Does Myomectomy for Intramural Fibroid Improve ART Outcome?

Fibroid Uterus Clinical Trial

— MIFART  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03796130
• Other study ID #: H0008
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: April 2021

Study information

• Verified date: November 2019
• Source: Mansoura University
• Contact: Eman ElGindy, MD, PhD
• Phone: 01227491143
• Email: eman_elgindy2013[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibroid Uterus
• Leiomyoma

Intervention

Procedure:
• Myomectomy
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

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura	Dakahlia

Sponsors (5)

Lead Sponsor	Collaborator
Mansoura University	Alexandria University, Assiut University, Sohag University, Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be ongoing pregnancy rate	Pregnancy continued after 12 week gestation per randomised women	3 months after embryo transfer
Secondary	-Implantation rate		15 days after embryo transfer
Secondary	-clinical pregnancy rate		5 weeks after embryo transfer