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

NCT04501003 | Unknown

• 1 other identifier: E1/190/2019
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

T-Shaped Uterus; Infertility, Female; Intregrin Beta 3; Genital Tract Anomalies

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen)

OTHER

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.

Device: Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen)

Interventions

Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen) DEVICE

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.

Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age,
• Have no systemic disease,
• ESGE U1-A having uterine anomaly,
• Primary infertile, recurrent implantation loss, recurrent pregnancy loss history,
• Not having previous uterine surgery.

You may not qualify if:

• Patients over the age of 45 under the age of 18,
• Those with systemic disease (Hypertension, Heart Disease, Asthma, Renal Disease, Liver Disease, Epilepsy),
• Having previous uterine surgery,
• Those who gave birth.

Sponsors & Collaborators

• Ufuk University: lead

Study Sites (1)

Ufuk University

Ankara, Çankaya, 06520, Turkey (Türkiye)

RECRUITING

Related Publications (18)

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MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Central Study Contacts

Sezin Oral Yıldız, M.D.

CONTACT

+905374459898; drsezinoral@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 6, 2020
• Study Start: December 12, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: November 25, 2020

Record last verified: 2020-11

Locations

TU (1)