Fibroid Uterus Clinical Trial
— MIFARTOfficial title:
Does Myomectomy for Intramural Fibroid Improve ART Outcome? A Randomized Controlled Trial
NCT number | NCT03796130 |
Other study ID # | H0008 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | December 1, 2019 |
Est. completion date | April 2021 |
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | April 2021 |
Est. primary completion date | April 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Mansoura University Hospital | Mansoura | Dakahlia |
Lead Sponsor | Collaborator |
---|---|
Mansoura University | Alexandria University, Assiut University, Sohag University, Zagazig University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome will be ongoing pregnancy rate | Pregnancy continued after 12 week gestation per randomised women | 3 months after embryo transfer | |
Secondary | -Implantation rate | 15 days after embryo transfer | ||
Secondary | -clinical pregnancy rate | 5 weeks after embryo transfer |
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