Infertility Clinical Trial
Official title:
Effect of Fasting on ICSI Outcomes in Poor Responders
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
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
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03607409 -
Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
|
||
Recruiting |
NCT02312076 -
GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles
|
Phase 4 | |
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Completed |
NCT03287479 -
Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®)
|
N/A | |
Terminated |
NCT03522350 -
Randomized Trial Comparing EmbryoScope With EmbryoScope+.
|
N/A | |
Completed |
NCT04496284 -
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
|
N/A | |
Completed |
NCT03623659 -
pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
|
N/A | |
Completed |
NCT03895099 -
New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors
|
Phase 3 | |
Active, not recruiting |
NCT04142112 -
Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation
|
N/A | |
Completed |
NCT03152643 -
Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer
|
N/A | |
Recruiting |
NCT03683771 -
Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
|
||
Recruiting |
NCT03161119 -
Comparing Two Different Embryo Transfer Catheters
|
N/A | |
Completed |
NCT04108039 -
Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.
|
N/A | |
Completed |
NCT03678610 -
Handling Medium for ICSI With Ionomycin and Latrunculin A
|
N/A | |
Completed |
NCT03677492 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)
|
N/A | |
Completed |
NCT03678818 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)
|
N/A | |
Completed |
NCT03678584 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
|
N/A | |
Completed |
NCT03678597 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
|
N/A | |
Completed |
NCT03678558 -
Oocyte Vitrification Aided With Cytochalasin B
|
N/A | |
Completed |
NCT03678571 -
Oocyte Vitrification Aided With Latrunculin A
|
N/A |