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

NCT ID: NCT02499289

Last Updated: 2018-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-11-30

Brief Summary

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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

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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.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed El Kotb Abdel Fattah

Dr. Ahmed Kotb

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed M kotb, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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PCOS FASTING

Identifier Type: -

Identifier Source: org_study_id

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