Does Myomectomy for Intramural Fibroid Improve ART Outcome?

Not Applicable

• Conditions: Fibroid Uterus
• Interventions: Procedure: Myomectomy

• Registration Number: NCT03796130
• Lead Sponsor: Mansoura University

Brief Summary

Intamural fibroids (myoma) do exist in some infertile women undergoing IVF treatment. There is controversy whether myomectomy before IVF treatment could improve IVF outcome. This trial will examine whether myomectomy in those patients could improve the results.

Detailed Description

This study will include women who have intramural myoma ranging from 3-5 cm

The participants will be randomly allocated into two groups.

In group (1): myomectomy will be performed before ART

In group (2):women will have their trial of ART without myomectomy

In group A, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery

Study Timeline

• Study First Submitted: 2019-01-04
• Study First Submitted QC: 2019-01-04
• Study First Posted: 2019-01-08
• Status Verified: 2019-11
• Study Start: 2019-12-01
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-16
• Primary Completion: 2021-04
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Inclusion criteria:
• Women with intramural fibroid without any cavity involvement
• Age ˂ 35 years
• I onCSI or IVF cycles
• normal uterine cavity

Exclusion Criteria

• Exclusion criteria:
• low ovarian reserve (AFC < 7 and or AMH < 1.1 ng/ml)
• Endometrioma
• Untreated hydrosalpinx
• Non obstructive azoospermia
• Any other cavitary lesions (Asherman syndrome, Mullerian anomalies)
• recurrent implantation failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(A)Myomectomy	Myomectomy	This study will include women who have intramural myomas ranging from 3-5 cm The participants will be randomlyallocated intotwo groups. In group (A): myomectomy will be performed before ART In group 1, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery

Primary Outcome Measures

Name	Time	Method
The primary outcome will be ongoing pregnancy rate	3 months after embryo transfer	Pregnancy continued after 12 week gestation per randomised women

Secondary Outcome Measures

Name	Time	Method
-Implantation rate	15 days after embryo transfer
-clinical pregnancy rate	5 weeks after embryo transfer

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt