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

NCT03904368 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-04-05

No results posted yet for this study

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.

Conditions

  • Fibroid Uterus
  • IVF

Interventions

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed Maged, MD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03904368 on ClinicalTrials.gov