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

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

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.

Study Overview

• Status: Unknown
• Conditions: Fibroid Uterus
• Intervention / Treatment: Procedure: Myomectomy

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35111
      • Recruiting
      • Mansoura University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: (A)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	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
NO_INTERVENTION: (B) No 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 (B):women will have their trial of ART without myomectomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Collaborators: Zagazig University; Alexandria University; Assiut University; Sohag University
• Investigators: Study Director: Salah Rasheed, MD, Sohag University; Study Director: Ahmed Nasr, MD, Assiut Universit; Study Director: Hisham A Saleh, MD, Alexandria University; Study Director: Hassan El Maghraby, MD, Alexandria University; Study Chair: Eman El Gindy, MD, Zagazig University; Study Director: Hoda Sibai, MD, Zagazig University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ANTICIPATED): April 1, 2021
• Study Completion (ANTICIPATED): April 1, 2021

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: January 4, 2019
• First Posted (ACTUAL): January 8, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2019
• Last Update Submitted That Met QC Criteria: December 13, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: H0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No