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Effect of Vitamin D Status on Clinical Pregnancy Rates Following Intra Cytoplasmic Sperm Injection

Sponsor
Ain Shams Maternity Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02987478
Collaborator
(none)
240
Enrollment
1
Location
21
Duration (Months)
11.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

All patients will undergo in vitro fertilization.

Serum 25 (OH) D samples will be collected within1 week before oocyte retrieval.

Whole blood specimens will be collected in serum separator tubes using acceptable medical techniques to avoid hemolysis.

Ultrasound guided fresh embryo transfer will be performed on day 5 after fertilization.

clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound performed 4-5 weeks after embryo transfer.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    PATIENTS AND METHODS

    Protocol Outline:
    The Study:
    Study site:

    Ain Shams University Maternity Hospital.

    Study Design:

    A prospective Cohort study.

    Study setting:

    The study will be conducted at Ain Shams University Maternity Hospital.

    Study population:

    The study will include all women planned to undergo IVF due to unexplained infertility.

    Methodology:

    The study will be approved by the hospital ethics committee.

    All included women will undergo the following:

    • History taking.

    • General and abdominal examination.

    • Vaginal examination and assessment

    • Pelvic ultrasound.

    • Routine laboratory investigations including complete blood picture, hematocrit, liver and kidney function tests and coagulation profile.

    • Preoperative senior anesthetist assessment.

    • Hysteroscopy.

    All patients will undergo IVF.

    Serum 25(OH)D samples will be collected within1 week before oocyte retrieval.

    Whole blood specimens will be collected in serum separator tubes using acceptable medical techniques to avoid hemolysis.

    Ultrasound-guided fresh embryo transfer will be performed on day 5 after fertilization.

    clinical pregnancy will be confirmed by observation of intrauterine sac visible on ultrasound performed 4-5 weeks after embryo transfer.

    Measurement of Outcomes

    1. serum 25 (OH) D levels.

    2. Number of oocyte.

    Most studies put the optimal number of retrieved oocytes between 10 and 15.

    1. The implantation rate:

    Calculated as the number of gestational sacs observed by ultrasound divided by the number of embryos transferred, multiplied by 100.

    1. Number of gestational sac.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    240 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effect of Vitamin D Status on Clinical Pregnancy Rates Following Intra Cytoplasmic Sperm Injection
    Study Start Date :
    Mar 1, 2016
    Anticipated Primary Completion Date :
    Mar 1, 2017
    Anticipated Study Completion Date :
    Dec 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. pregnancy [4-5 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Age between 20 and 35 years old.

    • Body mass index between 20 - 30.

    • Unexplained infertility .

    • Follicle-stimulating hormone level 12 IU/L or lower (baseline level, cycle day 3).

    • Normal hysteroscopy ( healthy uterus with no fibroids or other growths)

    • Fresh embryo transfer of 2 or more blastocysts stage.

    • Embryo transfer on day 5 after fertilization

    Exclusion Criteria:

    • Women younger than 20 years old or older than 35 years old.

    • Previous one or more failed IVF.

    • Uncorrected congenital or acquired uterine anomalies.

    • Other causes of infertility rather than unexplained infertility.

    • Less than 2 embryo transfer, cleavage stager frozen embryo transfer.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ain Shams University Maternity Hospital Cairo Abbassia Egypt 11566

    Sponsors and Collaborators

    • Ain Shams Maternity Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alaa Sayed Abdul-hafeez, Clinical Professor, Ain Shams Maternity Hospital
    ClinicalTrials.gov Identifier:
    NCT02987478
    Other Study ID Numbers:
    • 6789
    First Posted:
    Dec 9, 2016
    Last Update Posted:
    Dec 9, 2016
    Last Verified:
    Dec 1, 2016
    Keywords provided by Alaa Sayed Abdul-hafeez, Clinical Professor, Ain Shams Maternity Hospital
    Vitamin D following intra cytoplasmic sperm injection
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Dec 9, 2016