Hysteroscopic Isthmocele Repair on IVF Outcome

Not Applicable

Recruiting

• Conditions: Cesarean Section; Dehiscence; Reproductive Issues; Intrauterine Disorder

• Registration Number: NCT05590104
• Lead Sponsor: HealthPlus Fertility Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-21
• Status Verified: 2023-03
• Study Start: 2023-03-26
• Last Update Submitted: 2023-03-26
• Last Update Posted: 2023-03-29
• Primary Completion: 2024-05-30
• Study Completion: 2024-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Rate of Clinical pregnancy	at 7 weeks of gestation or beyond	detection of intrauterine pregnancy with a detectable fetal heart pulsation by transvaginal ultrasound scan

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Healthplus fertility center; 🇦🇪 Abu Dhabi, United Arab Emirates