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NCT06447077 Clinical Trial

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

Infertility Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06447077
Other study ID # ET d5 vs d6
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 2024
Est. completion date March 2028

Study information
Verified date June 2024
Source Infertility Treatment Center Dortmund
Contact Stefan Dieterle, MD
Phone 00492315575450
Email dieterle@kinderwunschzentrum.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 2400
Est. completion date March 2028
Est. primary completion date January 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (4)
Lead Sponsor Collaborator
Infertility Treatment Center Dortmund Deutsche Klinik Bad Münder, Fertility Center Dortmund, novum - Center for Reproductive Medicine Essen - Duisburg

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical pregnancy rate per embryo transfer Clinical pregnancy rate per embryo transfer (detection of a gestational sac) 4 weeks after embryo transfer
Secondary Abortion rate per clinical pregnancy Abortion rate per clinical pregnancy (termination of an ongoing clinical pregnancy) During entire ongoing pregnancy
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