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

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: Unknown
• Conditions: Polycystic Ovary Syndrome

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: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
spontaneous ovulation measured by midluteal progesterone	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

Outcome Measure	Measure Description	Time Frame
clinical pregnancy	We will record any pregnancy will happened in the next 4 months after Fasting without any ovulation induction.	four months
fasting glucose/insuline ratio	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	Plasma adiponectin will be measured before and after 30 days fasting	one month
plasma resistin	Plasma resistin will be measured before and after 30 days fasting	one month
plasma gherlin	Plasma gherlin will be measured before and after 30 days fasting	one month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): November 1, 2018

Study Registration Dates

• First Submitted: July 13, 2015
• First Submitted That Met QC Criteria: July 14, 2015
• First Posted (Estimate): July 16, 2015

Study Record Updates

• Last Update Posted (Actual): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 14, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: PCOS FASTING

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided