Does Myomectomy for Intramural Fibroid Improve ART Outcome?

Study Overview
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Brief Summary
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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
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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

Official Title
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Does Myomectomy for Intramural Fibroid Improve ART Outcome? A Randomized Controlled Trial

Conditions
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Fibroid Uterus

Intervention / Treatment
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* Procedure: Myomectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (A)Myomectomy<br>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 | Procedure: Myomectomy<br>* This study will include women who have intramural myomas 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<br>|
| No Intervention: (B) No myomectomy<br>This study will include women who have intramural myomas ranging from 3-5 cm The participants will be randomly allocated into two groups. In group (B):women will have their trial of ART without myomectomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome will be ongoing pregnancy rate | Pregnancy continued after 12 week gestation per randomised women | 3 months after embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -Implantation rate |  | 15 days after embryo transfer | 
| -clinical pregnancy rate |  | 5 weeks after embryo transfer |