Impact of a Predetermined Day 5 ET vs. a Predetermined Da... | NCT06447077

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

NCT06447077

Sponsor

Infertility Treatment Center Dortmund

Status

Recruiting

Last Update Posted

Jul 24, 2025Actual

Enrollment

2,400Estimated

Phase

Not provided

Conditions

Infertility
Reproductive Issues

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 26, 2024Actual

Primary Completion Date

Jan 2028Estimated

Completion Date

Mar 2028Estimated

First Submitted Date

Jun 3, 2024

First Submission Date that Met QC Criteria

Jun 3, 2024

First Posted Date

Jun 6, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2025

Last Update Posted Date

Jul 24, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Dr. Stefan Dieterle, Principal Investigator, University of Witten/HerdeckePrincipal Investigator

Lead Sponsor

Infertility Treatment Center DortmundOTHER

Collaborators

Name	Class
Fertility Center Dortmund	UNKNOWN
novum - Center for Reproductive Medicine Essen - Duisburg	UNKNOWN
Deutsche Klinik Bad Münder	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

9 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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).

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Female patients seeking ICSI treatment because of male subfertilit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stefan Dieterle, MD	Contact	00492315575450		dieterle@kinderwunschzentrum.org
Tom Trapphoff, DR	Contact	00492315575450		trapphoff@kinderwunschzentrum.org

Overall Officials

Name	Affiliation	Role
Stefan Dieterle, MD	University of Witten/Herdecke	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Infertility treatment center Dortmund	Recruiting	Dortmund	North Rhine-Westphalia	44135	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided