The Value of Myomectomy in Women With Intramural Myoma Before IVF.

Study Overview
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Brief Summary
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Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention . The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts. On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH), , 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.

Detailed Description
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Women with intramural myoma not reaching the endometrial cavity will be randomized to either open myomectomy or no intervention .The participants will be assessed through full history-taking with special consideration to age and the duration, type, and cause of infertility. The medical examination included general, abdominal, and vaginal examinations. Finally, an ultrasonography examination was performed to check for the presence of three or more preantral follicles and to exclude ovarian cysts. On day 3 of a natural cycle, a baseline levels of FSH, luteinizing hormone (LH), , 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.

Official Title
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The Value of Myomectomy in Women With Intramural Myoma Before IVF. A Randomized Controlled Trial

Conditions
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IVF, Fibroid Uterus

Intervention / Treatment
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* Procedure: Open myomectomy
* Drug: Gonadotropins
* Drug: Human chorionic gonadotropin
* Procedure: Ovum pick up
* Procedure: Embryo transfer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • age younger than 40 years FSH) less than 10 IU/L serum prolactin level normal uterine cavity abnormality was excluded by hysteroscopy or hysterosalpingography Exclusion Criteria: abnormal endocrine function (e.g. abnormal thyroid or adrenal function) ovarian cysts, hydrosalpinx endometrial polyps male partner with azoospermia ICSI performed for preimplantation genetic diagnosis.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Myomectomy group<br>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 | Procedure: Open myomectomy<br>* laparotomy then enucleation of the myoma followed by closure of the myometrial cavity<br>Drug: Gonadotropins<br>* Gonadotropin stimulation of follicular growth<br>* Other names: Controlled Ovarian stimulation;Drug: Human chorionic gonadotropin<br>* HCG triggering of ovulation<br>* Other names: Ovulation triggering;Procedure: Ovum pick up<br>* 34 to 36 hours after HCG triggering<br>Procedure: Embryo transfer<br>* Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval<br>|
| Active Comparator: Conservative group<br>women with intramural myoma not reaching endometrial cavity will undergo ovarian stimulation for in vitro fertilization | Drug: Gonadotropins<br>* Gonadotropin stimulation of follicular growth<br>* Other names: Controlled Ovarian stimulation;Drug: Human chorionic gonadotropin<br>* HCG triggering of ovulation<br>* Other names: Ovulation triggering;Procedure: Ovum pick up<br>* 34 to 36 hours after HCG triggering<br>Procedure: Embryo transfer<br>* Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate | appearance of one or more intrauterine gestational sac by transvaginal ultrasound | 4 weeks after embryo transfer |