Skip to content

The Impact of Endometrial Compaction on Assisted Reproductive Technology Outcome

The Impact of Endometrial Compaction on Assisted Reproductive Technology Outcome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04721522
Enrollment
356
Registered
2021-01-22
Start date
2021-01-29
Completion date
2024-06-01
Last updated
2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ART, Embryo Implantation

Keywords

Endometrial Compaction, endometrial receptivity, ART

Brief summary

Absence of endometrial compaction on the day of ET has adverse effects on success of ART outcome.

Detailed description

Implantation is a complex process which requires coordination and interaction between a blastocyst and the endometrium. Impaired embryo quality or impaired endometrial receptivity may negatively affect this interaction that in turn results in implantation failure (Diedrich et al., 2007). . Successful implantation entails a process of strict synchronization of endometrial and blastocyst development. (Maged et al., 2018). Despite advancements made since the introduction of assisted reproductive technology (ART), fewer than 40% of ART treatment cycles result in a live birth. Endometrial receptivity remains a crucial rate-limiting step affecting the success of ART treatment. Embryos are thought to be responsible for one-third of implantation failures, whereas the remaining two-thirds result from sub-optimal endometrial receptivity or abnormal embryo-endometrium dialogue.(Craciunas et al., 2019). There are 3 main methods used to assess endometrial receptivity: endometrial biopsy, hormone profile, and ultrasound imaging.(Lawrenz and Fatemi, 2017). Ultrasound has been established as an appreciated, simple, and non-invasive technique in evaluation of endometrial preparation before embryo transfer in IVF cycles. Several sonographic parameters have been assessed that include endometrial thickness (Ent), endometrial pattern (EnP) and sub-endometrial blood flow.(Kader et al., 2016). Endometrial thickness (EMT) is the most used prognostic factor for endometrial receptivity during ART (Kasius et al., 2014). Both clinical pregnancy and live birth rates decreased significantly for each millimeter below 8 mm in fresh IVF-ET cycles and below 7 mm frozen ET cycles (Liu et al 2018). Regarding endometrial patterns (Yuan et al., 2016) and vascularization (Ng et al., 2007) data are still contradictory. Increased frequency of contractility prior to embryo transfer was inversely related to clinical pregnancy in fresh and frozen embryo transfer cycles. (Zhu et al., 2014). Currently, there is an emphasis on a new endometrial parameter called endometrial compaction, which is the decrease in endometrial thickness on the day of ET. In a Study of 274 frozen embryo transfer cycles, patients whose endometrium compacted had a significantly higher ongoing pregnancy rate than patients whose endometrium became thicker or did not change.(Haas et al., 2019). On the other hand, a large-scale cohort study revealed that an increased endometrium thickness after progesterone administration in FET was associated with better pregnancy outcome.(Bu et al., 2019). The role of endometrial compaction in fresh ART cycles is not yet studied. So, it's better to test its effect on fresh cycles ART outcome.

Interventions

DIAGNOSTIC_TESTblood sampling & ultrasound

Blood sampling: Serum P4 & estradiol will be performed on the day of triggering and on the day of embryo transfer. Progesterone/ Estradiol (P4/E2) ratio will be calculated Ultrasound: On triggering day, at time of ovum pick up and on ET day, we will measure 1. Endometrial thickness 2. Endometrial pattern 3. Endometrial compaction: the difference in measurement of endometrial thickness between the day of embryo transfer and the day of triggering. 4. Junctional zone thickness 5. Uterine contraction (peristalsis). 6. Blood flow of uterine vessels: PI of the uterine arteries will be calculated also Endometrial - sub endometrial blood flow

Sponsors

Zagazig University
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 37 Years

Inclusion criteria

* All women should have the following: Aged from 18 - 37 years old. Undergoing fresh ICSI cycles. A normal uterus with no anomalies or pathologies. At least one good-quality embryo/blastocyst available for transfer (3 BB and more according to Gardner and Schoolcraft grading system). Easy mockup embryo transfer (i.e. the catheter is smoothly inserted without touching the fundus, no cervix tenaculum is used and the catheter is clean of blood).

Exclusion criteria

\- Younger than 18 or older than 37 years old. Congenital uterine abnormality or pathology. Presence of a hydrosalpinx. Chronic diseases which are not suitable for pregnancy. ICSI cycles with fresh or frozen TESE samples.

Design outcomes

Primary

MeasureTime frameDescription
whether the occurrence of endometrial compaction on the day of embryo transfer has a role in optimizing ongoing pregnancy rate in ART cycles2 weeksPercent of endometrial compaction will be calculated as the difference in measurement of endometrial thickness between the day of embryo transfer and the day of triggering.

Countries

Egypt

Contacts

Primary Contacteman ElGindy, MD, PhD
eman_elgindy2013@hotmail.com01227491143
Backup Contactshahenda saleh, md
shahendasaleh20102015.ss@gmail.com01001109730

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026