InfertilityNCT01732900
Gene Expression in Cumulus Cells to Predict Pregnancy
A study testing Morphology and GemART assay in people with Infertility, run by Gema Diagnostics at 4 sites in United States.
Trial summary
The purpose of this study is to determine the performance of a genetic assay, GemART, in cumulus cells predictive of embryo viability, and pregnancy success in women undergoing in vitro fertilization (IVF). Read more about this study
- Who is it for?
- Ages 21 to 39 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Morphology and GemART assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2013to Mar 2014
- Phase
- Interventional
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Aged 21-39 years
- IVF cycle 1 or 2
- BMI <35
- Fertilization method: ICSI and/or IVF
- Day 3 or day 5 embryo transfer
- Treatment cycle intended for single or double embryo transfer
Show all 10Show fewer
- Use own oocytes, not oocyte donor
- ≥ 3 embryos at final assessment
- Donor sperm acceptable
- Willing to comply with protocol and study procedures
Who cannot join
- Polycystic Ovarian Syndrome
- Presence of fibroid(s): >4 cm intramural or submucosal fibroids
- History of chemotherapy or radiation to the abdomen or pelvis
- Use of donor oocytes
- Use of reinseminated oocytes
- Preimplantation genetic diagnosis or preimplantation genetic screening during current IVF cycle
Show all 9Show fewer
- Concurrent participation in another clinical study
- (Male): Surgically removed sperm
- (Male): <5 million sperm count
Trial locations and contacts
4 sites in 1 country.
United States4 sites
IVF Indiana
Indianapolis, Indiana, 46280
University of Iowa
Iowa City, Iowa, 52242
Reproductive Medicine Institute
Oak Brook, Illinois, 60523
Reproductive Medicine Associates of Michigan
Troy, Michigan, 48084
About this study
Official title: The Predictive Value of a Gene Expression Signature in Cumulus Cells Indicative of Embryo Implantation.
The purpose of this study is to determine the performance of a genetic assay, GemART, in cumulus cells predictive of embryo viability, and pregnancy success in women undergoing in vitro fertilization (IVF). Performance is defined as success rate per embryo transferred, as measured by the implantation rate of embryos transferred.
- Conditions
- Infertility
- Being tested
- Morphology, GemART assay
- Keywords
- In vitro fertilization, Assisted reproduction, pregnancy outcome, cumulus cells
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphologyOther
Embryos selected for transfer will be based upon morphology alone.
GemART assayOther
Embryos selected for transfer will be based upon morphology and GemART assay.
| Study group | Role | What they receive |
|---|---|---|
| Morphology | Active comparator | Embryos selected for transfer will be based on morphology alone. Receives: Other: Morphology |
| GemART assay | Experimental | Embryos selected for transfer will be based upon morphology and GemART assay. Receives: Other: GemART assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Clinical pregnancy, recorded as either positive or negative, will be determined using vaginal ultrasound during post-transfer week 4-9. Clinical Pregnancy rate for embryos selected using the GemART assay in conjunction with morphology will be compared with clinical pregnancy rate for embryos selected using morphology alone.
Measured: Recorded at post-transfer week 4-9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startFeb 2013
- Primary completionMar 2014
- Study completionMar 2014
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gema Diagnostics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Jarrett, MD, Principal investigator, IVF Indiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732900
- Sponsor's protocol ID
- GEMA-201201
- Status last verified
- Jul 2014
- First submitted
- 14 Nov 2012
- Last updated
- 14 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Iager AE, Kocabas AM, Otu HH, Ruppel P, Langerveld A, Schnarr P, Suarez M, Jarrett JC, Conaghan J, Rosa GJ, Fernandez E, Rawlins RG, Cibelli JB, Crosby JA. Identification of a novel gene set in human cumulus cells predictive of an oocyte's pregnancy potential. Fertil Steril. 2013 Mar 1;99(3):745-752.e6. doi: 10.1016/j.fertnstert.2012.10.041. Epub 2012 Nov 29.
PubMed 23200692
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of a Gene Expression Signature in Cumulus Cells Indicative of Embryo Implantation.
- ClinicalTrials.gov ID
- NCT01732900
- Acronym / sponsor ID
- GEMA-201201
- Conditions
- Infertility
- Keywords
- In vitro fertilization, Assisted reproduction, pregnancy outcome, cumulus cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Gema DiagnosticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 26 Nov 2012 (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 the performance of a genetic assay, GemART, in cumulus cells predictive of embryo viability, and pregnancy success in women undergoing in vitro fertilization (IVF). Performance is defined as success rate per embryo transferred, as measured by the implantation rate of embryos transferred.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphology | Active comparator | Other: MorphologyEmbryos selected for transfer will be based on morphology alone. |
| GemART assay | Experimental | Other: GemART assayEmbryos selected for transfer will be based upon morphology and GemART assay. |
Who may qualify
- Ages
- 21 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Aged 21-39 years
- IVF cycle 1 or 2
- BMI <35
- Fertilization method: ICSI and/or IVF
- Day 3 or day 5 embryo transfer
Key exclusion criteria (9 listed)
- Polycystic Ovarian Syndrome
- Presence of fibroid(s): >4 cm intramural or submucosal fibroids
- History of chemotherapy or radiation to the abdomen or pelvis
- Use of donor oocytes
- Use of reinseminated oocytes
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 |
|---|---|---|
| MorphologyEmbryos selected for transfer will be based upon morphology alone. | Other | Morphology |
| GemART assayEmbryos selected for transfer will be based upon morphology and GemART assay. | Other | GemART assay |
Primary outcome
Clinical pregnancy rate
Time frame: Recorded at post-transfer week 4-9
Clinical pregnancy, recorded as either positive or negative, will be determined using vaginal ultrasound during post-transfer week 4-9. Clinical Pregnancy rate for embryos selected using the GemART assay in conjunction with morphology will be compared with clinical pregnancy rate for embryos selected using morphology alone.
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 Jul 2014.
- Background: PubMed 23200692Iager AE, Kocabas AM, Otu HH, Ruppel P, Langerveld A, Schnarr P, Suarez M, Jarrett JC, Conaghan J, Rosa GJ, Fernandez E, Rawlins RG, Cibelli JB, Crosby JA. Identification of a novel gene set in human cumulus cells predictive of an oocyte's pregnancy potential. Fertil Steril. 2013 Mar 1;99(3):745-752.e6. doi: 10.1016/j.fertnstert.2012.10.041. Epub 2012 Nov 29.
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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.
John Jarrett, MD principal investigator
IVF Indiana
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphology and GemART assay in people with Infertility, run by Gema Diagnostics 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 10 inclusion and 9 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 Jul 2014. 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?
Clinical pregnancy rate (time frame: Recorded at post-transfer week 4-9). 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 NCT01732900, 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 Jul 2014.