Endometrial Compaction in Assissted Reproduction

• Conditions: Infertility, Female
• Interventions: Diagnostic Test: transvaginal ultrasound on the uterus

• Registration Number: NCT04962789
• Lead Sponsor: Assiut University

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

Study Timeline

• Study First Submitted: 2021-07-10
• Study First Submitted QC: 2021-07-10
• Study First Posted: 2021-07-15
• Study Start: 2021-08-20
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-12
• Last Update Posted: 2022-05-13
• Primary Completion: 2023-08-01
• Study Completion: 2023-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 145

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 )

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
with compaction	transvaginal ultrasound on the uterus	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
without compaction	transvaginal ultrasound on the uterus	those who had an increase in their endometrial thickness or whose thickness decreased less than 5%

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	12 weeks after embryo transfer if hCG tested positive	rate of ongoing pregnancy in patients who have endometrial compaction

Trial Locations

Locations (1)

Women Health Hospital; 🇪🇬 Assiut, Egypt