Does Myomectomy for Intramural Fibroid Improve ART Outcome? (MIFART)

Mansoura University

Status: Unknown

Conditions: Fibroid Uterus

Treatments: Procedure: Myomectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03796130

H0008

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

(A)Myomectomy

Experimental group

Description:

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

Treatment:

Procedure: Myomectomy

(B) No myomectomy

No Intervention group

Description:

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