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NCT Number: NCT06447077

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

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Infertility treatment center Dortmund

Dortmund, North Rhine-Westphalia, 44135, Germany

Location status: Recruiting

Location contact

Stefan Dieterle

CONTACT

00492315575450

Stefan Dieterle

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Clinical pregnancy rate per embryo transfer

    Time frame: 4 weeks after embryo transfer

    Clinical pregnancy rate per embryo transfer (detection of a gestational sac)

Secondary outcomes

  1. Abortion rate per clinical pregnancy

    Time frame: During entire ongoing pregnancy

    Abortion rate per clinical pregnancy (termination of an ongoing clinical pregnancy)

Study contacts

Contact information is provided by the study sponsor or research team.

Stefan Dieterle, MD

CONTACT

[email protected]

00492315575450

Tom Trapphoff, DR

CONTACT

[email protected]

00492315575450

Sponsors and collaborators

Lead sponsor

Infertility Treatment Center Dortmund

Other

Collaborators

  • Deutsche Klinik Bad Münder
  • Fertility Center Dortmund
  • novum - Center for Reproductive Medicine Essen - Duisburg

Registry information

Official study title

Impact of a Predetermined Day 5 Embryo Transfer Versus a Predetermined Day 6 Embryo Transfer on the Clinical Pregnancy Rate After Intracytoplasmic Sperm Injection (ICSI) Treatment

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 6, 2024
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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