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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06447077

Enrollment

2400

Registered

2024-06-06

Start date

2024-06-26

Completion date

2028-03-31

Last updated

2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Reproductive Issues

Keywords

ICSI, Predetermined Day 6 Embryo Transfer, Predetermined Day 5 Embryo Transfer

Brief summary

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

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Clinical pregnancy rate per embryo transfer	4 weeks after embryo transfer	Clinical pregnancy rate per embryo transfer (detection of a gestational sac)

Secondary

Measure	Time frame	Description
Abortion rate per clinical pregnancy	During entire ongoing pregnancy	Abortion rate per clinical pregnancy (termination of an ongoing clinical pregnancy)

Countries

Germany

Contacts

Primary ContactStefan Dieterle, MD

dieterle@kinderwunschzentrum.org00492315575450

Backup ContactTom Trapphoff, DR

trapphoff@kinderwunschzentrum.org00492315575450

Outcome results