Hysteroscopic Isthmocele Repair on IVF Outcome

Study Overview
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Brief Summary
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Hysteroscopic Isthmocele repair on IVF outcome It aims to assesse the efficacy of Hysteroscopic CS scar defect repair on the clinical pregnancy rate after embryo transfer. Patients who were diagnosed with significant caesarean section scar defect and had a previous unsuccessful ongoing pregnancy after embryo transfer of one or more euploid embryo and planning for another trial of one euploid embryo transfer will be assed for study eligibility. Twenty five of them will be be randomized to hysteroscopic repair before having embryo transfer. and 25 will go directly for embryo transfer. Clinical pregnancy rate is the primary outcome.

Detailed Description
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Hysteroscopic Isthmocele repair on IVF outcome Background: Uterine niche is a very common finding in women with previous caesarean section. Subfertility can be associated finding and IVF outcome can be affected by its presence. It is not yet if its treatment before IVF trial could improve the outcome of IVF cycle. Objectives: assesse the efficacy of Hysteroscopic CS scar defect repair on the clinical pregnancy rate after embryo transfer. Methods This prospective randomized controled will be conducted at Healthplus fertility center. The population of the study will be Patients who was diagnosed with significant caesarean section scar defect and had a previous unsuccessful ongoing pregnancy after embryo transfer of one or more euploid embryo and planning for another trial of one euploid embryo transfer. Twenty five of them will be be randomized to hysteroscopic repair before having embryo transfer. and 25 will go directly for embryo transfer. Clinical pregnancy rate is the primary outcome. Seconday outcomes are Complications following hysteroscopic CS scar repair, the need of aspiration of intrauterine fluid before embryo transfer, early pregnancy complications, Caesarean section scar dehiscence or rupture and live birth rate.

Official Title
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Effect of Hysteroscopic Isthmocele Repair on IVF Outcome: A Randomized Controlled Trial

Conditions
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Reproductive Issues, Cesarean Section; Dehiscence, Intrauterine Disorder

Intervention / Treatment
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* Procedure: Hysteroscopic CS scar defect repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed CS scar defect by TVUS At least one failed trial of euploid embryo transfer Planning for a trial of single euploid embryo transfer Exclusion Criteria: Residual myometrial thickness less than 3 mm Any congenital uterine abnormalities., Prescence of intrauterine lesions e.g. polyp, fibroid, Endometriosis or adenomyosis, Hydrosalpinx, Chronic endometritis, Previous CS scar defect repair.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hysteroscopic CS scar defect repair<br>Patient who is randomized to the hysteroscopic repair of CS scar defect will be prepared to have the surgery postmenstrual. The surgery will be under general anasthesia. The participants will be placed in the lithotomy position. The cervix will be visualized using a Sims speculum and grasped using a single-toothed tenaculum, and the cervix, fornix, and vagina will be cleaned. Dilatation of the cervix till 7 mm. Introduce the resctoscope through the cervix. The surgical correction of the isthmocele is done by resection of the inferior and superior edges or just the inferior edge of the defect with a resectoscopic loop, using pure cutting current, until reaching the muscular layer. Coagulation of fragile vessels at the base or even entire niche. At the end of procedure, flow and pressure of distending medium can be reduced to ensure adequate haemostasis. After that the patient will be prepared for another euoploid embryo transfer. | Procedure: Hysteroscopic CS scar defect repair<br>* Dilatation of the cervix till 7 mm. Introduce the resctoscope through the cervix. The surgical correction of the isthmocele is done by resection of the inferior and superior edges or just the inferior edge of the defect with a resectoscopic loop, using pure cutting current, until reaching the muscular layer. Coagulation of fragile vessels at the base or even entire niche. At the end of procedure, flow and pressure of distending medium can be reduced to ensure adequate haemostasis.<br>|
| No Intervention: Expectant management<br>Patient who is randomized to the expectant management will be prepared for another embryo transfer for euoploid embryo. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Clinical pregnancy | detection of intrauterine pregnancy with a detectable fetal heart pulsation by transvaginal ultrasound scan | at 7 weeks of gestation or beyond | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Complications following hysteroscopic CS scar repair | uterine perforation, fluid overload and endometritis | up to 6 weeks | 
| Rate of Need of aspiration of intrauterine fluid | Presence intrauterine fluid collection at the time of embryo transfer which should be aspirated before embryo transfer | During the preparation of embryo transfer. Through study completion, an average of 1 year | 
| Rate of Early pregnancy complications | Ectopic pregnancy or Miscarriage | 12 weeks gestation | 
| Rate of Caesarean section scar dehiscence or rupture | Rupture of CS scar during the antenatal period or presence of CS scar wound dehiscence at the time of delivery | Within 40 weeks of pregnancy | 
| Rate of delivery of a living baby | Delivery of a living baby after 24 weeks gestation | Within 40 weeks of pregnancy |