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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02499289
• Other study ID #: PCOS FASTING
• Status: Active, not recruiting
• Start date: October 2015
• Est. completion date: November 2018

Study information

• Verified date: October 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: November 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Ain Shams University	Cairo	Al Qahirah

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	clinical pregnancy	We will record any pregnancy will happened in the next 4 months after Fasting without any ovulation induction.	four months
Secondary	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
Secondary	Plasma adiponectin	Plasma adiponectin will be measured before and after 30 days fasting	one month
Secondary	plasma resistin	Plasma resistin will be measured before and after 30 days fasting	one month
Secondary	plasma gherlin	Plasma gherlin will be measured before and after 30 days fasting	one month