Clinical trial NCT04109846: Pregnancy and Developmental Outcomes After Transfer of Reportedly Aneuploid or Mosaic Embryos
Official title: Transfer of Aneuploid or Mosaic Embryos Following Preimplantation Genetic Testing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Aneuploidy
Mosaicism
Pregnancy Outcome
Keywords: Preimplantation Genetic Testing for Aneuploidy
Preimplantation Genetic Screening
embryo transfer
mosaic
aneuploid
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients desiring frozen embryo transfer or aneuploid or mosaic embryo. Patients will be counseled regarding risks and obstetric and pediatric outcomes will be collected.
Primary purpose: TREATMENT

Brief summary: To determine how often embryos reported to be abnormal by preimplantation genetic testing result in liveborn infants. To evaluate whether the pregnancies that result from these embryos are higher risk for complications and whether the resulting babies have higher risk for health or developmental issues in the first five years after birth.

Detailed description: Genetic testing modality and results will be recorded

Pregnancy per transfer will be recorded

Patients in the study agree to provide medical records of their pregnancy.

Any genetic testing or fetal testing will be carefully reviewed and recorded by the study team.

For patients with live births, pediatric records will be collected for up to 5 years.

As well as surveys for developmental milestones.

There is no financial compensation for study participants

Eligibility criteria: Inclusion Criteria:

* Available aneuploid or mosaic embryos
* No other acceptable embryos available
* Willing to travel to Stanford for treatment
* English language fluency

Exclusion Criteria:

* Use of international donor eggs or sperm not tested according to FDA guidelines.
* Living outside the United States
* Embryos with Triploidy are not eligible for transfer in this protocol

Primary outcomes:
measure: Pregnancy Rate
timeFrame: 3 years
Secondary outcomes:
measure: Live birth rate
timeFrame: 4 years
measure: Obstetric complications
timeFrame: 4 years
measure: Pediatric Development
timeFrame: 7 years 3 months
Other outcomes:
Locations:
city: Sunnyvale
country: United States
facility: Stanford Fertility and Reproductive Medicine Center
state: California
Study officials:
affiliation: Stanford University
name: Ruth Lathi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Munne S, Spinella F, Grifo J, Zhang J, Beltran MP, Fragouli E, Fiorentino F. Clinical outcomes after the transfer of blastocysts characterized as mosaic by high resolution Next Generation Sequencing- further insights. Eur J Med Genet. 2020 Feb;63(2):103741. doi: 10.1016/j.ejmg.2019.103741. Epub 2019 Aug 21.
citation: Victor 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.
citation: Zhang L, Wei D, Zhu Y, Gao Y, Yan J, Chen ZJ. Rates of live birth after mosaic embryo transfer compared with euploid embryo transfer. J Assist Reprod Genet. 2019 Jan;36(1):165-172. doi: 10.1007/s10815-018-1322-2. Epub 2018 Sep 24.
citation: Munne S, Blazek J, Large M, Martinez-Ortiz PA, Nisson H, Liu E, Tarozzi N, Borini A, Becker A, Zhang J, Maxwell S, Grifo J, Babariya D, Wells D, Fragouli E. Detailed investigation into the cytogenetic constitution and pregnancy outcome of replacing mosaic blastocysts detected with the use of high-resolution next-generation sequencing. Fertil Steril. 2017 Jul;108(1):62-71.e8. doi: 10.1016/j.fertnstert.2017.05.002. Epub 2017 Jun 1.
citation: Greco E, Minasi MG, Fiorentino F. Healthy Babies after Intrauterine Transfer of Mosaic Aneuploid Blastocysts. N Engl J Med. 2015 Nov 19;373(21):2089-90. doi: 10.1056/NEJMc1500421. No abstract available.