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Trial registered on ANZCTR


Registration number
ACTRN12610000619044
Ethics application status
Approved
Date submitted
27/07/2010
Date registered
29/07/2010
Date last updated
29/07/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clomiphene citrate with intrauterine insemination or clomiphene citrate and timed intercourse as first line treatment in women with polycystic ovary syndrome
Scientific title
Efficacy of ovulation induction with Clomiphene citrate and intrauterine insemination versus Clomiphene citrate with timed intercourse for achieving pregnancy in patients with polycystic ovary syndrome (PCOS)
Secondary ID [1] 252310 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
polycystic ovary syndrome 257819 0
Condition category
Condition code
Metabolic and Endocrine 257989 257989 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clomiphene citrate and intrauterine insemination.
Clomiphene citrate (Clomid tablets (registered trademark); Global Napi Pharmaceuticals, Cairo, Egypt) was administered orally for 5 days starting from day 3 of spontaneous or induced menstruation using a starting dose of 50 mg daily. If ovulation did not occur, the dose was increased by 50 mg in successive cycles until the ovulation was achieved or up to a maximal dose of 150 mg daily. Patients were monitored by transvaginal ultrasound for the mean follicular diameter and endometrial thickness in the days 10, 12, and 14 of the cycle. human chorionic gonadotropin (hCG ) a total of 10,000 IU Intramuscular (IM) (Choriomon; Institut Biochimique SA (IBSA), Lugano, Switzerland) was given when one follicle measured at least 18 mm was found. Intrauterine insemination(IUI) was performed 32-36 hours after hCG injection. All couples underwent a maximum of three cycles of treatment. Semen preparation was done utilizing swim-up technique. 0.5 mL of the sperm suspension was introduced into the uterine cavity using a flexible intrauterine cannula (Gynetics Medical Products N.V. Harmont, Achel, Belgium).

So both treatments including human chorionic gonadotropin (hCG) injection will be given at the same time with the following sequence; Clomiphene citrate followed by ultrasound scanning, then human chorionic gonadotropin (hCG) was given to trigger ovulation once evidence of mature follicle (18mm) appeared by ultrasound scanning. Lastly, intrauterine insemination(IUI) was done 32-36 hours after human chorionic gonadotropin (hCG) injection.
Intervention code [1] 256881 0
Treatment: Drugs
Comparator / control treatment
clomiphene citrate and timed vaginal intercourse.
Clomiphene citrate (Clomid tablets (registered trademark) ; Global Napi Pharmaceuticals, Cairo, Egypt) was administered orally for 5 days starting from day 3 of spontaneous or induced menstruation using a starting dose of 50 mg daily. If ovulation did not occur, the dose was increased by 50 mg in successive cycles until the ovulation was achieved or up to a maximal dose of 150 mg daily. Patients were monitored by transvaginal ultrasound for the mean follicular diameter and endometrial thickness in the days 10, 12, and 14 of the cycle. human chorionic gonadotropin (hCG ) a total of 10,000 IU Intramuscular (IM) (Choriomon; Institut Biochimique SA (IBSA), Lugano, Switzerland) was given when one follicle measured at least 18 mm was found. Timed vaginal intercourse was performed 32-36 hours after hCG injection. All couples underwent a maximum of three cycles of treatment.
Control group
Active

Outcomes
Primary outcome [1] 258853 0
Clinical pregnancy rate.
Biochemical pregnancy was considered when serum B-hCG was 50mIU/ml or more 2 weeks after either timed vaginal intercourse or intrauterine insemination(IUI), meanwhile the sonographic evidence for intrauterine gestational sac at 6 weeks gestation were considered criteria to define a clinical pregnancy.
Timepoint [1] 258853 0
Per cycle i.e. following each treatment cycle, either Clomiphene citrate /intrauterine insemination (CC/IUI) cycle or Clomiphene citrate / timed intercourse(CC/TI) cycle
Secondary outcome [1] 264977 0
endometrial thickness monitored by transvaginal ultrasound scanning
Timepoint [1] 264977 0
at the time of human chorionic gonadotropin (hCG) administration

Eligibility
Key inclusion criteria
polycystic ovary syndrome
No other infertility factors
No previous use of ovarian stimulation drugs
Minimum age
20 Years
Maximum age
39 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Congenital adrenal hyperplasia,
Cushing syndrome,
Androgen secreting tumors

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)
sealed opaque envelops
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random numeric table
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
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] 2786 0
Egypt
State/province [1] 2786 0

Funding & Sponsors
Funding source category [1] 257343 0
Hospital
Name [1] 257343 0
Mansoura University Hospitals
Address [1] 257343 0
Faculty of Medicine, Mansoura University,Dakahlia Governorate, El-Gomhoria street. Mansoura, Egypt. Postcode:35511.
Country [1] 257343 0
Egypt
Primary sponsor type
Individual
Name
Hatem Abu Hashim
Address
Department of Obstetrics & Gynecology, Faculty of Medicine, Mansoura University, Dakahlia Governorate, El-Gomhoria street. Mansoura, Egypt. Postcode:35511.
Country
Egypt
Secondary sponsor category [1] 256581 0
Individual
Name [1] 256581 0
Osama Ombar
Address [1] 256581 0
Department of Diagnostic Radiology, Faculty of Medicine, Mansoura University, Dakahlia Governorate, El-Gomhoria street. Mansoura, Egypt. Postcode:35511.
Country [1] 256581 0
Egypt
Secondary sponsor category [2] 256582 0
Individual
Name [2] 256582 0
Ibrahim Abd Elaal
Address [2] 256582 0
Department of Clinical pathology, Faculty of Medicine, Mansoura University, Dakahlia Governorate, El-Gomhoria street. Mansoura, Egypt. Postcode:35511.
Country [2] 256582 0
Egypt

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259364 0
Mansoura University Hospital Research Ethics Committee
Ethics committee address [1] 259364 0
Faculty of Medicine, Mansoura University, Dakahlia Governorate, El-Gomhoria street. Mansoura, Egypt. Postcode:35511
Ethics committee country [1] 259364 0
Egypt
Date submitted for ethics approval [1] 259364 0
02/04/2007
Approval date [1] 259364 0
27/04/2007
Ethics approval number [1] 259364 0
FMH-192-X

Summary
Brief summary
The primary purpose of this study is to compare the efficacy of clomiphene citrate (an oral medication given to stimulate the ovaries, resulting in the release of more eggs) followed by intrauterine insemination (a procedure that places sperm directly into the uterus) at the expected time of ovulation versus Clomiphene citrate with timed vaginal intercourse ( i.e. natural intercourse around the expected time of ovulation) as the first-line treatment option to achieve pregnancy for subfertility due to absence of ovulation in cases of polycystic ovary syndrome (PCOS) which is a condition where the ovaries contain more small follicles (the sacs in which eggs develop) than normal. It affects menstruation, resulting in irregular periods or no periods at all, prevents ovulation and causes excessive body hair.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31438 0
Address 31438 0
Country 31438 0
Phone 31438 0
Fax 31438 0
Email 31438 0
Contact person for public queries
Name 14685 0
Hatem Abu Hashim
Address 14685 0
Department of Obstetrics & Gynecology, Mansoura Faculty of Medicine, Mansoura University, Dakahlia Governorate, El-Gomhoria street. Mansoura, Egypt. Postcode:35511
Country 14685 0
Egypt
Phone 14685 0
+20502300002
Fax 14685 0
Email 14685 0
hatem_ah@hotmail.com
Contact person for scientific queries
Name 5613 0
Hatem Abu Hashim
Address 5613 0
Department of Obstetrics & Gynecology, Mansoura Faculty of Medicine, Mansoura University, Dakahlia Governorate, El-Gomhoria street. Mansoura, Egypt. Postcode:35511
Country 5613 0
Egypt
Phone 5613 0
+20502300002
Fax 5613 0
Email 5613 0
hatem_ah@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