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Endometrial Injury In Recurrent Implantation Failure

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ClinicalTrials.gov Identifier: NCT03748238
Recruitment Status : Recruiting
First Posted : November 20, 2018
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Muberra Namlı Kalem, Gurgan Clinic

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

Condition or disease Intervention/treatment Phase
Infertility Endometrial Diseases Procedure: Endometrial Injury with Hysteroscopy Not Applicable

Detailed Description:
This is a prospective and randomized controlled trial investigating the effect of hysteroscopic endometrial injury for treatment of recurrent implantation failure. Approximately 230 patients who had failed to achieve a clinical pregnancy after the transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles to a woman under the age of 40 years will be randomized into two groups. Injury group will receive endometrial injury during their hysteroscopic procedure, whereas the control group (n=115) did not. This study will investigate that, whether the endometrial injury is beneficial in recurrent implantation failure patients to increase the odds of clinical pregnancy rates, live birth rates, and implantation rates.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Systematic And Standardized Hysteroscopic Endometrial Injury For Treatment Of Recurrent Implantation Failure
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
Experimental: Injury group
Endometrial injury with hysteroscopy
Procedure: Endometrial Injury with Hysteroscopy
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

No Intervention: Control group
No hysteroscopy



Primary Outcome Measures :
  1. Positive Pregnancy [ Time Frame: 1month ]
    Blood concentration of beta-hcg



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women with recurrent implantation failure
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03748238


Contacts
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Contact: Timur Gurgan, MD,Professor 0905322317706 tgurgan@gurganclinic.com.tr
Contact: Muberra Namlı Kalem, MD

Locations
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Turkey
Gurgan Clinic IVF and Women Health Center Recruiting
Ankara, Cankaya, Turkey, 06640
Contact: Ziya Kalem, MD    0905326922383    ziyakalem@hotmail.com   
Sponsors and Collaborators
Gurgan Clinic
Investigators
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Principal Investigator: 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

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Responsible Party: Muberra Namlı Kalem, Assoc Professor, MD, Gurgan Clinic
ClinicalTrials.gov Identifier: NCT03748238     History of Changes
Other Study ID Numbers: 201871
First Posted: November 20, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Muberra Namlı Kalem, Gurgan Clinic:
Recurrent implantation failure
Endometrial injury
Implantation
Hysteroscopy
Additional relevant MeSH terms:
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Infertility
Uterine Diseases
Genital Diseases, Male
Genital Diseases, Female