The Effect of Fasting on ICSI Outcomes in Patients With Polycystic Ovary Syndrome

NCT03703115 | Withdrawn

• 1 other identifier: 88766603
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Design and protocol of PCO fasting research: This study is a pilot prospective, single-blinded (to the health assessor), randomized controlled trial conducted at the In Vitro Fertilization ( IVF) center of the Department of Obstetrics \& Gynecology, Kasr El-Ainy Hospital, Cairo University, Egypt, from October 2018 to September 2019, to determine the clinical effect of fasting on ICSI outcomes in PCOS patients. Ethical committee approval was obtained. The study will include 100 infertile patients with PCOS diagnosed according to Rotterdam criteria of PCOS and who are candidates for ICSI cycle. Women with diabetes, thyroid disorder or other endocrine dysfunctions, uterine abnormalities were excluded. All patients are informed about the study and consent is given by those who accept to participate. Careful history taking include infertility type, duration , cause, obstetric history, medical and surgical history and demographic distribution is taken. Full physical examination and 2 dimensional (2D) transvaginal sonography (TVS) are done on day 2 to 5 of menses to assess antral follicle count, uterus and adnexa . Body mass index (BMI) and waist/hip ratio (WHR) are calculated, Blood samples are taken for Fasting insulin , fasting plasma glucose, Homeostatic model assessment (HOMA index), lipid profile and hormonal profile are done. All 100 participants will be randomized withdrawing closed envelopes for each patient into group A and group B . Group (A): patients will have periodic fasting for 4 weeks prior to the treatment cycle. The fasting method involves daily fasts of 14-16hours and restrict eating to an 8-10 hour "eating window" as 2-3 or more meals of balanced diet. Group (B): no fasting, patients will have usual balanced diet as 3 meals and 2 snacks all over the day. Both groups should take adequate water and non calorie beverages intake daily (2-3 liters) Subjects are instructed to wait for spontaneous menses, or to be prescribed progestins orally (as Norethisterone 5mg) twice daily for 21 days starting from the fifth day of menses. Patients should continue taking oral metformin 500-1000 mg daily, until confirmation of pregnancy. The next visit is scheduled on day 2 of next cycle when transvaginal ultrasound is done to confirm that endometrial thickness \<5mm, no ovarian cyst by ultrasound. Body mass index (BMI) and waist/hip ratio (WHR) are calculated. Blood samples are taken for Fasting insulin , fasting plasma glucose, Homeostatic model assessment (HOMA) index, lipid profile ( Triglycerides (TGs), total cholesterol, High density Lipoprotein (HDL), Low density Lipoprotein (LDL), free and total testosterone , Sex Hormone Binding Globulin (SHBG), Free Androgen index (FAI), AntiMullerian Hormone (AMH), Basal Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2),and then antagonist protocol is followed. Gonadotropins as Intramuscular (I.M.) injections of 150-300 (International units) I.U. of highly purified Human Menopausal Gonadotropins daily (Merional, 75 I.U. /vial, IBSA). and Urofollitropin or highly purified human follicle stimulating hormone(Fostimon®, 75 I.U. /vial, IBSA) are give in a ratio of 1:1.The dose is adjusted according to the age, BMI, Antral follicle count (AFC), serum levels of AMH, FSH and ovarian response. Fixed antagonist protocol is given and follow up until embryo transfer(ET). Quantitative ß- HCG in serum after is done after 14 days of embryo transfer.TVS is performed to detect clinical pregnancy at 6-7 weeks of gestation. Primary outcome is clinical pregnancy rate per cycle. Secondary outcomes include Body mass index (BMI) and waist/hip ratio (WHR), fasting insulin , fasting plasma glucose, Homeostatic model assessment (HOMA) index, lipid profile and other ICSI outcomes.

Conditions

Infertility; Polycystic Ovary Syndrome

Keywords

ICSI; Polycystic ovary syndrome; Infertility; Fasting

Outcome Measures

Primary Outcomes (1)

• Rate of clinical pregnancy

  detection of gestationalsac, embryonal pole and fetal pulsations by ultrasonography

  10 weeks

Secondary Outcomes (17)

• Body mass index

  4 weeks of fasting

• Waist/ hip ratio

  4 weeks of fasting

• Concentration of fasting insulin

  4 weeks of fasting

• Concentration of free testosterone

  4 weeks of fasting

• Number of days of stimulation with gonadotrophins

  6 weeks

Study Arms (2)

Fasting

ACTIVE COMPARATOR

Patients will have periodic fasting for 4 weeks prior to the treatment cycle. The fasting method involves daily fasts of 14-16hours and restrict eating to an 8-10 hour "eating window" as 2-3 or more meals of balanced diet with 2-3 litres of water and non calorie fluids allover the day.

Behavioral: Fasting

Nonfasting

NO INTERVENTION

Patients will have usual balanced diet as 3 meals and 2 snacks all over the day. Both groups should take adequate water and non calorie beverages intake daily ( 2-3 liters daily)

Interventions

Fasting BEHAVIORAL

No food for 14 -16 hours with water intake and non caloric beverages then eating balanced meals over 8 to 10 hours

Also known as: Periodic fasting

Fasting

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• infertile patients with polycystic ovary syndrome diagnosed according to the Rotterdam criteria scheduled for ICSI

You may not qualify if:

• women with diabetes, thyroid disorders and other endocrinologic disorders
• women with uterine abnormalities

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

KasrELAiniH

Cairo, Egypt

Location

MeSH Terms

Conditions

Infertility; Polycystic Ovary Syndrome; Fasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

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

Study Officials

• Abdelmaguid Ramzy

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2018
• First Posted: October 11, 2018
• Study Start: October 14, 2018
• Primary Completion: April 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 30, 2023

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)