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

Primary Purpose

Fibroid Uterus

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Myomectomy

About this trial

This is an interventional treatment trial for Fibroid Uterus

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept 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

Sites / Locations

Mansoura University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

(A)Myomectomy

(B) No myomectomy

Arm 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

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

Outcomes

Primary Outcome Measures

The primary outcome will be ongoing pregnancy rate

Pregnancy continued after 12 week gestation per randomised women

Secondary Outcome Measures

-Implantation rate

-clinical pregnancy rate

Full Information

NCT ID

NCT03796130

First Posted

January 4, 2019

Last Updated

December 13, 2019

Sponsor

Mansoura University

Collaborators

Alexandria University, Zagazig University, Sohag University, Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT03796130

Brief Title

Does Myomectomy for Intramural Fibroid Improve ART Outcome?

Acronym

MIFART

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 1, 2019 (Actual)

Primary Completion Date

April 2021 (Anticipated)

Study Completion Date

April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

Collaborators

Alexandria University, Zagazig University, Sohag University, Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibroid Uterus

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

(A)Myomectomy

Arm Type

Experimental

Arm Description

Arm Title

(B) No myomectomy

Arm Type

No Intervention

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Myomectomy

Intervention 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 (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

Primary Outcome Measure Information:

Title

The primary outcome will be ongoing pregnancy rate

Description

Pregnancy continued after 12 week gestation per randomised women

Time Frame

3 months after embryo transfer

Secondary Outcome Measure Information:

Title

-Implantation rate

Time Frame

15 days after embryo transfer

Title

-clinical pregnancy rate

Time Frame

5 weeks after embryo transfer

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Women

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eman ElGindy, MD, PhD

Phone

01227491143

eman_elgindy2013@hotmail.com

Overall Study Officials: