Impact of a Predetermined Day 5 ET vs. a Predetermined Day 6 ET on Clinical Pregnancy Rate After ICSI Treatment

NCT ID: NCT06447077

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-26

Study Completion Date

2028-03-31

Brief Summary

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The aim of this prospective multicenter study is to investigate the influence of a predetermined embryo transfer on day 6 compared to a predetermined embryo transfer on day 5. The study population consists of the control group (predetermined embryo transfer on day 5) and the study group (predetermined embryo transfer on day 6). The primary endpoint is the clinical pregnancy rate (detection of a gestational sac) per embryo transfer and the secondary endpoint is the abortion rate per clinical pregnancy. The data from the multicenter study are obtained at three test centers (Fertility Center Dortmund, Fertility Center Essen and Fertility Center Bad Münder).

Detailed Description

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Since a predetermined embryo transfer on day 5 cannot be performed in some centers on every day of the week (e.g. sunday), some IVF centers perform a predetermined embryo transfer on day 4 or day 6, respepectively. Data for a predetermined embryo transfer on day 4 versus a predetermined embryo transfer on day 5 showed no significant differences regarding clinical pregnancy rates. However, since a day 6 transfer might offer advantages in assessing the development stage, the prolonged culture and transfer on day 6 transfer might be a very promising option.

As of yet, there are no prospective studies in the current literature examining the equivalence of a predetermined embryo transfer on day 6 versus a predetermined embryo transfer on day 5.

The aim of this prospective multicenter study is to investigate the influence of a predetermined embryo transfer on day 6 compared to a predetermined embryo transfer on day 5. The study population consists of the control group (predetermined embryo transfer on day 5) and the study group (predetermined embryo transfer on day 6). The primary endpoint is the clinical pregnancy rate (detection of a gestational sac) per embryo transfer and the secondary endpoint is the abortion rate per clinical pregnancy. The data from the multicenter study are obtained at three test centers (Fertility Center Dortmund, Fertility Center Essen and Fertility Center Bad Münder).

Conditions

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Infertility Reproductive Issues

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Predetermined embryo transfer on day 5

The control group will include patients who have their oocyte pick-up on a monday (embryo transfer on saturday, day 5), wednesday (embryo transfer on monday, day 5), thursday (embryo transfer on tuesday, day 5), friday (embryo transfer on wednesday, day 5) and saturday (embryo transfer on thursday, day 5).

No interventions assigned to this group

Predetermined embryo transfer on day 6

The study group will include patients who have their oocyte pick-up on a tuesday (embryo transfer on monday, day 6).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

The patients to be included should be ≥18 years old. There is no upper age limit. Only ICSI treatments with a single embryo transfer (SET) should be included. Only the first cycle per patient should be evaluated.

Exclusion Criteria

none
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fertility Center Dortmund

UNKNOWN

Sponsor Role collaborator

novum - Center for Reproductive Medicine Essen - Duisburg

UNKNOWN

Sponsor Role collaborator

Deutsche Klinik Bad Münder

UNKNOWN

Sponsor Role collaborator

Infertility Treatment Center Dortmund

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Stefan Dieterle

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan Dieterle, MD

Role: PRINCIPAL_INVESTIGATOR

University of Witten/Herdecke

Locations

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Infertility treatment center Dortmund

Dortmund, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Stefan Dieterle, MD

Role: CONTACT

00492315575450

Tom Trapphoff, DR

Role: CONTACT

00492315575450

Facility Contacts

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Stefan Dieterle

Role: primary

00492315575450

Other Identifiers

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ET d5 vs d6

Identifier Type: -

Identifier Source: org_study_id

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