Endometrial Injury In Recurrent Implantation Failure

NCT03748238 | Unknown

• 1 other identifier: 201871
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate that the efficacy of the endometrial injury before IVF in recurrent implantation failure patients.

Conditions

Infertility; Endometrial Diseases

Keywords

Recurrent implantation failure; Endometrial injury; Implantation; Hysteroscopy

Outcome Measures

Primary Outcomes (1)

• Positive Pregnancy

  Blood concentration of beta-hcg

  1month

Study Arms (2)

Injury group

EXPERIMENTAL

Endometrial injury with hysteroscopy

Procedure: Endometrial Injury with Hysteroscopy

Control group

NO INTERVENTION

No hysteroscopy

Interventions

Endometrial Injury with Hysteroscopy PROCEDURE

All office hysteroscopy procedures will be done transvaginally under sedation with a 5 mm 30 degree lens supplied with a 5 F working channel continuous flow office hysteroscope (Bettocchi office hysteroscope, Karl Storz, Tuttlingen, Germany) without speculum or tenaculum. Briefly, following cervical passage and initial endometrial cavity investigation endometrial injury will be performed without energy modality (i.e. with scissors). Endometrial injury will perform first on the fundus by cutting into the endometrium (without injuring the myometrium) transversally. Later, vertical incisions will perform 0,5 cm apart each other, on the anterior and posterior walls of the uterus, 1-1.5 cm away from the fundus and one cut for each lateral wall

Injury group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Only women with recurrent implantation failure
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women under the age of 40 who met the RIF definition
• Patients whose follicle-stimulating hormone (FSH) levels were ≤ 15 IU/mL

You may not qualify if:

• Patients with congenital uterine anomalies
• Patients with Asherman's syndrome
• Patients with uterine cavity distorted by myoma or endometrial polyps
• Patients with confirmed endometriosis or endometrioma
• Patients with BMI of \<18.5 and \>29.9

Sponsors & Collaborators

• Gurgan Clinic: lead

Study Sites (1)

Gurgan Clinic IVF and Women Health Center

Ankara, Cankaya, 06640, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Infertility; Uterine Diseases

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Ziya Kalem, MD

  Gurgan Clinic IVF and Women Health Center

  PRINCIPAL INVESTIGATOR

• Halil Ruso, Embryologist

  GurganClinic IVF and Women Health Center

  PRINCIPAL INVESTIGATOR

• Antonis Makrigiannakis, MD,Professor

  Greek University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Timur Gurgan, MD,Professor

CONTACT

0905322317706; tgurgan@gurganclinic.com.tr

Muberra Namlı Kalem, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Professor, MD

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 20, 2018
• Study Start: November 1, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)