The Impact of Endometrial Compaction on Assisted Reproductive Technology Outcome

NCT04721522 | Recruiting

• 1 other identifier: 6549
• Study Type: observational
• Target: 356
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Embryo Implantation; ART

Keywords

Endometrial Compaction; endometrial receptivity; ART

Outcome Measures

Primary Outcomes (1)

• whether the occurrence of endometrial compaction on the day of embryo transfer has a role in optimizing ongoing pregnancy rate in ART cycles

  Percent 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.

  2 weeks

Study Arms (1)

356 case will be enrolled

Pituitary suppression will be achieved by long or antagonist protocol. For long protocol, GnRH agonist will be administered for 10-14 days starting from mid-luteal phase of preceding cycle. After confirmation of down regulation, gonadotropins will be given from second or third day of cycle in a daily dose of (150-300 IU). Gonadotropins therapy will be tailored according to age, BMI, antral follicle count, antimullerian hormone and previous response. In antagonist protocol, gonadotropins will be given from second or third day of cycle in a daily dose of (150-300 IU). GnRH antagonist will be adjusted according to patient response. On the 5th -6th day of stimulation, sonography will be performed and repeated every 1-3 days with regular estradiol assessment. When at least 3 follicles reach ≥ 17 mm in mean diameter, trigger will be given. Oocytes pick up will be performed 34-36 hour after triggering.

Diagnostic Test: blood sampling & ultrasound

Interventions

blood sampling & ultrasound DIAGNOSTIC_TEST

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

356 case will be enrolled

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

It will be carried out in the department of Obstetrics and Gynecology, Zagazig University and in a private center.

You may qualify if:

• 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).

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university

Zagazig, 44511, Egypt

RECRUITING

Related Publications (12)

• Diedrich K, Fauser BC, Devroey P, Griesinger G; Evian Annual Reproduction (EVAR) Workshop Group. The role of the endometrium and embryo in human implantation. Hum Reprod Update. 2007 Jul-Aug;13(4):365-77. doi: 10.1093/humupd/dmm011. Epub 2007 Jun 4.

  PMID: 17548368 BACKGROUND

• Maged AM, Rashwan H, AbdelAziz S, Ramadan W, Mostafa WAI, Metwally AA, Katta M. Randomized controlled trial of the effect of endometrial injury on implantation and clinical pregnancy rates during the first ICSI cycle. Int J Gynaecol Obstet. 2018 Feb;140(2):211-216. doi: 10.1002/ijgo.12355. Epub 2017 Nov 18.

  PMID: 29048754 BACKGROUND

• Craciunas L, Gallos I, Chu J, Bourne T, Quenby S, Brosens JJ, Coomarasamy A. Conventional and modern markers of endometrial receptivity: a systematic review and meta-analysis. Hum Reprod Update. 2019 Mar 1;25(2):202-223. doi: 10.1093/humupd/dmy044.

  PMID: 30624659 BACKGROUND

• Lawrenz B, Fatemi HM. Effect of progesterone elevation in follicular phase of IVF-cycles on the endometrial receptivity. Reprod Biomed Online. 2017 Apr;34(4):422-428. doi: 10.1016/j.rbmo.2017.01.011. Epub 2017 Jan 24.

  PMID: 28162937 BACKGROUND

• Kader MA, Abdelmeged A, Mahran A, Samra MFA, Bahaa H (2016) The usefulness of endometrial thickness, morphology, and vasculature by 2D Doppler ultrasound in prediction of pregnancy in IVF/ICSI cycles. Egypt J Radiol Ncl Med 47(1):341-346.

  BACKGROUND

• Kasius A, Smit JG, Torrance HL, Eijkemans MJ, Mol BW, Opmeer BC, Broekmans FJ. Endometrial thickness and pregnancy rates after IVF: a systematic review and meta-analysis. Hum Reprod Update. 2014 Jul-Aug;20(4):530-41. doi: 10.1093/humupd/dmu011. Epub 2014 Mar 23.

  PMID: 24664156 BACKGROUND

• Liu KE, Hartman M, Hartman A, Luo ZC, Mahutte N. The impact of a thin endometrial lining on fresh and frozen-thaw IVF outcomes: an analysis of over 40 000 embryo transfers. Hum Reprod. 2018 Oct 1;33(10):1883-1888. doi: 10.1093/humrep/dey281.

  PMID: 30239738 BACKGROUND

• Yuan X, Saravelos SH, Wang Q, Xu Y, Li TC, Zhou C. Endometrial thickness as a predictor of pregnancy outcomes in 10787 fresh IVF-ICSI cycles. Reprod Biomed Online. 2016 Aug;33(2):197-205. doi: 10.1016/j.rbmo.2016.05.002. Epub 2016 May 13.

  PMID: 27238372 BACKGROUND

• Ng EH, Chan CC, Tang OS, Yeung WS, Ho PC. Endometrial and subendometrial vascularity is higher in pregnant patients with livebirth following ART than in those who suffer a miscarriage. Hum Reprod. 2007 Apr;22(4):1134-41. doi: 10.1093/humrep/del458. Epub 2006 Dec 5.

  PMID: 17148577 BACKGROUND

• Zhu L, Che HS, Xiao L, Li YP. Uterine peristalsis before embryo transfer affects the chance of clinical pregnancy in fresh and frozen-thawed embryo transfer cycles. Hum Reprod. 2014 Jun;29(6):1238-43. doi: 10.1093/humrep/deu058. Epub 2014 Mar 23.

  PMID: 24664129 BACKGROUND

• Haas J, Smith R, Zilberberg E, Nayot D, Meriano J, Barzilay E, Casper RF. Endometrial compaction (decreased thickness) in response to progesterone results in optimal pregnancy outcome in frozen-thawed embryo transfers. Fertil Steril. 2019 Sep;112(3):503-509.e1. doi: 10.1016/j.fertnstert.2019.05.001. Epub 2019 Jun 24.

  PMID: 31248618 BACKGROUND

• Bu Z, Yang X, Song L, Kang B, Sun Y. The impact of endometrial thickness change after progesterone administration on pregnancy outcome in patients transferred with single frozen-thawed blastocyst. Reprod Biol Endocrinol. 2019 Nov 25;17(1):99. doi: 10.1186/s12958-019-0545-0.

  PMID: 31767010 BACKGROUND

MeSH Terms

Interventions

Blood Specimen Collection; Ultrasonography

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Diagnostic Imaging

Study Officials

• rana nabil, Msc

  zagazig university hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

eman ElGindy, MD, PhD

CONTACT

01227491143; eman_elgindy2013@hotmail.com

shahenda saleh, md

CONTACT

01001109730; shahendasaleh20102015.ss@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of obstetrics and gynaecology

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 22, 2021
• Study Start: January 29, 2021
• Primary Completion: May 20, 2024
• Study Completion: June 1, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

EG (1)