Clinical trial NCT06447077: Impact of a Predetermined Day 5 ET vs. a Predetermined Day 6 ET on Clinical Pregnancy Rate After ICSI Treatment
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
Reproductive Issues
Keywords: ICSI
Predetermined Day 6 Embryo Transfer
Predetermined Day 5 Embryo Transfer
Lead sponsor: Infertility Treatment Center Dortmund
Sponsor class: OTHER
Collaborators: name: Fertility Center Dortmund
name: novum - Center for Reproductive Medicine Essen - Duisburg
name: Deutsche Klinik Bad Münder
First posted: 2024-06-06
Enrollment: 2400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients seeking ICSI treatment because of male subfertilit

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).

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

Primary outcomes:
measure: Clinical pregnancy rate per embryo transfer
timeFrame: 4 weeks after embryo transfer
Secondary outcomes:
measure: Abortion rate per clinical pregnancy
timeFrame: During entire ongoing pregnancy
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: Infertility treatment center Dortmund
state: NRW
Study officials:
affiliation: University of Witten/Herdecke
name: Stefan Dieterle, MD
role: PRINCIPAL_INVESTIGATOR
References: