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

NCT06447077 | Recruiting

• 1 other identifier: ET d5 vs d6
• Study Type: observational
• Target: 2,400
• Locations: 1 country
• Sites: 1

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).

Conditions

Infertility; Reproductive Issues

Keywords

ICSI; Predetermined Day 6 Embryo Transfer; Predetermined Day 5 Embryo Transfer

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate per embryo transfer

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

  4 weeks after embryo transfer

Secondary Outcomes (1)

• Abortion rate per clinical pregnancy

  During entire ongoing pregnancy

Study Arms (2)

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).

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients seeking ICSI treatment because of male subfertilit

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• Infertility Treatment Center Dortmund: lead
• Fertility Center Dortmund: collaborator
• novum - Center for Reproductive Medicine Essen - Duisburg: collaborator
• Deutsche Klinik Bad Münder: collaborator

Study Sites (1)

Infertility treatment center Dortmund

Dortmund, North Rhine-Westphalia, 44135, Germany

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Stefan Dieterle, MD

  University of Witten/Herdecke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan Dieterle, MD

CONTACT

00492315575450; dieterle@kinderwunschzentrum.org

Tom Trapphoff, DR

CONTACT

00492315575450; trapphoff@kinderwunschzentrum.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 6, 2024
• Study Start: June 26, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)