Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03703115 |
| Other study ID # |
88766603 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 14, 2018 |
| Est. completion date |
September 1, 2022 |
Study information
| Verified date |
January 2021 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 waist/hip 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 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.
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, metformin
500-1000 mg orally 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 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)u, 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
