Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03703115
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Abdel-Maguid Ramzy, Cairo University

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.


Condition or disease Intervention/treatment Phase
Infertility Polycystic Ovary Syndrome Behavioral: Fasting Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Fasting on ICSI Outcomes in Patients With Polycystic Ovary Syndrome
Actual Study Start Date : October 14, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fasting
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
No food for 14 -16 hours with water intake and non caloric beverages then eating balanced meals over 8 to 10 hours
Other Name: Periodic fasting

No Intervention: Nonfasting
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)



Primary Outcome Measures :
  1. Rate of clinical pregnancy [ Time Frame: 10 weeks ]
    detection of gestationalsac, embryonal pole and fetal pulsations by ultrasonography


Secondary Outcome Measures :
  1. Body mass index [ Time Frame: 4 weeks of fasting ]
    The weight in kilograms divided by the squared height in meters

  2. Waist/ hip ratio [ Time Frame: 4 weeks of fasting ]
    The ratio of waist circumference in centimeters to the hip circumference in centimeters

  3. Concentration of fasting insulin [ Time Frame: 4 weeks of fasting ]
    Insulin level in serum after fasting for 8 hours measured as mIU/ml

  4. Concentration of free testosterone [ Time Frame: 4 weeks of fasting ]
    Free testosterone level in serum measured as ng/dL

  5. Number of days of stimulation with gonadotrophins [ Time Frame: 6 weeks ]
    Days of stimulation with gonadotrophins

  6. Number of ampoules of gonadotrophins [ Time Frame: 6 weeks ]
    total number of ampoules of gonadotrophins

  7. Number of M II oocytes retrieved [ Time Frame: Average 6 weeks ]
    Number of M II oocytes retrieved

  8. Number of grade1 and 2 embryos [ Time Frame: 6-7 weeks ]
    Number of grade1 and 2 embryos

  9. Number of frozen embryos [ Time Frame: 6 to 7 weeks ]
    Number of frozen embryos

  10. Number of freeze all cycles [ Time Frame: 6 to 7 weeks ]
    total number of freeze all cycles

  11. Number of cases with Ovarian Hyperstimulation Syndrome [ Time Frame: 6 to 8 weeks ]
    number of cases diagnosed with Ovarian Hyperstimulation Syndrome

  12. Rate of chemical pregnancy [ Time Frame: 10weeks ]
    number of cases with positive pregnancy test with no clinical pregnancy

  13. Rate of twin pregnancy [ Time Frame: 10 weeks ]
    presence of two gestational sacs detected by ultrasonography

  14. Rate of ectopic pregnancy [ Time Frame: 10 weeks ]
    the presence of gestational sac outside the uterine cavity detected by ultrasound

  15. Rate of Abortion [ Time Frame: 10-24 weeks ]
    the number of abortions clinically diagnosed per cycle

  16. Rate of preterm labour [ Time Frame: After 24 weeks of start of study ]
    labour after 20 weeks of gestation and before completed 37 weeks of gestation

  17. Rate of live birth [ Time Frame: After40 weeks of start of study ]
    Live birth rate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03703115


Contacts
Layout table for location contacts
Contact: Amira Dieb 00223682030 amirasaied2026@cu.edu.eg

Locations
Layout table for location information
Egypt
KasrELAiniH Recruiting
Cairo, Egypt
Contact: Abdelmaguid Ramzy, MD    00223682030    amramzy@gmail.com   
Contact: Amira Dieb    00223682030    amirasaied2026@cu.edu.gov   
Principal Investigator: Ramzy, MD         
Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Principal Investigator: Abdelmaguid Ramzy Cairo University

Layout table for additonal information
Responsible Party: Abdel-Maguid Ramzy, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03703115     History of Changes
Other Study ID Numbers: 88766603
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abdel-Maguid Ramzy, Cairo University:
ICSI
Polycystic ovary syndrome
Infertility
Fasting
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Cysts
Ovarian Diseases
Polycystic Ovary Syndrome
Infertility
Syndrome
Disease
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Cysts
Neoplasms
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases