|- candidate number||9253|
|- NTR Number||NTR2816|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-mrt-2011|
|- Secondary IDs||2000 EIFCIVF|
|- Public Title||Can antioxidants supplementation improve ICSI/IVF outcomes in women undergoing IVF/ICSI treatment cycles? Randomised controlled study.|
|- Scientific Title||Antioxidants and IVF/ICSI outcomes.|
|- hypothesis||Good oocyte quality and maturity are important prerequisites for higher fertilization and implantation rates in IVF/ICSI treatment cycles. Reactive oxygen species (ROS) are produced within ovarian follicles, especially during ovulation process, and it is thought that increased ROS activity may be a cause of impaired oocyte maturation and higher rate of failure of IVF/ICSI cycles. It has been approved that antioxidants administration improves sperm numbers and morphology. In contrast, the effect of antioxidants did not studied properlly yet in women undergoing IVF/ICSI treatment.|
|- Healt Condition(s) or Problem(s) studied||Infertility, Antioxidants, IVF, ICSI, Oocyt quality|
|- Inclusion criteria||1. Female age 18 – 45 years;|
2. Menstrual cycles between 25 and 34 days;
3. Absence of uterine abnormalities;
4. Absence of uterine abnormalities;
5. Has an indication for IVF/ICSI.
|- Exclusion criteria||Poor sperm quality with counts less than 1 million or azospermia.|
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2011|
|- planned closingdate||1-dec-2011|
|- Target number of participants||170|
|- Interventions||At the start of down regulation treatment or previous cycle precceding the IVF cycle, patients will be randomized into two groups. The antioxidant group (study group) will receive oral antioxidants medication (Octatron) 2 tablets/day up to the pregnancy test.
1. Ovarian stimulation will be initiated with HP- FSH (HP FSH; Fostimon; IBSA, Egypt) from cycle day 2 or 3 and continued until the day of ovulation induction. A fixed dose of HP-FSH will be used, either 225 IU - 300 IU per day for the first 5 days, according to age, body mass index, basal FSH level, and antral follicle count. After 5 days, doses will be adjusted according to ovarian response;
2. Different downrgulation protocols will be used either daily midluteal long GnRH protocol, 01 mg, SC, Decapeptyl( Ferring,) or flexible GnRH antagonist ganirelix (Cetrotide 0.25 mg; Organon) is initiated and continued up to and including the day of ovulation induction;
3. When at least two follicles reach a size of 18 mm, both groups will receive hCG (10,000 IU SC) for final oocyte maturation, followed by OPU 34-36 hours later.
|- Primary outcome||1. Number of retrieved oocytes;|
2. Number of mature oocytes;
3. Number of embryos obtained.
|- Secondary outcome||1. Implantation rate;|
2. Biochemical and clinical pregnancy rate;
3. Duration of stimulation;
4. Amount of FSH and adverse events.
|- Timepoints||1. Oocyte quality on day of ovum pickup;|
2. Fertilization rate on day 2-5;
3. Biochemicalpregnancy rate after 14 days from embryo transfer;
4. Clinical pregnancy rate: 7 weeks pregnancy plus fetal heart rate by ultrasound.
|- Trial web site||www.EIFCIVF.COM.EG|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD Mohamed A.F. Youssef|
|- CONTACT for SCIENTIFIC QUERIES||MD Mohamed A.F. Youssef|
|- Sponsor/Initiator |
(Source(s) of Monetary or Material Support)
|Egyptian International Fertility IVF center- Private center, Cairo, Egypt|
|- Brief summary||BACKGROUND: |
Good oocyte quality and maturity are important prerequisites for higher fertilization and implantation rates in IVF/ICSI treatment cycles. Reactive oxygen species (ROS) are produced within ovarian follicles, especially during ovulation process, and it is thought that increased ROS activity may be a cause of impaired oocyte maturation and higher rate of failure of IVF/ICSI cycles. It has been approved that antioxidants administration improves sperm numbers and morphology. In contrast, the effect of antioxidants did not studied properlly yet in women undergoing IVF/ICSI treatment.
Randomized controlled trial using computer generated list and closed opaque envelops comparing the effect of antioxidants supplementation on IVF outcomes will be conducted on 170 women with different indications for IVF/ICSI, will be randomized into 2 groups. Study group (n=85) will be supplemented with antioxidant supplementation daily from the cycle preceding IVF/ICSI cycle and the control group (n=85) will not.
Primary outcome: Number of retrieved oocytes, number of mature oocytes, and number of embryos obtained.
Secondary outcomes: Implantation rate, clinical pregnancy rate, duration of stimulation, amount of FSH and adverse events.
|- Main changes (audit trail)|
|- RECORD||19-mrt-2011 - 29-mrt-2011|