NCT03904368

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Fibroid Uterus
• IVF

Interventions

Type	Name	Description
PROCEDURE	Open myomectomy	laparotomy then enucleation of the myoma followed by closure of the myometrial cavity
DRUG	Gonadotropins	Gonadotropin stimulation of follicular growth
DRUG	Human chorionic gonadotropin	HCG triggering of ovulation
PROCEDURE	Ovum pick up	34 to 36 hours after HCG triggering
PROCEDURE	Embryo transfer	Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2019-04-05
• Last updated: 2019-04-05

Locations

1 site across 1 country: Egypt