Effect of Fasting on ICSI Outcomes in Poor Responders
- Conditions
- Infertility
- Interventions
- Behavioral: No fastingBehavioral: Fasting
- Registration Number
- NCT03714009
- Lead Sponsor
- Kasr El Aini Hospital
- Brief Summary
This study is a prospective, randomized controlled trial conducted at the In Vitro Fertilization ( IVF) center of the Department of Obstetrics \& Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, Egypt, from October 2018 to September 2019, to determine the clinical effect of fasting on ICSI outcomes in poor responders 360 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).
All patients will start the ICSI cycle using the same treatment protocol. 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 ( Triglycerides (TGs), total cholesterol, High density Lipoprotein (HDL), Low density Lipoprotein (LDL), AntiMullerian Hormone (AMH), Basal Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2, Days of stimulation , dose of gonadotrophins, number of M II oocytes retrieved, number of grade1and 2 embryos, number of frozen embryos, freeze all cycles, Ovarian Hyperstimulation syndrome (OHSS), Chemical pregnancy rate, clinical pregnancy, twins, abortion, ectopic pregnancy, preterm labour, live birth rate
- Detailed Description
This study is a prospective, single-blinded (to the outcomes assessor), randomized controlled trial conducted at the In Vitro Fertilization ( IVF) center of the Department of Obstetrics \& Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, Egypt, from October 2018 to September 2019, to determine the clinical effect of fasting on ICSI outcomes in poor responder patients. Ethical committee approval was obtained. The study will include 360 infertile patients with poor ovarian reserve (POR )diagnosed by low Antral follicle count (AFC)( less than 5 follicles), Elevated basal follicle-stimulating hormone (FSH) (more than 10 IU/mL) and low anti-Mullerian hormone (AMH)(less than 1.5 ng/ml), previous POR (≤three oocytes with a conventional stimulation protocol). Women with diabetes, thyroid disorder or other endocrine dysfunctions, uterine abnormalities were excluded.Also severe oligo-astheno-teratozoospermia or azospermia are 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 plasma glucose, lipid profile ( Triglycerides (TGs), total cholesterol, High density Lipoprotein (HDL), Low density Lipoprotein (LDL),AntiMullerian Hormone (AMH), Basal Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2) All 360 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. 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 plasma glucose, lipid profile ( Triglycerides (TGs), total cholesterol, High density Lipoprotein (HDL), Low density Lipoprotein (LDL), 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.
On the sixth day of stimulation , a visit is scheduled to assess the ovarian response ( folliculometry) by TVS. Gonadotrophin releasing hormone antagonist (GnRH antagonist) which is Cetrorelix 0.25mg ( Cetrotide®, 0.25 mg/ vial, Merck Serono, is filled and mixed with diluent from a prefilled syringe with a 20 gauge needle) is given subcutaneously (S.C.) by 27-gauge needle starting from the 6th day of stimulation (fixed antagonist protocol).
Next visits are every other day for follow up using the TVS. The trigger by Human Chorionic Gonadotrophin (HCG)10000 I.U., I.M. ( Pregnyl, Organon) is given when at least 3 follicles reach 18mm in mean diameter or more and E2 level is less than 2500 pg/ml. Ovum retrieval is done 34 hours after HCG injection and embryo transfer using Wallace catheter on day 2 to 3. Luteal support includes natural Progesterone 400 mg 1x2 as rectal suppository, Folic acid 0.5 mg orally once daily, Amoxicillin-Clavulanic Acid 1gm 1x2x7 orally, Progesterone 100 I.M. injections daily for 10 days, Acetylsalicylic Acid (75 mg) orally once daily 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 plasma glucose, lipid profile ( Triglycerides (TGs), total cholesterol, High density Lipoprotein (HDL), Low density Lipoprotein (LDL), AntiMullerian Hormone (AMH), Basal Follicle Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2, Days of stimulation , dose of gonadotrophins, number of M II oocytes retrieved, number of grade1and 2 embryos, number of frozen embryos, freeze all cycles, Ovarian Hyperstimulation syndrome (OHSS), Chemical pregnancy rate, clinical pregnancy, twins, abortion, ectopic pregnancy, preterm labour, live birth rate
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 360
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non fasting group No fasting no fasting, patients will have usual balanced diet as 3 meals and 2 snacks all over the day. They should take adequate water and non calorie beverages intake daily (2-3 liters) Fasting group 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. They should take adequate water and non calorie beverages intake daily (2-3 liters)
- Primary Outcome Measures
Name Time Method clinical pregnancy rate per cycle 10 weeks detection of gestationalsac, embryonal pole and fetal pulsations by ultrasonography
- Secondary Outcome Measures
Name Time Method number of M II oocytes retrieved 6 weeks number of M II oocytes retrieved
Body mass index 4 weeks of fasting The weight in kilograms divided by the squared height in meters
Waist/Hip ratio 4 weeks of fasting The ratio of waist circumference in centimeters to the hip circumference in centimeters
Number of days of stimulation with gonadotrophins 6 weeks Days of stimulation with gonadotrophins
Number of ampoules of gonadotrophins 6 weeks total number of ampoules of gonadotrophins
number of frozen embryos 6-7 weeks number of frozen embryos
Rate of chemical pregnancy rate 10 weeks number of cases with positive pregnancy test with no clinical pregnancy
number of grade1and 2 embryos 6-7 weeks number of grade1and 2 embryos
number of freeze all cycles 6 weeks total number of freeze all cycles
Rate of abortion per cycle 10-24 weeks after embryo transfer number of abortions clinically detected per cycle
number of cancelled cycles 6 weeks total number of cancelled cycles
Rate of twin pregnancy 10 weeks presence of two gestational sacs detected by ultrasonography
Rate of ectopic pregnancy 10 weeks the presence of gestational sac outside the uterine cavity detected by ultrasound
Rate of preterm labour After 24 weeks of start of study labour after 20 weeks of gestation and before completed 37 weeks of gestation
live birth rate After40 weeks of start of study live birth rate
Trial Locations
- Locations (1)
KasrELAiniH
🇪🇬Cairo, Egypt