InfertilityNCT04472156
A Prospective Study of a Mosaic Embryo Transfer
A study testing Transfer of mosaic embryo in people with Infertility, run by Colorado Center for Reproductive Medicine at 1 site in United States.
Trial summary
This research is a prospective study in which the purpose is to investigate the clinical outcomes following the transfer of a mosaic embryo (presence of both chromosomally normal and abnormal cells) that has been screened for preimplantation genetic testing (PGT). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Transfer of mosaic embryo
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women age 18-45 Infertile women who have completed an IVF cycle with PGT at the Colorado Center for Reproductive Medicine (CCRM) that have a mosaic embryo
- Patients can be of any race, culture, sexual orientation or ethnicity
- Patients that are willing to transfer a single embryo
Who cannot join
- Patients that do not meet the clinical requirements for an embryo transfer per clinic standards.
- Patients that desire more than a single embryo transfer.
- Patients that are using a gestational carrier.
- Embryonic mosaic PGT results that include chromosome errors 13, 18, 21
- Patients that did not complete their IVF with PGT cycle at the Colorado Center for Reproductive Medicine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Colorado Center for Reproductive Medicine
Lone Tree, Colorado, 80124
Rachel Makloski, RN, TriggerStudy@colocrm.com
About this study
This research is a prospective study in which the purpose is to investigate the clinical outcomes following the transfer of a mosaic embryo (presence of both chromosomally normal and abnormal cells) that has been screened for preimplantation genetic testing (PGT).
Read the detailed description
This research is a prospective study with the purpose is to investigate the clinical outcomes following the transfer of a mosaic embryo (presence of both chromosomally normal and abnormal cells) that has been screened for preimplantation genetic testing (PGT). PGT involves the biopsy and testing of a handful (3-6) of trophectoderm (pre-placental cells) from the embryo. Embryos that are screened as mosaic via PGT, as a standard, are not offered for transfer for pregnancy attempt. Publications have shown that mosaic embryos and mosaic fetuses can result in healthy live births (Wallerstein et al, 2015; Victor et al, 2019). Ongoing clinical outcomes are important to further understand the association between an embryonic mosaic biopsy of pre-placental cells and subsequent fetal chromosomal constitution. Implantation rates and live birth rates will be evaluated to help understand if mosaic embryos should routinely be offered for transfer to patients attempting pregnancy.
- Conditions
- Infertility
- Being tested
- Transfer of mosaic embryo
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfer of mosaic embryoProcedure or surgery
Subjects will transfer a mosaic embryo transferred to their uterus
| Study group | Role | What they receive |
|---|---|---|
| Transfer of mosaic embryo | Experimental | Women will have a mosaic embryo transferred to their uterus after in vitro fertilization (IVF) with pre implantation genetic testing completed at Colorado Center for Reproductive Medicine. Receives: Procedure: Transfer of mosaic embryo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Implantation rate
Ultrasound will be performed 2-3 weeks after initial positive pregnancy test to confirm viable pregnancy as evidenced by gestational sac in the uterus with a fetal heat rate
Measured: 3-4 weeks after embryo transfer
Live birth rate
Live birth rate will be evaluated
Measured: 9-12 months post embryo transfer
Secondary outcomes (6)
Miscarriage Rates
The rate of miscarriage will be evaluated associated with a mosaic embryo transfer
Measured: 5-12 months post embryo transfer
Products of conception from miscarriage
Products of conception will be karyotyped if available following a miscarriage and compared to that of previous PGT testing if the patient is willing to have the testing.
Measured: 2-9 months post embryo transfer
Pregnancy complications
Patient will be evaluated after delivery to assess if patient had any complications associated with the pregnancy. This will be completed with telephone interview
Measured: 9-12 months post embryo transfer
Stillbirth rates associated with Mosaic Embryo Transfer
The rate of stillbirths with will be evaluated among patients who have had a mosaic embryo transfer
Measured: 9-12 months post embryo transfer
Prenatal testing
If available, we will request any results of prenatal testing of karyotype that was obtained via Amniocentesis or Chorionic Villa Sampling (CVS)
Measured: 9-12 months post embryo transfer
Neonatal Outcomes
Patient will be contacted to assess the health of the infant, noting any medical problems if any that the baby has.
Measured: 12-15 months after birth of baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start15 Oct 2020
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Not applicable
- Intervention model
- Single group
- Model description
- Outcomes will be evaluated with women who have a mosaic embryo transferred
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colorado Center for Reproductive Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mandy Katz-Jaffe, Colorado Center for Reproductive Medicine
- Investigators
- Mandy Katz-Jaffe, PhD, Principal investigator, Fertility Genetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472156
- Sponsor's protocol ID
- Mosaic
- Status last verified
- Feb 2024
- First submitted
- 9 Jul 2020
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wallerstein R, Misra S, Dugar RB, Alem M, Mazzoni R, Garabedian MJ. Current knowledge of prenatal diagnosis of mosaic autosomal trisomy in amniocytes: karyotype/phenotype correlations. Prenat Diagn. 2015 Sep;35(9):841-7. doi: 10.1002/pd.4620. Epub 2015 Jun 23.
PubMed 25976239Victor AR, Tyndall JC, Brake AJ, Lepkowsky LT, Murphy AE, Griffin DK, McCoy RC, Barnes FL, Zouves CG, Viotti M. One hundred mosaic embryos transferred prospectively in a single clinic: exploring when and why they result in healthy pregnancies. Fertil Steril. 2019 Feb;111(2):280-293. doi: 10.1016/j.fertnstert.2018.10.019.
PubMed 30691630
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of a Mosaic Embryo Transfer
- ClinicalTrials.gov ID
- NCT04472156
- Acronym / sponsor ID
- Mosaic
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Colorado Center for Reproductive MedicineUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 15 Jul 2020 (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.
This research is a prospective study in which the purpose is to investigate the clinical outcomes following the transfer of a mosaic embryo (presence of both chromosomally normal and abnormal cells) that has been screened for preimplantation genetic testing (PGT).
Detailed description
This research is a prospective study with the purpose is to investigate the clinical outcomes following the transfer of a mosaic embryo (presence of both chromosomally normal and abnormal cells) that has been screened for preimplantation genetic testing (PGT). PGT involves the biopsy and testing of a handful (3-6) of trophectoderm (pre-placental cells) from the embryo. Embryos that are screened as mosaic via PGT, as a standard, are not offered for transfer for pregnancy attempt. Publications have shown that mosaic embryos and mosaic fetuses can result in healthy live births (Wallerstein et al, 2015; Victor et al, 2019). Ongoing clinical outcomes are important to further understand the association between an embryonic mosaic biopsy of pre-placental cells and subsequent fetal chromosomal constitution. Implantation rates and live birth rates will be evaluated to help understand if mosaic embryos should routinely be offered for transfer to patients attempting pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Outcomes will be evaluated with women who have a mosaic embryo transferred
| Arm | Type | Receives |
|---|---|---|
| Transfer of mosaic embryo | Experimental | Procedure: Transfer of mosaic embryoWomen will have a mosaic embryo transferred to their uterus after in vitro fertilization (IVF) with pre implantation genetic testing completed at Colorado Center for Reproductive Medicine. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women age 18-45 Infertile women who have completed an IVF cycle with PGT at the Colorado Center for Reproductive Medicine (CCRM) that have a mosaic embryo
- Patients can be of any race, culture, sexual orientation or ethnicity
- Patients that are willing to transfer a single embryo
Key exclusion criteria (5 listed)
- Patients that do not meet the clinical requirements for an embryo transfer per clinic standards.
- Patients that desire more than a single embryo transfer.
- Patients that are using a gestational carrier.
- Embryonic mosaic PGT results that include chromosome errors 13, 18, 21
- Patients that did not complete their IVF with PGT cycle at the Colorado Center for Reproductive Medicine.
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 |
|---|---|---|
| Transfer of mosaic embryoSubjects will transfer a mosaic embryo transferred to their uterus | Procedure or surgery | Transfer of mosaic embryo |
Primary outcome
Evaluation of Implantation rate
Time frame: 3-4 weeks after embryo transfer
Ultrasound will be performed 2-3 weeks after initial positive pregnancy test to confirm viable pregnancy as evidenced by gestational sac in the uterus with a fetal heat rate
Live birth rate
Time frame: 9-12 months post embryo transfer
Live birth rate will be evaluated
6 secondary outcomes
Miscarriage Rates
Time frame: 5-12 months post embryo transfer
Products of conception from miscarriage
Time frame: 2-9 months post embryo transfer
Pregnancy complications
Time frame: 9-12 months post embryo transfer
Stillbirth rates associated with Mosaic Embryo Transfer
Time frame: 9-12 months post embryo transfer
Prenatal testing
Time frame: 9-12 months post embryo transfer
Neonatal Outcomes
Time frame: 12-15 months after birth of baby
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 25976239Wallerstein R, Misra S, Dugar RB, Alem M, Mazzoni R, Garabedian MJ. Current knowledge of prenatal diagnosis of mosaic autosomal trisomy in amniocytes: karyotype/phenotype correlations. Prenat Diagn. 2015 Sep;35(9):841-7. doi: 10.1002/pd.4620. Epub 2015 Jun 23.
- Background: PubMed 30691630Victor AR, Tyndall JC, Brake AJ, Lepkowsky LT, Murphy AE, Griffin DK, McCoy RC, Barnes FL, Zouves CG, Viotti M. One hundred mosaic embryos transferred prospectively in a single clinic: exploring when and why they result in healthy pregnancies. Fertil Steril. 2019 Feb;111(2):280-293. doi: 10.1016/j.fertnstert.2018.10.019.
- 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.
Mandy Katz-Jaffe, PhD principal investigator
Fertility Genetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transfer of mosaic embryo in people with Infertility, run by Colorado Center for Reproductive Medicine at 1 site 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Makloski, RN (303-788-8300 ext. 1769, rmakloski@colocrm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Implantation rate (time frame: 3-4 weeks after embryo transfer). 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 NCT04472156, which also lists 2 linked publications.
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 29 Feb 2024.