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Effect of Ramadan Fasting on Ovulation and Insuline Resistance in Patients With PCOS

Sponsor
Ain Shams University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02499289
Collaborator
(none)
80
Enrollment
1
Location
37
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Polycystic ovary syndrome (PCOS) has a heterogeneous clinical presentation comprising reproductive (hyperandrogenism, menstrual irregularity, anovulation, infertility, pregnancy complications), metabolic [insulin resistance (IR), increased type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD) risk factors] and psychological features (worsened quality of life and increased anxiety and depression) Whether prolonged fasting during Ramadan breaks the insulin resistance state of polycystic ovarian syndrome and subsequently improve the ovulation and spontaneous pregnancy will happen without ovarian stimulation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Question of the study:

    The question is raised whether prolonged fasting during Ramadan breaks the insulin resistance state of polycystic ovarian syndrome and improve the metabolic syndrome does prolonged fasting decrease glucose level, insulin level, insulin resistance markers such as adipokines and subsequently improve ovarian function and causes spontaneous ovulation.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Does Prolonged Fasting Break the Vicious Circle of Polycystic Ovarian Syndrome of Insulin Resistance ?
    Actual Study Start Date :
    Oct 1, 2015
    Anticipated Primary Completion Date :
    Oct 1, 2018
    Anticipated Study Completion Date :
    Nov 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. spontaneous ovulation measured by midluteal progesterone [one month]

      Ovulation will be monitored by the Progesterone level on 22nd day of first cycle after 30 days of prolonged daily Fasting (Ramadan).

    Secondary Outcome Measures

    1. clinical pregnancy [four months]

      We will record any pregnancy will happened in the next 4 months after Fasting without any ovulation induction.

    2. fasting glucose/insuline ratio [one month]

      Insulin resistance (IR) measuring: fasting 8 hours. Plasma glucose (FPG) and fasting insulin (FIN) will be measured by chemiluminescent immunoassay. The ratio of glucose/insulin represents the degree of IR

    3. Plasma adiponectin [one month]

      Plasma adiponectin will be measured before and after 30 days fasting

    4. plasma resistin [one month]

      Plasma resistin will be measured before and after 30 days fasting

    5. plasma gherlin [one month]

      Plasma gherlin will be measured before and after 30 days fasting

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Females with PCO in child bearing age who presented at reproductive and endocrinology clinics at Ain Shams University Maternity Hospital, and welling to fast for 30 days from 5 am until 7 pm and do not plan to induce her ovulation in the next 4 months to get pregnant.

    • Does not have any other medical illnesses other than PCO.

    • Welling not to start any ovulation induction in the next 4 months after the first blood sample was taken and after fasting month.

    Exclusion Criteria:

    • Known androgen secreting tumor.

    • PCO on ovarian stimulation medications

    • PCO with any other medical illness.

    • Non-compliance with fasting 30 days from 5 am- 7 pm.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine, Ain Shams University Cairo Al Qahirah Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    • Principal Investigator: Ahmed M kotb, MD, Ain Shams University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Mohamed El Kotb Abdel Fattah, Dr. Ahmed Kotb, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT02499289
    Other Study ID Numbers:
    • PCOS FASTING
    First Posted:
    Jul 16, 2015
    Last Update Posted:
    Oct 16, 2018
    Last Verified:
    Oct 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Syndrome

    Study Results

    No Results Posted as of Oct 16, 2018