Investigation of U1-A Uterine Anomalies Implantation Markers From the Lateral Walls of the Endometrium

Infertility, Female Clinical Trial

Official title:

Investigation of Implantation Markers of Anomalies Classified as U1-A Uterine According to ESHRE/ESGE Classification of Female Genital Tractus Anomalies in Biopsy Specimens Obtained From the Lateral Walls of the Endometrium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04501003
• Other study ID #: E1/190/2019
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2019
• Est. completion date: May 2021

Study information

• Verified date: November 2020
• Source: Ufuk University
• Contact: Sezin Oral Yildiz, M.D.
• Phone: +905374459898
• Email: drsezinoral[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Various types and classes of uterine malformations have been identified and the ESHRE / ESGE classification system has recently been published on female genital system anomalies. Postoperative positive pregnancy results were obtained in studies conducted in patients with infertility, recurrent implantation failure, and recurrent pregnancy loss, which were not previously described in T-shaped uterine anomalies. Considering the increase in endometrial gland and vascularity after the surgical procedure performed in these patients, our primary goal in our study is to compare the number of implantation markers (αVβ3 integrin) and subepithelial glands in the specimen biopsies taken from the lateral walls of the endometrium before and after hysteroscopic surgery in patients with class U1a anomalies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: May 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. 18-45 age,

2. Have no systemic disease,

3. ESGE U1-A having uterine anomaly,

4. Primary infertile, recurrent implantation loss, recurrent pregnancy loss history,

5. Not having previous uterine surgery.

Exclusion Criteria:

1. Patients over the age of 45 under the age of 18,

2. Those with systemic disease (Hypertension, Heart Disease, Asthma, Renal Disease, Liver Disease, Epilepsy),

3. Having previous uterine surgery,

4. Those who gave birth.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Genital Tract Anomalies
• Infertility
• Infertility, Female
• T-Shaped Uterus

Intervention

Device:
• Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen)
With the bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen. Germany), a single incision was made from the bottom of the ostium onto the lateral walls up to the isthmus, with both lateral horns perpendicular to myometrium. The depth of the incision was between 5 and 7 mm. The cavity was widened to be triangular and symmetrical. Both tubal ostium surgeries were clearly observed at the end of the surgery. All patients were discharged on the day of surgery and no hormonal therapy and intrauterine balloon was applied after surgery. Approximately 3 months after the hysteroscopic T-shaped operation, an office hysteroscopy operation was planned to control patients in the secretory phase, to perform uterine cavity and post-operative fly control and to receive post-operative control endometrial biopsy specimens.

Locations

Country	Name	City	State
Turkey	Ufuk University	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ufuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (18)

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Barranger E, Gervaise A, Doumerc S, Fernandez H. Reproductive performance after hysteroscopic metroplasty in the hypoplastic uterus: a study of 29 cases. BJOG. 2002 Dec;109(12):1331-4. — View Citation

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Dey SK, Lim H, Das SK, Reese J, Paria BC, Daikoku T, Wang H. Molecular cues to implantation. Endocr Rev. 2004 Jun;25(3):341-73. Review. — View Citation

Fox NS, Roman AS, Stern EM, Gerber RS, Saltzman DH, Rebarber A. Type of congenital uterine anomaly and adverse pregnancy outcomes. J Matern Fetal Neonatal Med. 2014 Jun;27(9):949-53. doi: 10.3109/14767058.2013.847082. Epub 2013 Nov 26. — View Citation

Garbin O, Ohl J, Bettahar-Lebugle K, Dellenbach P. Hysteroscopic metroplasty in diethylstilboestrol-exposed and hypoplastic uterus: a report on 24 cases. Hum Reprod. 1998 Oct;13(1O):2751-5. — View Citation

Giacomucci E, Bellavia E, Sandri F, Farina A, Scagliarini G. Term delivery rate after hysteroscopic metroplasty in patients with recurrent spontaneous abortion and T-shaped, arcuate and septate uterus. Gynecol Obstet Invest. 2011;71(3):183-8. doi: 10.1159/000317266. Epub 2010 Dec 11. — View Citation

Grimbizis GF, Gordts S, Di Spiezio Sardo A, Brucker S, De Angelis C, Gergolet M, Li TC, Tanos V, Brölmann H, Gianaroli L, Campo R. The ESHRE/ESGE consensus on the classification of female genital tract congenital anomalies. Hum Reprod. 2013 Aug;28(8):2032-44. doi: 10.1093/humrep/det098. Epub 2013 Jun 14. — View Citation

Katz Z, Ben-Arie A, Lurie S, Manor M, Insler V. Beneficial effect of hysteroscopic metroplasty on the reproductive outcome in a 'T-shaped' uterus. Gynecol Obstet Invest. 1996;41(1):41-3. — View Citation

Kaufman RH, Binder GL, Gray PM Jr, Adam E. Upper genital tract changes associated with exposure in utero to diethylstilbestrol. Am J Obstet Gynecol. 1977 May 1;128(1):51-9. — View Citation

Lessey BA. Two pathways of progesterone action in the human endometrium: implications for implantation and contraception. Steroids. 2003 Nov;68(10-13):809-15. Review. — View Citation

Paradisi R, Barzanti R, Fabbri R. The techniques and outcomes of hysteroscopic metroplasty. Curr Opin Obstet Gynecol. 2014 Aug;26(4):295-301. doi: 10.1097/GCO.0000000000000077. Review. — View Citation

Tan BK, Vandekerckhove P, Kennedy R, Keay SD. Investigation and current management of recurrent IVF treatment failure in the UK. BJOG. 2005 Jun;112(6):773-80. Review. — View Citation

Urman B, Yakin K, Balaban B. Recurrent implantation failure in assisted reproduction: how to counsel and manage. A. General considerations and treatment options that may benefit the couple. Reprod Biomed Online. 2005 Sep;11(3):371-81. Review. — View Citation

Valle RF, Ekpo GE. Hysteroscopic metroplasty for the septate uterus: review and meta-analysis. J Minim Invasive Gynecol. 2013 Jan-Feb;20(1):22-42. doi: 10.1016/j.jmig.2012.09.010. Erratum in: J Minim Invasive Gynecol. 2013 Nov-Dec;20(6):917-8. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of endometrial lateral wall biopsies before and after hysteroscopic metroplasty in patients with T-shaped uterus.	From the endometrium biopsies taken before and after the operation, the implantation marker beta 3 integrin was examined to determine if there was any change in the implantation.	Baseline