Ignite Creation Date:
2024-05-06 @ 12:13 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03703115
Status:
WITHDRAWN
Last Update Posted:
2023-08-30
First Post:
2018-09-29
Brief Title:
The Effect of Fasting on ICSI Outcomes in Patients With Polycystic Ovary Syndrome
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
The Effect of Fasting on ICSI Outcomes in Patients With Polycystic Ovary Syndrome
Status:
WITHDRAWN
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
There is no commitment from the patient to maintain fasting in both the control and case groups
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 waisthip 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 waisthip 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 E2and then antagonist protocol is followed Gonadotropins as Intramuscular IM injections of 150-300 International units IU of highly purified Human Menopausal Gonadotropins daily Merional 75 IU vial IBSA and Urofollitropin or highly purified human follicle stimulating hormoneFostimon 75 IU vial IBSA are give in a ratio of 11The 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 transferET Quantitative ß- HCG in serum after is done after 14 days of embryo transferTVS 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 waisthip ratio WHR fasting insulin fasting plasma glucose Homeostatic model assessment HOMA index lipid profile and other ICSI outcomes
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 waisthip 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 waisthip 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 E2and then antagonist protocol is followed Gonadotropins as Intramuscular IM injections of 150-300 International units IU of highly purified Human Menopausal Gonadotropins daily Merional 75 IU vial IBSA and Urofollitropin or highly purified human follicle stimulating hormoneFostimon 75 IU vial IBSA are give in a ratio of 11The 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 transferET Quantitative ß- HCG in serum after is done after 14 days of embryo transferTVS 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 waisthip ratio WHR fasting insulin fasting plasma glucose Homeostatic model assessment HOMA index lipid profile and other ICSI outcomes
Detailed Description:
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 waisthip ratio WHR are calculated Blood samples are taken for Fasting insulin fasting plasma glucose Homeostatic model assessment HOMA index lipid profile Triglycerides 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 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 waisthip 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 E2and then antagonist protocol is followed Gonadotropins as Intramuscular IM injections of 150-300 International units IU of highly purified Human Menopausal Gonadotropins daily Merional 75 IU vial IBSA and Urofollitropin or highly purified human follicle stimulating hormoneFostimon 75 IU vial IBSA are give in a ratio of 11The 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 025mg Cetrotide 025 mg vial Merck Serono is filled and mixed with diluent from a prefilled syringe with a 20 gauge needle is given subcutaneously SC 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 HCG10000 IU IM Pregnyl Organon is given when at least 3 follicles reach 18mm in mean diameter or more and E2 level is less than 2500 pgml 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 05 mg orally once daily Amoxicillin-Clavulanic Acid 1gm 1x2x7 orally Progesterone 100 IM injections daily for 10 days Acetylsalicylic Acid 75 mg orally once daily metformin 500-1000 mg orally daily
Quantitative ß- HCG in serum after is done after 14 days of embryo transferTVS 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 waisthip 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 free and total testosterone Sex Hormone Binding Globulin SHBGu Free Androgen index FAI 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
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 waisthip ratio WHR are calculated Blood samples are taken for Fasting insulin fasting plasma glucose Homeostatic model assessment HOMA index lipid profile Triglycerides 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 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 waisthip 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 E2and then antagonist protocol is followed Gonadotropins as Intramuscular IM injections of 150-300 International units IU of highly purified Human Menopausal Gonadotropins daily Merional 75 IU vial IBSA and Urofollitropin or highly purified human follicle stimulating hormoneFostimon 75 IU vial IBSA are give in a ratio of 11The 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 025mg Cetrotide 025 mg vial Merck Serono is filled and mixed with diluent from a prefilled syringe with a 20 gauge needle is given subcutaneously SC 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 HCG10000 IU IM Pregnyl Organon is given when at least 3 follicles reach 18mm in mean diameter or more and E2 level is less than 2500 pgml 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 05 mg orally once daily Amoxicillin-Clavulanic Acid 1gm 1x2x7 orally Progesterone 100 IM injections daily for 10 days Acetylsalicylic Acid 75 mg orally once daily metformin 500-1000 mg orally daily
Quantitative ß- HCG in serum after is done after 14 days of embryo transferTVS 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 waisthip 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 free and total testosterone Sex Hormone Binding Globulin SHBGu Free Androgen index FAI 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None