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

NCT02499289 | Unknown DMC

• 1 other identifier: PCOS FASTING
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• clinical pregnancy

  four months

• fasting glucose/insuline ratio

  one month

• Plasma adiponectin

  one month

• plasma resistin

  one month

• plasma gherlin

  one month

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, Cairo Governorate, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Ahmed M kotb, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Ahmed Kotb

Study Record Dates

• First Submitted: July 13, 2015
• First Posted: July 16, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: November 1, 2018
• Last Updated: October 16, 2018

Record last verified: 2018-10

Locations

EG (1)