Hysteroscopic Isthmocele Repair on IVF Outcome

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cesarean Section; Dehiscence; Reproductive Issues; Intrauterine Disorder
• Intervention / Treatment: Procedure: Hysteroscopic CS scar defect repair

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Recruiting
    • HealthPlus Fertility Center
    • Contact: Ahmed Elbohoty, PHD; Phone Number: 00971504067530; Email: elbohoty79@gmail.com
  • UAE
    • Abu Dhabi, UAE, United Arab Emirates, 11231
      • Recruiting
      • HealthPlus Fertility Center
      • Contact: Ahmed Elbohoty; Phone Number: 00971504067530; Email: elbohoty79@gmail.com
      • Contact: Phone Number: 600503535

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hysteroscopic CS scar defect repair; 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; 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.
No Intervention: Expectant management; Patient who is randomized to the expectant management will be prepared for another embryo transfer for euoploid embryo.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: HealthPlus Fertility Center

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2023
• Primary Completion (Anticipated): May 30, 2024
• Study Completion (Anticipated): May 30, 2024

Study Registration Dates

• First Submitted: October 12, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 29, 2023
• Last Update Submitted That Met QC Criteria: March 26, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HIROIO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This prospective randomized controlled 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. Secondary 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.
• IPD Sharing Time Frame: 18 months
• IPD Sharing Access Criteria: open
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No