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Trial registered on ANZCTR


Registration number
ACTRN12609000274279
Ethics application status
Approved
Date submitted
20/03/2009
Date registered
15/05/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
N-acetyl cysteine: could it be an effective adjuvant therapy in infertile women undergoing intra-cytoplasmic sperm injection (ICSI) in achieving more pregnancy?
Scientific title
In women undergoing intra-cytoplasmic sperm injection (ICSI) using gonadotropin releasing hormone agonist (GnRHa) long protocol, does addition of N-acetyl cysteine (NAC) in comparison to the standard protocol achieves more pregnancy?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 4505 0
Condition category
Condition code
Reproductive Health and Childbirth 4785 4785 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Triptorelin 0.1 mg subcutaneous injection daily from the midluteal phase of the pretreatment cycle followed directly by 1200 mg NAC orally daily in three divided doses (400mg each) starting from the first day of gonadotropin administration till the day of human chorionic gonadotrophin (hCG)
Intervention code [1] 4255 0
Treatment: Drugs
Comparator / control treatment
Triptorelin 0.1 mg subcutaneous injection daily from the midluteal phase of the pretreatment cycle till achieving endometrium < 5 mm, no ovarian cysts, and serum estradiol < 50 pg / ml, then the dose of triptorelin was reduced to 0.05 mg/day and ovarian stimulation was initiated with recombinant follicle stimulating hormone (rFSH) and human menopausal gonadotrophin (hMG). The dose was changed from day 6 of stimulation according to sequential transvaginal ultrasonography and serum estradiol. When at least three follicles had reached = 17 mm in diameter, human chorionic gonadotrophin (hCG), 10.000 IU was administered as a single intramuscular (IM) dose
Control group
Active

Outcomes
Primary outcome [1] 5645 0
Clinical pregnancy rate diagnosed by measuring serum human chorionic gonadotropin hormone and ultrasound scan
Timepoint [1] 5645 0
3 weeks after a (+)ve serum hCG
Secondary outcome [1] 241531 0
Granulosa cell apoptosis using Annexin V-Propidium iodide Detection Flow Cytometry
Timepoint [1] 241531 0
within 1 hour of follicular aspiration
Secondary outcome [2] 241532 0
Fertilization rate by inspecting the number of oocytes with 2 pronuclei and 2 polar bodies under dissecting microscope
Timepoint [2] 241532 0
16-18 hours after ICSI
Secondary outcome [3] 241533 0
Grade I embryo (equal blastomeres without fragmentation under the microscope)
Timepoint [3] 241533 0
At the time of embryo transfer (ET)
Secondary outcome [4] 241534 0
Ongoing pregnancy rate through ultrasound scan
Timepoint [4] 241534 0
12 weeks after a (+)ve serum hCG test

Eligibility
Key inclusion criteria
Women undergoing ICSI cycles for male infertility
Minimum age
No limit
Maximum age
37 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Age > 37 years, body mass index < 18 or > 29 kg/m2, cycles < 24 days or > 35 days, single ovary, day 3 follicle stimulating hormone 9.5 milli international unit/ml or more, basal total antral follicle count 6 or less, cases refused to sign a consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1693 0
Egypt
State/province [1] 1693 0

Funding & Sponsors
Funding source category [1] 4691 0
Self funded/Unfunded
Name [1] 4691 0
Eman, A. Elgindy
Address [1] 4691 0
Obstetrics & Gynecology department, Faculty of Medicine, Zagazig University, Zagazig city, Ash Sharqiyah, 44519
Country [1] 4691 0
Egypt
Primary sponsor type
Individual
Name
Eman, A. Elgindy
Address
Obstetrics & Gynecology department, Faculty of Medicine, Zagazig University, Zagazig city, Ash Sharqiyah, 44519
Country
Egypt
Secondary sponsor category [1] 4236 0
Individual
Name [1] 4236 0
Ahmed M. El-Huseiny
Address [1] 4236 0
Obstetrics & Gynecology department, Faculty of Medicine, Zagazig University, Zagazig city, Ash Sharqiyah, 44519
Country [1] 4236 0
Egypt
Secondary sponsor category [2] 4237 0
Individual
Name [2] 4237 0
Magdy I. Mostafa
Address [2] 4237 0
Obstetrics & Gynecology department, Faculty of Medicine, Cairo University, El Manial, Cairo, 11451
Country [2] 4237 0
Egypt
Secondary sponsor category [3] 4238 0
Individual
Name [3] 4238 0
Ahmed M. Gaballah
Address [3] 4238 0
Clinical Pathology department, Faculty of Medicine, Zagazig University, Zagazig city, Ash Sharqiyah, 44519
Country [3] 4238 0
Egypt
Secondary sponsor category [4] 4239 0
Individual
Name [4] 4239 0
Taha A. Ahmed
Address [4] 4239 0
Obstetrics & Gynecology department, Faculty of Medicine, Zagazig University, Zagazig city, Ash Sharqiyah, 44519
Country [4] 4239 0
Egypt

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The trial aims at testing the value of adding N-acetyl cysteine (as a powerful anti-oxidant) in achieving more pregnancies for infertile females undergoing intra-cytoplasmic sperm injection (ICSI) procedure using gonadotrophin releasing hormone agonist plus gonadotrophin ovarian stimulation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29418 0
Address 29418 0
Country 29418 0
Phone 29418 0
Fax 29418 0
Email 29418 0
Contact person for public queries
Name 12665 0
Magdy I. Mostafa
Address 12665 0
Obstetrics & Gynecology department, Faculty of Medicine, Cairo University, El Manial, Cairo, 11451
Country 12665 0
Egypt
Phone 12665 0
+20 1052 07305
Fax 12665 0
Email 12665 0
imagdy@link.net
Contact person for scientific queries
Name 3593 0
Eman, A. Elgindy
Address 3593 0
Obstetrics & Gynecology department, Faculty of Medicine, Zagazig University, Zagazig city, Ash Sharqiyah, 44519
Country 3593 0
Egypt
Phone 3593 0
+20 1274 91143
Fax 3593 0
Email 3593 0
eman_elgindy@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary