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

Ufuk University

Status: Unknown

Conditions: Genital Tract Anomalies; T-Shaped Uterus; Infertility, Female

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04501003

E1/190/2019

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen)

Other group

Description:

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.

Treatment:

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