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

October 14, 2018 updated by: Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University

Does Prolonged Fasting Break the Vicious Circle of Polycystic Ovarian Syndrome of Insulin Resistance ?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Al Qahirah
      • Cairo, Al Qahirah, Egypt
        • Faculty of Medicine, Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

• 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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
spontaneous ovulation measured by midluteal progesterone
Time Frame: one month
Ovulation will be monitored by the Progesterone level on 22nd day of first cycle after 30 days of prolonged daily Fasting (Ramadan).
one month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
clinical pregnancy
Time Frame: four months
We will record any pregnancy will happened in the next 4 months after Fasting without any ovulation induction.
four months
fasting glucose/insuline ratio
Time Frame: 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
one month
Plasma adiponectin
Time Frame: one month
Plasma adiponectin will be measured before and after 30 days fasting
one month
plasma resistin
Time Frame: one month
Plasma resistin will be measured before and after 30 days fasting
one month
plasma gherlin
Time Frame: one month
Plasma gherlin will be measured before and after 30 days fasting
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ahmed M kotb, MD, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PCOS FASTING

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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