Effects of Intramural Fibroids on IVF Outcome

Cairo University (CU)

Status: Unknown

Conditions: Assisted Reproduction; Infertility, Female

Treatments: Procedure: Embryo transfer; Procedure: Ovum pick up; Drug: Gonadotropins; Drug: human chorionic gonadotropin

Study type: Interventional

Funder types: Other

Identifiers

NCT03904355

54

Details and patient eligibility

About

A cohort study involving 200 women candidate for IVF / ICSI cycles . 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

A cohort study involving 200 women candidate for IVF / ICSI cycles . 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: 200 estimated patients

Sex: Female

Ages: 20 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: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Fiboroid group

Active Comparator group

Description:

Women with intramural myoma no reaching the cavity

Treatment:

Procedure: Embryo transfer

Procedure: Ovum pick up

Drug: human chorionic gonadotropin

Drug: Gonadotropins

Non fibroid group

Active Comparator group

Description:

Women without myomas

Treatment:

Procedure: Embryo transfer

Procedure: Ovum pick up

Drug: human chorionic gonadotropin

Drug: Gonadotropins