The Effect of Fasting on ICSI Outcomes in Patients With Polycystic Ovary Syndrome
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|ClinicalTrials.gov Identifier: NCT03703115|
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : October 19, 2018
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
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)
- Rate of clinical pregnancy [ Time Frame: 10 weeks ]detection of gestationalsac, embryonal pole and fetal pulsations by ultrasonography
- Body mass index [ Time Frame: 4 weeks of fasting ]The weight in kilograms divided by the squared height in meters
- Waist/ hip ratio [ Time Frame: 4 weeks of fasting ]The ratio of waist circumference in centimeters to the hip circumference in centimeters
- Concentration of fasting insulin [ Time Frame: 4 weeks of fasting ]Insulin level in serum after fasting for 8 hours measured as mIU/ml
- Concentration of free testosterone [ Time Frame: 4 weeks of fasting ]Free testosterone level in serum measured as ng/dL
- Number of days of stimulation with gonadotrophins [ Time Frame: 6 weeks ]Days of stimulation with gonadotrophins
- Number of ampoules of gonadotrophins [ Time Frame: 6 weeks ]total number of ampoules of gonadotrophins
- Number of M II oocytes retrieved [ Time Frame: Average 6 weeks ]Number of M II oocytes retrieved
- Number of grade1 and 2 embryos [ Time Frame: 6-7 weeks ]Number of grade1 and 2 embryos
- Number of frozen embryos [ Time Frame: 6 to 7 weeks ]Number of frozen embryos
- Number of freeze all cycles [ Time Frame: 6 to 7 weeks ]total number of freeze all cycles
- Number of cases with Ovarian Hyperstimulation Syndrome [ Time Frame: 6 to 8 weeks ]number of cases diagnosed with Ovarian Hyperstimulation Syndrome
- Rate of chemical pregnancy [ Time Frame: 10weeks ]number of cases with positive pregnancy test with no clinical pregnancy
- Rate of twin pregnancy [ Time Frame: 10 weeks ]presence of two gestational sacs detected by ultrasonography
- Rate of ectopic pregnancy [ Time Frame: 10 weeks ]the presence of gestational sac outside the uterine cavity detected by ultrasound
- Rate of Abortion [ Time Frame: 10-24 weeks ]the number of abortions clinically diagnosed per cycle
- 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
- Rate of live birth [ Time Frame: After40 weeks of start of study ]Live birth rate
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
|Contact: Amira Diebemail@example.com|
|Contact: Abdelmaguid Ramzy, MD 00223682030 firstname.lastname@example.org|
|Contact: Amira Dieb 00223682030 email@example.com|
|Principal Investigator: Ramzy, MD|
|Principal Investigator:||Abdelmaguid Ramzy||Cairo University|