NCT07364526

Brief Summary

Preimplantation genetic testing for aneuploidies (PGT-A) is commonly used in IVF but requires embryo biopsy and shows limited benefit in egg donation cycles. Non-invasive PGT-A (niPGTA), based on the analysis of cell-free embryonic DNA in spent culture media, offers a promising biopsy-free alternative. This prospective, blinded study in egg donation cycles will evaluate whether niPGTA-detected aneuploidy is associated with implantation failure and pregnancy loss, assessing its potential clinical value as a non-invasive embryo selection tool.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for all trials

Timeline
19mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Feb 2026Dec 2027

First Submitted

Initial submission to the registry

January 14, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 26, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 14, 2026

Last Update Submit

January 21, 2026

Conditions

IVF

Keywords

niPGTA

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    9 months from enrolment

Secondary Outcomes (2)

  • Pregnancy rate

    2 weeks from enrolment

  • Miscarriage rate

    12 weeks from enrollment

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsRecipient of embryo transfer
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients who are going to undergo an oocyte donation cycle, who meet the inclusion/exclusion criteria and who sign the informed consent form

You may qualify if:

  • Women between 18 and 50 years old who are oocyte recipients.
  • Signed consent form
  • Transfer of a single blastocyst-stage embryo
  • Male with normal sperm FISH

You may not qualify if:

  • Uterine malformations
  • Abnormal karyotypes in either partner
  • Failure to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Bernabeu

Alicante, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

spent medium

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 23, 2026

Study Start

February 26, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

January 23, 2026

Record last verified: 2026-01

Locations

ES(1)