NCT04501003

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Ufuk University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-12-12
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2020-08-06
• Last updated: 2020-11-25

Locations

1 site across 1 country: Turkey (Türkiye)