The Impact of Endometrial Compaction on Assisted Reproductive Technology Outcome
NCT ID: NCT04721522
Last Updated: 2024-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
356 participants
OBSERVATIONAL
2021-01-29
2024-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Endometrial Compaction in Assissted Reproduction
NCT04962789
Effect of Dilatation and Curettage on the Endometrial Receptivity
NCT03485235
Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes
NCT01040351
Physical Endometrial Manipulation and Its Effect on ICSI
NCT03345251
Assessment of Endometrial and Sub-endometrial Vascularity Before and After PRP Infusion in Frozen Embryo Transfer Cycles
NCT04247204
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Despite advancements made since the introduction of assisted reproductive technology (ART), fewer than 40% of ART treatment cycles result in a live birth. Endometrial receptivity remains a crucial rate-limiting step affecting the success of ART treatment. Embryos are thought to be responsible for one-third of implantation failures, whereas the remaining two-thirds result from sub-optimal endometrial receptivity or abnormal embryo-endometrium dialogue.(Craciunas et al., 2019).
There are 3 main methods used to assess endometrial receptivity: endometrial biopsy, hormone profile, and ultrasound imaging.(Lawrenz and Fatemi, 2017). Ultrasound has been established as an appreciated, simple, and non-invasive technique in evaluation of endometrial preparation before embryo transfer in IVF cycles. Several sonographic parameters have been assessed that include endometrial thickness (Ent), endometrial pattern (EnP) and sub-endometrial blood flow.(Kader et al., 2016).
Endometrial thickness (EMT) is the most used prognostic factor for endometrial receptivity during ART (Kasius et al., 2014). Both clinical pregnancy and live birth rates decreased significantly for each millimeter below 8 mm in fresh IVF-ET cycles and below 7 mm frozen ET cycles (Liu et al 2018). Regarding endometrial patterns (Yuan et al., 2016) and vascularization (Ng et al., 2007) data are still contradictory. Increased frequency of contractility prior to embryo transfer was inversely related to clinical pregnancy in fresh and frozen embryo transfer cycles. (Zhu et al., 2014).
Currently, there is an emphasis on a new endometrial parameter called endometrial compaction, which is the decrease in endometrial thickness on the day of ET. In a Study of 274 frozen embryo transfer cycles, patients whose endometrium compacted had a significantly higher ongoing pregnancy rate than patients whose endometrium became thicker or did not change.(Haas et al., 2019).
On the other hand, a large-scale cohort study revealed that an increased endometrium thickness after progesterone administration in FET was associated with better pregnancy outcome.(Bu et al., 2019). The role of endometrial compaction in fresh ART cycles is not yet studied. So, it's better to test its effect on fresh cycles ART outcome.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
blood sampling & ultrasound
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
blood sampling & ultrasound
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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).
Exclusion Criteria
18 Years
37 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Zagazig University
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rana Nabil Mohamed Attia
Assistant lecturer of obstetrics and gynaecology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
rana nabil, Msc
Role: PRINCIPAL_INVESTIGATOR
zagazig university hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Zagazig university
Zagazig, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
6549
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.