Infertility Clinical Trial
Official title:
Effect of Fasting on ICSI Outcomes in Poor Responders
Verified date | September 2020 |
Source | Kasr El Aini Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 360 |
Est. completion date | September 1, 2019 |
Est. primary completion date | September 1, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
The study will include: 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | KasrELAiniH | Cairo |
Lead Sponsor | Collaborator |
---|---|
Kasr El Aini Hospital |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | clinical pregnancy rate per cycle | detection of gestationalsac, embryonal pole and fetal pulsations by ultrasonography | 10 weeks | |
Secondary | Body mass index | The weight in kilograms divided by the squared height in meters | 4 weeks of fasting | |
Secondary | Waist/Hip ratio | The ratio of waist circumference in centimeters to the hip circumference in centimeters | 4 weeks of fasting | |
Secondary | Number of days of stimulation with gonadotrophins | Days of stimulation with gonadotrophins | 6 weeks | |
Secondary | Number of ampoules of gonadotrophins | total number of ampoules of gonadotrophins | 6 weeks | |
Secondary | number of M II oocytes retrieved | number of M II oocytes retrieved | 6 weeks | |
Secondary | number of grade1and 2 embryos | number of grade1and 2 embryos | 6-7 weeks | |
Secondary | number of frozen embryos | number of frozen embryos | 6-7 weeks | |
Secondary | number of freeze all cycles | total number of freeze all cycles | 6 weeks | |
Secondary | number of cancelled cycles | total number of cancelled cycles | 6 weeks | |
Secondary | Rate of chemical pregnancy rate | number of cases with positive pregnancy test with no clinical pregnancy | 10 weeks | |
Secondary | Rate of twin pregnancy | presence of two gestational sacs detected by ultrasonography | 10 weeks | |
Secondary | Rate of abortion per cycle | number of abortions clinically detected per cycle | 10-24 weeks after embryo transfer | |
Secondary | Rate of ectopic pregnancy | the presence of gestational sac outside the uterine cavity detected by ultrasound | 10 weeks | |
Secondary | Rate of preterm labour | labour after 20 weeks of gestation and before completed 37 weeks of gestation | After 24 weeks of start of study | |
Secondary | live birth rate | live birth rate | After40 weeks of start of study |
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