NCT03796130

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

December 16, 2019

Status Verified

November 1, 2019

Enrollment Period

1.3 years

First QC Date

January 4, 2019

Last Update Submit

December 13, 2019

Conditions

Fibroid Uterus

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will be ongoing pregnancy rate

    Pregnancy continued after 12 week gestation per randomised women

    3 months after embryo transfer

Secondary Outcomes (2)

  • -Implantation rate

    15 days after embryo transfer

  • -clinical pregnancy rate

    5 weeks after embryo transfer

Study Arms (2)

(A)Myomectomy

EXPERIMENTAL

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

(B) No myomectomy

NO INTERVENTION

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

Interventions

MyomectomyPROCEDURE

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

(A)Myomectomy

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women with intramural fibroid without any cavity involvement
  • Age ˂ 35 years
  • I onCSI or IVF cycles
  • normal uterine cavity

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35111, Egypt

RECRUITING

MeSH Terms

Conditions

Leiomyoma

Interventions

Uterine Myomectomy

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Ahmed Gibreel, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

  • Eman El Gindy, MD

    Zagazig University

    STUDY CHAIR

  • Hoda Sibai, MD

    Zagazig University

    STUDY DIRECTOR

  • Hamed Yossef, MD

    Mansoura University

    STUDY CHAIR

Central Study Contacts

Eman ElGindy, MD, PhD

CONTACT

01227491143eman_elgindy2013@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 4, 2019

First Posted

January 8, 2019

Study Start

December 1, 2019

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

December 16, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

Locations

EG(1)