Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000697684
Ethics application status
Approved
Date submitted
5/06/2014
Date registered
2/07/2014
Date last updated
2/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The adjuvant effect of metformin and N-acetylcysteine to clomiphene citrate in induction of ovulation and pregnancy rate in patients with Polycystic Ovary Syndrome
Scientific title
The adjuvant effect of metformin and N-acetylcysteine to clomiphene citrate in induction of ovulation and pregnancy rate in patients with Polycystic Ovary Syndrome.
Secondary ID [1] 284740 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polycystic Ovary Syndrome 292103 0
Condition category
Condition code
Reproductive Health and Childbirth 292439 292439 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
120 women with PCOS were randomly divided to 3 groups: group I (40 women) received clomiphene citrate (CC) only100 mg orally in two divided doses from day 3 until day 7 of the menstrual cycle, group II (40 women) received CC 100 mg orally in two divided doses from day 3 until day 7 of the menstrual cycle plus N-acetyl cysteine (NAC) 1200 mg orally in two divided doses in the form of powder inserted in small pockets to be diluted into one standard glass of water from day 3 until day 7 of the menstrual cycle and group III (40 women) received CC 100 mg orally in two divided doses from day 3 until day 7 of the menstrual cycle plus metformin 500 mg orally three times daily continuously for 4 weeks
Monitoring through A transvaginal ultrasonography (TVS) using Toshiba femio 5 (Toshiba Medical Solutions Inc., Ultrasound Division, Japan) equipped with a 6.5 MHz transvaginal transducer on alternate days starting from cycle day 9 till ovulation to determine the follicular number, size, endometrial thickness and pattern and evidence of follicular rupture.
Intervention code [1] 289525 0
Treatment: Drugs
Comparator / control treatment
the CC only treatment is the control arm.
Control group
Active

Outcomes
Primary outcome [1] 292294 0
pregnancy rate (clinical pregnancy defined as the presence of gestational sac containing fetal heartbeats on ultrasound scan)
Timepoint [1] 292294 0
2 weeks after missed period
Secondary outcome [1] 308663 0
endometrial thickness measured by transvaginal ultrasound
Timepoint [1] 308663 0
at Baseline and every 2 days till ovulation
Secondary outcome [2] 308664 0
size of follicles measured by transvaginal ultrasound
Timepoint [2] 308664 0
at Baseline and every 2 days till ovulation

Eligibility
Key inclusion criteria
women with PCOS trying to fall pregnant
Minimum age
19 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. women with endocrinological abnormalities as thyroid dysfunction or abnormal prolactin levels
2. women with hypothalamic or pituitary dysfunctions
3. women with other causes of infertility as tubal factor, abnormal uterine cavity and male factor evaluated.
4.Women with ovarian cysts
5.women with allergy to used medications.
6. Patients who had received any hormonal medications (except progesterone for withdrawal bleeding) for at least 3 months before the study.

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
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2012
Actual
1/09/2012
Date of last participant enrolment
Anticipated
31/03/2014
Actual
31/03/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 6094 0
Egypt
State/province [1] 6094 0
Cairo

Funding & Sponsors
Funding source category [1] 289353 0
Self funded/Unfunded
Name [1] 289353 0
Ahmed Maged
Country [1] 289353 0
Egypt
Primary sponsor type
Individual
Name
Ahmed Maged
Address
Kasr Alaini medical school. 135 King Faisal Street Haram Giza
postal code 12151
Country
Egypt
Secondary sponsor category [1] 288038 0
Individual
Name [1] 288038 0
Aly Abdelhafez
Address [1] 288038 0
Kasr Alaini medical school. 420 Haram street Haram Giza.postal code 12163
Country [1] 288038 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291122 0
Cairo university
Ethics committee address [1] 291122 0
22 Kasr Alaini street Cairo.postal code 12254
Ethics committee country [1] 291122 0
Egypt
Date submitted for ethics approval [1] 291122 0
01/06/2014
Approval date [1] 291122 0
07/07/2012
Ethics approval number [1] 291122 0

Summary
Brief summary
to assess the adjuvant effect of metformine and N-acetylcysteine to clomiphene citrate in induction of ovulation in patients with PCOS
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48974 0
A/Prof Ahmed Maged
Address 48974 0
Kasr Alaini medical school. 135 King Faisal Street Haram Giza. Postal code 12151
Country 48974 0
Egypt
Phone 48974 0
+20201005227404
Fax 48974 0
Email 48974 0
prof.ahmedmaged@gmail.com
Contact person for public queries
Name 48975 0
A/Prof Ahmed Maged
Address 48975 0
Kasr Alaini medical school. 135 King Faisal Street Haram Giza. Postal code 12151
Country 48975 0
Egypt
Phone 48975 0
+20201005227404
Fax 48975 0
Email 48975 0
prof.ahmedmaged@gmail.com
Contact person for scientific queries
Name 48976 0
A/Prof Ahmed Maged
Address 48976 0
Kasr Alaini medical school. 135 King Faisal Street Haram Giza. Postal code 12151
Country 48976 0
Egypt
Phone 48976 0
+20201005227404
Fax 48976 0
Email 48976 0
prof.ahmedmaged@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.