The Value of Myomectomy in Women With Intramural Myoma Before IVF.
NCT ID: NCT03904368
Last Updated: 2019-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2019-04-30
2020-12-31
Brief Summary
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, estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.
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Detailed Description
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, estradiol and anti-Müllerian hormone (AMH).Ovarian stimulation was performed using a long, antagonist, or short protocol. They were assigned to one of the 2 groups according to having an intramural myoma not indenting the cavity or not. All will be followed up by transvaginal ultrasonography . When two or more follicles had reached a mean diameter of 18 mm, oocyte maturation was triggered by intramuscular administration of hCG. Embryo transfer will be done at day 2, 3 or 5 according to the circumstances.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Myomectomy group
women with intramural myoma not reaching endometrial cavity will undergo open myomectomy followed by ovarian stimulation for in vitro fertilization 6 months after the operation
Open myomectomy
laparotomy then enucleation of the myoma followed by closure of the myometrial cavity
Gonadotropins
Gonadotropin stimulation of follicular growth
Human chorionic gonadotropin
HCG triggering of ovulation
Ovum pick up
34 to 36 hours after HCG triggering
Embryo transfer
Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval
Conservative group
women with intramural myoma not reaching endometrial cavity will undergo ovarian stimulation for in vitro fertilization
Gonadotropins
Gonadotropin stimulation of follicular growth
Human chorionic gonadotropin
HCG triggering of ovulation
Ovum pick up
34 to 36 hours after HCG triggering
Embryo transfer
Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval
Interventions
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Open myomectomy
laparotomy then enucleation of the myoma followed by closure of the myometrial cavity
Gonadotropins
Gonadotropin stimulation of follicular growth
Human chorionic gonadotropin
HCG triggering of ovulation
Ovum pick up
34 to 36 hours after HCG triggering
Embryo transfer
Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* FSH) less than 10 IU/L
* serum prolactin level normal
* uterine cavity abnormality was excluded by hysteroscopy or hysterosalpingography
Exclusion Criteria
* ovarian cysts,
* hydrosalpinx
* endometrial polyps
* male partner with azoospermia
* ICSI performed for preimplantation genetic diagnosis.
18 Years
40 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed M Maged, MD
Principal investigator
Principal Investigators
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Ahmed Maged, MD
Role: PRINCIPAL_INVESTIGATOR
Professor
Locations
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Kasr Alainy medical school
Cairo, , Egypt
Countries
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Central Contacts
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Other Identifiers
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55
Identifier Type: -
Identifier Source: org_study_id
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