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

Not Applicable

• Conditions: Fibroid Uterus; IVF
• Interventions: Drug: Gonadotropins; Procedure: Open myomectomy; Drug: Human chorionic gonadotropin; Procedure: Ovum pick up; Procedure: Embryo transfer

• Registration Number: NCT03904368
• Lead Sponsor: Cairo University

Brief 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.

Study Timeline

• Study First Submitted: 2019-03-31
• Status Verified: 2019-04
• Study Start: 2019-04
• Study First Submitted QC: 2019-04-03
• Last Update Submitted: 2019-04-03
• Study First Posted: 2019-04-05
• Last Update Posted: 2019-04-05
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative group	Gonadotropins	women with intramural myoma not reaching endometrial cavity will undergo ovarian stimulation for in vitro fertilization
Myomectomy group	Embryo transfer	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
Myomectomy group	Open myomectomy	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
Myomectomy group	Gonadotropins	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
Myomectomy group	Ovum pick up	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
Conservative group	Ovum pick up	women with intramural myoma not reaching endometrial cavity will undergo ovarian stimulation for in vitro fertilization
Conservative group	Embryo transfer	women with intramural myoma not reaching endometrial cavity will undergo ovarian stimulation for in vitro fertilization
Myomectomy group	Human chorionic gonadotropin	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
Conservative group	Human chorionic gonadotropin	women with intramural myoma not reaching endometrial cavity will undergo ovarian stimulation for in vitro fertilization

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	4 weeks after embryo transfer	appearance of one or more intrauterine gestational sac by transvaginal ultrasound

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt