Clinical trial NCT05590104: Hysteroscopic Isthmocele Repair on IVF Outcome
Official title: Effect of Hysteroscopic Isthmocele Repair on IVF Outcome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reproductive Issues
Cesarean Section; Dehiscence
Intrauterine Disorder
Lead sponsor: HealthPlus Fertility Center
Sponsor class: OTHER
First posted: 2022-10-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Clinical pregnancy
timeFrame: at 7 weeks of gestation or beyond
Secondary outcomes:
measure: Rate of Complications following hysteroscopic CS scar repair
timeFrame: up to 6 weeks
measure: Rate of Need of aspiration of intrauterine fluid
timeFrame: During the preparation of embryo transfer. Through study completion, an average of 1 year
measure: Rate of Early pregnancy complications
timeFrame: 12 weeks gestation
measure: Rate of Caesarean section scar dehiscence or rupture
timeFrame: Within 40 weeks of pregnancy
measure: Rate of delivery of a living baby
timeFrame: Within 40 weeks of pregnancy
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Healthplus fertility center
state: UAE
city: Abu Dhabi
country: United Arab Emirates
facility: Healthplus fertility center
Study officials:
References: