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Does Myomectomy for Intramural Fibroid Improve ART Outcome?

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03796130
Acronym
MIFART
Enrollment
80
Registered
2019-01-08
Start date
2019-12-01
Completion date
2021-04-30
Last updated
2019-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibroid Uterus

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

Interventions

PROCEDUREMyomectomy

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

Sponsors

Alexandria University
CollaboratorOTHER
Zagazig University
CollaboratorOTHER_GOV
Sohag University
CollaboratorOTHER
Assiut University
CollaboratorOTHER
Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
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

*

Design outcomes

Primary

MeasureTime frameDescription
The primary outcome will be ongoing pregnancy rate3 months after embryo transferPregnancy continued after 12 week gestation per randomised women

Secondary

MeasureTime frame
-Implantation rate15 days after embryo transfer
-clinical pregnancy rate5 weeks after embryo transfer

Countries

Egypt

Contacts

Primary ContactEman ElGindy, MD, PhD
eman_elgindy2013@hotmail.com01227491143

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026