Pregnancy and Developmental Outcomes After Transfer of Reportedly Aneuploid or Mosaic Embryos

Not Applicable

Recruiting

• Conditions: Mosaicism; Aneuploidy
• Interventions: Other: Euploid Transfer; Other: Non-euploid embryo transfer

• Registration Number: NCT04109846
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2019-04-11
• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2019-09-27
• Study First Posted: 2019-09-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-26
• Primary Completion: 2035-04
• Study Completion: 2039-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Euploid Transfer	Euploid Transfer	Patients desiring pregnancy who are undergoing euploid embryo transfer
Non-euploid Transfer	Non-euploid embryo transfer	Patients desiring pregnancy who have no acceptable euploid embryos available for transfer who chose to undergo embryo transfer of a non-euploid embryo (either aneuploid or mosaic).

Primary Outcome Measures

Name	Time	Method
Pregnancy Rate	3 years	Number participants who undergo embryo transfers that lead to a positive pregnancy test

Secondary Outcome Measures

Name	Time	Method
Live birth rate	4 years	Number participants who conceive after embryo transfer and have a live birth.
Obstetric complications	4 years	Number of participants who have a maternal of fetal complication after embryo transfer
Pediatric Development	7 years 3 months	Number of newborns and children who have abnormal pediatric development at 3 months, 2 years and 5 years following birth

Trial Locations

Locations (1)

Stanford Fertility and Reproductive Medicine Center; 🇺🇸 Sunnyvale, California, United States