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Predictors of Ovarian Reserve in Infertile Women

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02896023
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
42
Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients will be subjected to:
  1. Clinical evaluation including history and examination
B. Ultrasonographic evaluation of Ovarian Morphometry:

  • Patients will be evaluated in early follicular phase of the menstrual flow (cycle's days 1-3) by TVS scanning; using MINDRAY DP-1100 Plus Digital Machine, 7.5MHz, China, by only one examiner to avoid inter-observer variations.

  • Ovarian images will be procured in the sagittal and coronal planes and the frozen image reflecting the largest ovarian dimensions will be utilized for the measurement of ovarian length, width, and height (cm) as per standard clinical practice. Mean values of both ovaries will be used. Ovarian volume will be calculated from ellipsoid volume formula, {Ovarian volume = Ovarian Width (D1) × Ovarian Length (D2) ×Ovarian Height (D3) × 0 .523}

  • Antral follicle count will be determined for each patient

C. Laboratory Evaluation:

Blood samples will be collected in the early follicular phase. Samples will be immediately centrifuged and serum saved at -20 degrees for measurement of:

  • Anti Mullerian Hormone (AMH)

  • Follicle Stimulating Hormone (FSH)

  • Estradiol (E2) Using electro-chemiluminescence immunoassay (ELICA)

Condition or Disease Intervention/Treatment Phase
  • Drug: human menopausal gonadotropin
 Phase 4

Detailed Description

Patients will be subjected to:
  1. Clinical evaluation including history and examination
B. Ultrasonographic evaluation of Ovarian Morphometry:

  • Patients will be evaluated in early follicular phase of the menstrual flow (cycle's days 1-3) by TVS scanning; using MINDRAY DP-1100 Plus Digital Machine, 7.5MHz, China, by only one examiner to avoid inter-observer variations.

  • Ovarian images will be procured in the sagittal and coronal planes and the frozen image reflecting the largest ovarian dimensions will be utilized for the measurement of ovarian length, width, and height (cm) as per standard clinical practice. Mean values of both ovaries will be used. Ovarian volume will be calculated from ellipsoid volume formula, {Ovarian volume = Ovarian Width (D1) × Ovarian Length (D2) ×Ovarian Height (D3) × 0 .523}

  • Antral follicle count will be determined for each patient

C. Laboratory Evaluation:

Blood samples will be collected in the early follicular phase. Samples will be immediately centrifuged and serum saved at -20 degrees for measurement of:

  • Anti Mullerian Hormone (AMH)

  • Follicle Stimulating Hormone (FSH)

  • Estradiol (E2) Using electro-chemiluminescence immunoassay (ELICA)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
Sonographic and Laboratory Predictors of Ovarian Reserve in Infertile Women
Study Start Date :
Sep 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
Mar 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: pregnant

women with positive pregnancy test after induction of ovulation and ICSI

Drug: human menopausal gonadotropin
Induction of ovulation followed by ICSI
Other Names:
  • menogon

    		•
    Active Comparator: Not pregnant

    women with negative pregnancy test after induction of ovulation and ICSI

    Drug: human menopausal gonadotropin
    Induction of ovulation followed by ICSI
    Other Names:
  • menogon

    		•

    Outcome Measures

    Primary Outcome Measures

    1. positive pregnancy test [14 days after embryo transfer]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 39 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • less than 39 years old,

    • normal menstrual cycle with a range of 24 to 35 days

    • normal seum prolactin.

    • normal uterine cavity determined by previous hysterosalpingography or hysteroscopy

    Exclusion Criteria:

    • smokers

    • endometriosis

    • Women with endometriosis;

    • abnormal endocrine functions such as diabetes mellitus, thyroid disorders, and adrenal abnormalities; general diseases, those with ovarian cysts, or those who have azospermia partners.

    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, Kasr Alainy medical school

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed M Maged, MD, Assistant professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT02896023
    Other Study ID Numbers:
    • 154
    First Posted:
    Sep 12, 2016
    Last Update Posted:
    Sep 23, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Ahmed M Maged, MD, Assistant professor, Cairo University
    predictors
    ovarian reserve
    infertile women
    Additional relevant MeSH terms:
    Infertility
    Menotropins

    Study Results

    No Results Posted as of Sep 23, 2019