Kim TJ, Patounakis G, Gutmann J, Castelbaum A, Seli E, Jalas C, Scott RT Jr. A multicenter, prospective, blinded, nonselection study evaluating the predictive value of an aneuploid diagnosis using a targeted next-generation sequencing-based preimplantation genetic testing for aneuploidy assay and impact of biopsy. Fertil Steril. 2021 Mar;115(3):627-637. doi: 10.1016/j.fertnstert.2020.07.052. Epub 2020 Aug 28.
- Individual participant dataSharing planned: No
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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 Jr., MD, HCLD principal investigator
IVI RMA
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Reproductive Medicine Associates of New Jersey at 4 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 2 inclusion and 16 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 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Predictive Value of Aneuploidy Screening (time frame: approximately 1 month post clinical outcome). 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 NCT03604107, 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 14 Jan 2022.