InfertilityNCT06447077
Impact of a Predetermined Day 5 ET vs. a Predetermined Day 6 ET on Clinical Pregnancy Rate After ICSI Treatment
An observational study of Infertility and Reproductive Issues, run by Infertility Treatment Center Dortmund at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Reproductive Issues
- How many people
- 2,400 participants
- Where
- 1 siteGermany
- Study dates
- 26 Jun 2024to Mar 2028
- How long will I take part?
- 9 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Female patients seeking ICSI treatment because of male subfertilit
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Infertility treatment center Dortmund
Dortmund, North Rhine-Westphalia, 44135
Stefan Dieterle, 00492315575450
Stefan Dieterle
About this study
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
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).
Read the 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).
- Conditions
- Infertility, Reproductive Issues
- Keywords
- ICSI, Predetermined Day 6 Embryo Transfer, Predetermined Day 5 Embryo Transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate per embryo transfer
Clinical pregnancy rate per embryo transfer (detection of a gestational sac)
Measured: 4 weeks after embryo transfer
Secondary outcomes (1)
Abortion rate per clinical pregnancy
Abortion rate per clinical pregnancy (termination of an ongoing clinical pregnancy)
Measured: During entire ongoing pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start26 Jun 2024
- Primary completionJan 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Infertility Treatment Center Dortmund
- Sponsor type
- University, hospital or other
- Collaborators
- Fertility Center Dortmund, novum - Center for Reproductive Medicine Essen - Duisburg, Deutsche Klinik Bad Münder, MVZ Kinderwunschzentrum Godesberger Allee, Kinderwunsch Centrum München, MVZ Fertility Center Berlin
- Responsible party
- Principal investigator, Prof. Dr. Stefan Dieterle, University of Witten/Herdecke
- Investigators
- Stefan Dieterle, MD, Principal investigator, University of Witten/Herdecke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447077
- Sponsor's protocol ID
- ET d5 vs d6
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No