Accuracy of Ultrasound Markers Versus Biochemical Markers in Prediction of Ovarian Response in Obese Women Undergoing IVF/ICSI Treatment

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03684824
Collaborator
(none)
100
1
1
13
7.7

Study Details

Study Description

Brief Summary

After detailed history and examination, long luteal protocol will be used for controlled ovarian hyperstimulation, so the patient will start treatment in day 21 of previous cycle, then in the early follicular phase of next cycle day 2-3 will have transvaginal sonography for assessment of total ovarian volume and number of antral follicles measuring (2-10mm) in diameter. On the same day a venous sample will be obtained for the measurement of AMH, basal FSH and E2 levels

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

After detailed history and examination,A transvaginal ultrasound will be done using a transvaginal transducer with 7.5 MHz.

Each ovary will be measured in 3 planes maximal longitudinal, antero-posterior and transverse diameters, D1, D2 and D3 respectively. And ovarian volume will be calculated using the ellipsoid formula:

V = D1× D2 × D3 × 0.523 The volume of both ovaries will be added for the total basal ovarian volume (BOV).

The mean diameter of the antral follicles will be used by measuring the diameter of the follicle in two perpendicular directions.

The total AFC is calculated by counting the follicles with mean diameter 2-10mm in both ovaries.

• Ovulation induction protocol:- Long luteal phase agonist protocol will be used in all patients. Pituitary suppression will be done using daily subcutaneous injection of triptorelin acetate ( Decapeptyl 0.1mg, Ferring, Germany). Starting from day 21 of the previous cycle.

Controlled ovarian hyperstimulation will be done using daily intramuscular injection of highly purified Human Menopausal Gonadotrophins (Merional 75 IU/ml, IBSA, Switzerland), starting from day 2-3 of the stimulated cycle, total dose will be adjusted according to patient response.

Induction of oocyte maturation will be done using human chorionic gonadotrophins as an intramuscular injection of 10000 IU hCG (Choriomon 5000 i.u, IBSA, Switzerland). When there was sufficient ovarian response that defined as the presence of three or more ovarian follicles with mean diameter 18mm or more. [15]

• Monitoring of the cycle: The response to ovarian stimulation will be monitored by serial transvaginal ultrasound starting on day 6 of stimulation and onwards assessing the ovarian follicles number and diameter, as well as serum E2 level as indicated.

• Oocyte Retriveal: Oocyte retrieval will done (34-36 hours) after hCG injection, by transvaginal guided vacuumed oocyte aspiration using double lumen oocyte aspiration needle for flushing of the follicles.

• Measurement of FSH and E2 Levels: A blood sample will be withdrawn on day (2 - 3) of the menstrual cycle in which the patient will undergo stimulation, for estimation the basal FSH (mIU/ml) , E2 (pg/ml) and AMH (ng/ml) levels.

Both FSH and E2 will be tested using VIDAS equipment, both the FSH and E2 were measured by automated quantitative testing, using the ELFA technique (Enzyme Linked Fluorescent Assay). In the same way, AMH will be tested by Beckman Coulter, using GenII ELISA, USA.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Accuracy of Ultrasound Markers Versus Biochemical Markers in Prediction of Ovarian Response in Obese Women Undergoing IVF/ICSI Treatment
Anticipated Study Start Date :
Sep 1, 2018
Anticipated Primary Completion Date :
Sep 1, 2019
Anticipated Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: obese group

100 obese patients with BMI between 30 and 35 who are undergoing IVF/ICSI treatment for infertility

Drug: Long luteal phase GnRH agonist protocol
Pituitary suppression will be done using daily subcutaneous injection of triptorelin acetate ( Decapeptyl 0.1mg, Ferring, Germany). Starting from day 21 of the previous cycle
Other Names:
  • Decapeptyl 0.1mg amp
  • Drug: Gonadotropins
    Controlled ovarian hyperstimulation will be done using daily intramuscular injection of highly purified Human Menopausal Gonadotrophins (Merional 75 IU/ml, IBSA, Switzerland), starting from day 2-3 of the stimulated cycle, total dose will be adjusted according to patient response
    Other Names:
  • Merional 75 IU/ml, IBSA, Switzerland
  • Outcome Measures

    Primary Outcome Measures

    1. number of retrieved oocytes [34 hours after HCG triggering of ovulation]

      number of oocytes retrieved at day of ovum pick up

    Secondary Outcome Measures

    1. Clinical pregnancy rate [14 days after embryo transfer]

      Ultrasound detection of intrauterine gestational sac

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Women between 20 and 35 age.

    • BMI: 30 -35

    Exclusion Criteria:
    • Women less than 19 years or more than 35 years.

    • BMI less than 30 or more than 35

    • Women with Hypothyroidism.

    • Women receiving any treatment may reduce their fertility e.g: chemotherapy.

    • Women with recurrent IVF failure

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ameer Elsherief Minya Egypt

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Ahmed maged, Professor

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Maged, professor, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03684824
    Other Study ID Numbers:
    • 39
    First Posted:
    Sep 26, 2018
    Last Update Posted:
    Sep 26, 2018
    Last Verified:
    Sep 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 26, 2018