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Effects of Intramural Fibroids on IVF Outcome

Not Applicable
Conditions
Infertility, Female
Assisted Reproduction
Interventions
Drug: Gonadotropins
Procedure: Ovum pick up
Procedure: Embryo transfer
Registration Number
NCT03904355
Lead Sponsor
Cairo University
Brief Summary

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.

Detailed 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
200
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
GroupInterventionDescription
Fiboroid groupGonadotropinsWomen with intramural myoma no reaching the cavity
Fiboroid groupOvum pick upWomen with intramural myoma no reaching the cavity
Fiboroid groupEmbryo transferWomen with intramural myoma no reaching the cavity
Non fibroid groupGonadotropinsWomen without myomas
Non fibroid groupOvum pick upWomen without myomas
Non fibroid groupEmbryo transferWomen without myomas
Fiboroid grouphuman chorionic gonadotropinWomen with intramural myoma no reaching the cavity
Non fibroid grouphuman chorionic gonadotropinWomen without myomas
Primary Outcome Measures
NameTimeMethod
clinical pregnancy rate4 weeks after embryo transfer

appearance of one or more intrauterine gestational sac

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Kasr Alainy medical school

🇪🇬

Cairo, Egypt

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