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Effects of Intramural Fibroids on IVF Outcome

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03904355
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

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.

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

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Effects of Intramural Fibroids That do Not Distort the Uterine Cavity on IVF Outcome
Actual Study Start Date :
May 1, 2019
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Fiboroid group

Women with intramural myoma no reaching the cavity

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

    • Drug: human chorionic gonadotropin
    HCG triggering of ovulation
    Other Names:
  • Triggering of ovulation

    • Procedure: Ovum pick up
    34 to 36 hours after oocyte retrieval

    Procedure: Embryo transfer
    Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval
    Active Comparator: Non fibroid group

    Women without myomas

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

    • Drug: human chorionic gonadotropin
    HCG triggering of ovulation
    Other Names:
  • Triggering of ovulation

    • Procedure: Ovum pick up
    34 to 36 hours after oocyte retrieval

    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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 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:
    NCT03904355
    Other Study ID Numbers:
    • 54
    First Posted:
    Apr 5, 2019
    Last Update Posted:
    Aug 31, 2021
    Last Verified:
    Aug 1, 2021
    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:
    Infertility
    Infertility, Female
    Chorionic Gonadotropin

    Study Results

    No Results Posted as of Aug 31, 2021