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

Cairo University (CU)

Status: Unknown

Conditions: IVF; Fibroid Uterus

Treatments: Procedure: Ovum pick up; Procedure: Embryo transfer; Drug: Human chorionic gonadotropin; Procedure: Open myomectomy; Drug: Gonadotropins

Study type: Interventional

Funder types: Other

Identifiers

NCT03904368

55

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Myomectomy group

Active Comparator group

Description:

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

Treatment:

Procedure: Open myomectomy

Drug: Gonadotropins

Procedure: Embryo transfer

Procedure: Ovum pick up

Drug: Human chorionic gonadotropin

Conservative group

Active Comparator group

Description:

women with intramural myoma not reaching endometrial cavity will undergo ovarian stimulation for in vitro fertilization

Treatment:

Drug: Gonadotropins

Procedure: Embryo transfer

Procedure: Ovum pick up

Drug: Human chorionic gonadotropin