Clinical trial NCT02499289: Effect of Ramadan Fasting on Ovulation and Insuline Resistance in Patients With PCOS
Official title: Does Prolonged Fasting Break the Vicious Circle of Polycystic Ovarian Syndrome of Insulin Resistance ?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-07-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: spontaneous ovulation measured by midluteal progesterone
timeFrame: one month
Secondary outcomes:
measure: clinical pregnancy
timeFrame: four months
measure: fasting glucose/insuline ratio
timeFrame: one month
measure: Plasma adiponectin
timeFrame: one month
measure: plasma resistin
timeFrame: one month
measure: plasma gherlin
timeFrame: one month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine, Ain Shams University
state: Al Qahirah
Study officials:
affiliation: Ain Shams University
name: Ahmed M kotb, MD
role: PRINCIPAL_INVESTIGATOR
References: