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

• Conditions: Polycystic Ovary Syndrome

• Registration Number: NCT02499289
• Lead Sponsor: Ain Shams University

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.

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 Timeline

• Study First Submitted: 2015-07-13
• Study First Submitted QC: 2015-07-14
• Study First Posted: 2015-07-16
• Study Start: 2015-10
• Status Verified: 2018-10
• Primary Completion: 2018-10
• Last Update Submitted: 2018-10-14
• Last Update Posted: 2018-10-16
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
plasma gherlin	one month	Plasma gherlin will be measured before and after 30 days fasting
clinical pregnancy	four months	We will record any pregnancy will happened in the next 4 months after Fasting without any ovulation induction.
plasma resistin	one month	Plasma resistin will be measured before and after 30 days fasting
Plasma adiponectin	one month	Plasma adiponectin will be measured before and after 30 days fasting

Trial Locations

Locations (1)

Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Al Qahirah, Egypt