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MIFART: Does Myomectomy for Intramural Fibroid Improve ART Outcome?

Sponsor
Mansoura University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03796130
Collaborator
Alexandria University (Other), Zagazig University (Other), Sohag University (Other), Assiut University (Other)
80
Enrollment
1
Location
2
Arms
16
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

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
  • Procedure: Myomectomy
 N/A

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
Anticipated 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 :
Dec 1, 2019
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
Apr 1, 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 [3 months after embryo transfer]

    Pregnancy continued after 12 week gestation per randomised women

Secondary Outcome Measures

  1. -Implantation rate [15 days after embryo transfer]

  2. -clinical pregnancy rate [5 weeks after embryo transfer]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Mansoura University Hospital 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Gibreel, Assistant professor, Mansoura University
ClinicalTrials.gov Identifier:
NCT03796130
Other Study ID Numbers:
  • H0008
First Posted:
Jan 8, 2019
Last Update Posted:
Dec 16, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
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

Study Results

No Results Posted as of Dec 16, 2019