Endometrial Compaction in Assissted Reproduction

NCT ID: NCT04962789

Last Updated: 2022-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 145 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-20
• Study Completion Date: 2023-10-01

Brief 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

Detailed 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

Conditions

Infertility, Female

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

with compaction

those whose endometrial thickness is calculated to decrease by the time of embryo transfer compared with the thickness at the day of ovulation trigger, analyzed according to the degree of compaction, i.e., 5%, 10%, 15%, or 20% decrease thickness

transvaginal ultrasound on the uterus

Intervention Type: DIAGNOSTIC_TEST

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

without compaction

those who had an increase in their endometrial thickness or whose thickness decreased less than 5%

transvaginal ultrasound on the uterus

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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 )

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ayman Ahmad Abdelraof Ahmad Askar

assisstant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Women Health Hospital

Asyut, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ayman Askar, master

Role: CONTACT

aaaaskar@yahoo.com

0020101 901 4640

Facility Contacts

Ayman Askar, demonstrator

Role: primary

aaaaskar@yahoo.com

00201019014640

Other Identifiers

EC

Identifier Type: -

Identifier Source: org_study_id