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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03904368
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
20
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Open myomectomy
  • Drug: Gonadotropins
  • Drug: Human chorionic gonadotropin
  • Procedure: Ovum pick up
  • Procedure: Embryo transfer
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Value of Myomectomy in Women With Intramural Myoma Before IVF. A Randomized Controlled Trial
Anticipated Study Start Date :
Apr 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Myomectomy group

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

Procedure: Open myomectomy
laparotomy then enucleation of the myoma followed by closure of the myometrial cavity

Drug: Gonadotropins
Gonadotropin stimulation of follicular growth
Other Names:
  • Controlled Ovarian stimulation

    • Drug: Human chorionic gonadotropin
    HCG triggering of ovulation
    Other Names:
  • Ovulation triggering

    • 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
    Active Comparator: Conservative group

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

    Drug: Gonadotropins
    Gonadotropin stimulation of follicular growth
    Other Names:
  • Controlled Ovarian stimulation

    • Drug: Human chorionic gonadotropin
    HCG triggering of ovulation
    Other Names:
  • Ovulation triggering

    • 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

    Outcome Measures

    Primary Outcome Measures

    1. clinical pregnancy rate [4 weeks after embryo transfer]

      appearance of one or more intrauterine gestational sac by transvaginal ultrasound

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kasr Alainy medical school Cairo Egypt 12151

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Ahmed Maged, MD, Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed M Maged, MD, Principal investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03904368
    Other Study ID Numbers:
    • 55
    First Posted:
    Apr 5, 2019
    Last Update Posted:
    Apr 5, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leiomyoma
    Myofibroma
    Chorionic Gonadotropin

    Study Results

    No Results Posted as of Apr 5, 2019