Impact of Endometrial Compaction on Clinical Pregnancy Rate in Frozen Embryo Transfers

To find out if the percentage of endometrial compaction is correlated to clinical pregnancy rate in down regulated frozen embryo transfer cycle. Endometrial compaction is the change in endometrial thickness between the end of the estrogen only phase and the day of embryo transfer. In concept, the compaction of the endometrium after progesterone initiation indicates that the endometrium is responsive to progesterone and could therefore be used as a proxy for endometrial receptivity predictability of FET cycle outcome

Study Overview

• Status: Recruiting
• Conditions: IVF

• Study Type: Observational
• Enrollment (Estimated): 80

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Infertility patients planning for FET

Description

Inclusion Criteria:

• Women undergoing down regulated cycles frozen embryo transfer.
• Women at age group 20-35 years old.
• Day 5 embryos will be transferred.

Exclusion Criteria:

• Chromosomal abnormality in either partner (As this could lead to cycle cancellation).
• Uterine malformation or any intrauterine condition affecting the pregnancy outcomes of FET, such as endometrial polyps, uterine cavity adhesion, history of endometrial tuberculosis, hydrosalpinx with a reflux into uterine cavity (As the might not be candidates for IVF cycle till correction).
• Recurrent implantation failure, defined as 2 or more previous failed trials (Other confounding factors might of present which could affect the results).
• Cycles of patients with persistent endometrial thickness <7mm during treatment protocol (Due to cycled cancelation).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy rate	Clinical pregnancy rate, determined by visualizing a viable embryo within the uterine cavity by ultrasound 3-4 weeks after ET, in patients with endometrial compaction in down regulated FET cycles in comparison to non endometrial compaction.	3-4 wks after ET

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of change of endometrial thickness between the end of estrogen administration only phase and the day of embryo transfer.	3-4 wks after ET
Chemical pregnancy rates, detected by positive hCG test in the absence of pregnancy findings on TVUS	3-4 wks after ET
Number of estrogen administration days	10 days before ET

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: September 1, 2024
• First Submitted That Met QC Criteria: September 1, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: September 1, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Endometrial Compaction

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No