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

• ClinicalTrials.gov Identifier: NCT03796130
• Recruitment Status: Unknown
• First Posted: January 8, 2019
• Last Update Posted: December 16, 2019
• Sponsor: Mansoura University
• Collaborators: Alexandria University; Zagazig University; Sohag University; Assiut University
• Information provided by (Responsible Party): Ahmed Gibreel, Mansoura University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Fibroid Uterus	Procedure: Myomectomy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Does Myomectomy for Intramural Fibroid Improve ART Outcome? A Randomized Controlled Trial
• Actual Study Start Date: December 1, 2019
• Estimated Primary Completion Date: April 2021
• Estimated Study Completion Date: April 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. The primary outcome will be ongoing pregnancy rate [ Time Frame: 3 months after embryo transfer ]
   Pregnancy continued after 12 week gestation per randomised women

Secondary Outcome Measures :

1. -Implantation rate [ Time Frame: 15 days after embryo transfer ]
2. -clinical pregnancy rate [ Time Frame: 5 weeks after embryo transfer ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Women
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Eman ElGindy, MD, PhD; 01227491143; eman_elgindy2013@hotmail.com

Locations

Egypt

Mansoura University Hospital; Recruiting

Mansoura, Dakahlia, Egypt, 35111

Sponsors and Collaborators

Mansoura University

Alexandria University

Zagazig University

Sohag University

Assiut University

Investigators

• Principal Investigator: Ahmed Gibreel, MD; Mansoura University
• Study Director: Mohamed S Abdelhafez, MD; Mansoura University
• 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 Chair: Hamed Yossef, MD; Mansoura University

More Information

• Responsible Party: Ahmed Gibreel, Assistant professor, Mansoura University
• ClinicalTrials.gov Identifier: NCT03796130
• Other Study ID Numbers: H0008
• First Posted: January 8, 2019
• Last Update Posted: December 16, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Leiomyoma; Myofibroma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Connective Tissue; Connective Tissue Diseases