NCT07499453

Brief Summary

The main aim of this study is to evaluate the impact and identify potential indications for sequential double embryo transfer (SEQ-ET) in couples undergoing assisted reproductive technology (ART). The study will compare live birth rates (LBR) between patients receiving SEQ-ET and those receiving standard double embryo transfer (DET), while assessing safety outcomes and potential indications, including endometrial immune under-activation. Each SEQ-ET case will be matched with a DET control based on age, transfer attempt rank, and ART technique. We hypothesize that SEQ-ET may enhance implantation in couples with previous ART failures without increasing the risk of complications, potentially through localized maternal-endometrial immune communication initiated by the initially transferred cleavage-stage embryos.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
778

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

9.9 years

First QC Date

March 24, 2026

Last Update Submit

March 24, 2026

Conditions

Keywords

IVFSequential embryo transferLive birth rate

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    LBR defined as delivery of a viable infant beyond 24 weeks of gestation, assessed after the first fresh or frozen blastocyst transfer.

    From first embryo transfer to delivery (up to approximately 9 months).

Secondary Outcomes (4)

  • Clinical Pregnancy Rate

    6-8 weeks after embryo transfer.

  • Miscarriage Rate per Clinical Pregnancy

    Up to 24 weeks of gestation.

  • Implantation Rate

    6-8 weeks after embryo transfer.

  • Multiple pregnancies

    Up to 9 months

Study Arms (2)

Case group

Patients who underwent a SEQ-ET of one or two cleavage-stage embryos (day 2/3) followed by the transfer of a blastocyst-stage embryo (day 5/6) within the same cycle.

Control group

Patient who underwent a simultaneous DET defined as the transfer of two blastocyst-stage embryos (day 5 or day 6) in the same cycle.

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of couples undergoing assisted reproductive technology (ART) at Pierre Rouquès - Les Bluets Hospital between January 2014 and December 2023. Female participants are biologically capable of becoming pregnant and have undergone either sequential double embryo transfer (SEQ-ET) or standard double embryo transfer (DET). The population includes women with a history of previous ART attempts, and does not exclude participants based on the presence or absence of a specific disease or condition.

You may qualify if:

  • Infertile patients undergoing IVF with planned SEQ-ET or DET.
  • Age ≤ 42 years.

You may not qualify if:

  • Age aged 43 years.
  • Cycles in which only a single embryo was ultimately transferred and cycles in which no embryo transfer occurred.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Pierre Rouquès - Les Bluets.

Paris, 75012, France

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2026

First Posted

March 30, 2026

Study Start

January 1, 2014

Primary Completion

December 1, 2023

Study Completion

September 1, 2024

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations