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The aim of this study is to investigate that the efficacy of the endometrial injury before IVF in recurrent implantation failure patients.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injury group | Experimental | Endometrial injury with hysteroscopy |
|
| Control group | No Intervention | No hysteroscopy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Pregnancy | Blood concentration of beta-hcg | 1month |
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Inclusion Criteria:
Exclusion Criteria:
Only women with recurrent implantation failure
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Timur Gurgan, MD,Professor | Contact | 0905322317706 | tgurgan@gurganclinic.com.tr | |
| Muberra Namlı Kalem, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Ziya Kalem, MD | Gurgan Clinic IVF and Women Health Center | Principal Investigator |
| Halil Ruso, Embryologist | GurganClinic IVF and Women Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gurgan Clinic IVF and Women Health Center | Recruiting | Ankara | Cankaya | 06640 | Turkey (Türkiye) |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 19, 2019 | |
| Reset | Apr 25, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 19, 2019 | Apr 25, 2019 |
| ID | Term |
|---|---|
| D007246 | Infertility |
| D014591 | Uterine Diseases |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D015907 | Hysteroscopy |
| ID | Term |
|---|---|
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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|
| Antonis Makrigiannakis, MD,Professor |
| Greek University |
| Principal Investigator |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013513 | Obstetric Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |