Endometrial Compaction in Assissted Reproduction

Infertility, Female Clinical Trial

Official title:

The Impact of Endometrial Compaction on Ongoing Pregnancy Rate in Assisted Reproductive Technology Cycles : Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04962789
• Other study ID #: EC
• Status: Recruiting
• Start date: August 20, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: May 2022
• Source: Assiut University
• Contact: Ayman Askar, master
• Phone: 0020101 901 4640
• Email: aaaaskar[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To record the dynamic change of endometrial thickness (Day of embryo transfer Versus. Day of ovulation trigger administration in case of fresh cycles or end of estrogen phase in frozen cycles), and to investigate the impact of endometrial thickness change on pregnancy outcomes

Description:

Clinical pregnancy rate in IVF cycles depends on embryo quality and endometrial receptivity . It is challenging to assess endometrial receptivity. Measuring endometrial thickness by ultrasonography is a simple , noninvasive and accurate method to do so. Many studies have implicated endometrial thickness and pattern as prognostic parameters for successful outcomes in IVF-ET.

Some studies have suggested a minimal thickness for a successful pregnancy to occur, while others have reported adverse effects of increased endometrial thickness above which pregnancy is unlikely to occur.

Now there is a novel hypothesis that not only the initial endometrial thickness can affect implantation rate and clinical pregnancy rate ,but also the decrease in endometrial thickness in the time interval between the ovulation triggering and the embryo transfer or what is called endometrial compaction increases the implantation and clinical pregnancy rate

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: October 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• • Infertile women aged 18 years to 40 years undergoing IVF/ ICSI for any indication.

Exclusion Criteria:

• • History of recurrent pregnancy loss (= 2 spontaneous abortions) and/or history of recurrent (= 2) ICSI failure after embryo transfer.

• Uterine malformations.

• Uncorrected hydrosalpinx.

• Intrauterine conditions affecting pregnancy outcomes such as ( intrauterine adhesions, fibroids, polyps).

• Any previous hysteroscopic surgery eg. Metroplasty or hysteroscopic myomectomy or uterine surgeries involving the endometrium eg. myomectomy during which uterine cavity was opened.

• History suggesting endometritis.

• Use of hCG for endometrial preparation or luteal phase support.

• Poor quality embryos( according to Istanbul consensus workshop on embryo assessment )

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Diagnostic Test:
• transvaginal ultrasound on the uterus
Transvaginal ultrasound measurement to record endometrial thickness 2 times in each cycle: In case of fresh cycles: 1)Day of ovulation triggering 2)Day of embryo transfer In case of frozen thawed cycles : 1)End of estrogen phase 2)Day of embryo transfer

Locations

Country	Name	City	State
Egypt	Women Health Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate	rate of ongoing pregnancy in patients who have endometrial compaction	12 weeks after embryo transfer if hCG tested positive