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Trial registered on ANZCTR


Registration number
ACTRN12612000731897
Ethics application status
Approved
Date submitted
14/06/2012
Date registered
9/07/2012
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Different treatment modalities for women with polycystic ovary like phenotype undergoing assisted reproduction
Scientific title
A randomized controlled trial of Hp-hMG versus recombinant FSH for women with polycystic ovary like phenotype undergoing ART, comparing the number of intermediate-sized follicles (15-17 mm) between groups.
Secondary ID [1] 280678 0
nil
Universal Trial Number (UTN)
U1111-1130-7284
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
polycystic ovary like phenotype 286703 0
infertility. 286855 0
Condition category
Condition code
Reproductive Health and Childbirth 287002 287002 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: highly purified HMG;
Arm2: recombinant FSH
HP-hMG administered by intramuscular (i.m.) injections, rFSH subcutaneausly,
patients underwent controlled ovarian hyperstimulation following down-regulation with a gnrh agonist in a long protocol. leuprolide acetate, 1mg /days subcutaneausly (lucrine; abbott) was initiated 5-7 days before the estimated start of next menses and continued as 0.5 mg/days until end of gonadotropin administration. gonadotropin administration was initiated when down-regulation was confirmed by using transvaginal ultrasound showing no ovarian cysts, and endometrium with a thickness of <5 mm or serum estradiol <50 pg/ml. the starting dose of HP-hMG or rFSH was 150 iu for the first three days, followed by according to the patient’s follicular response. choriongonadotropin alfa, 250 microgram subcutaneausly (ovitrelle; serono), was administered within a day of observing three or more follicles of greather than or equal to18 mm diameter to induce final follicular maturation.
Intervention code [1] 285085 0
Treatment: Drugs
Comparator / control treatment
gonadotropin administration was initiated when down-regulation was confirmed by using transvaginal ultrasound showing no ovarian cysts, and endometrium with a thickness of <5 mm or serum estradiol <50 pg/ml. the starting dose of rFSH was 150 iu for the first three days, followed by according to the patient’s follicular response. choriongonadotropin alfa, 250 microgram (ovitrelle; serono), was administered subcutaneausly within a day of observing three or more follicles of greather than or equal to18 mm diameter to induce final follicular maturation.
Control group
Active

Outcomes
Primary outcome [1] 287334 0
Primary Outcome 1: comparison of the number of intermediate-sized follicles (15-17 mm) assessed by using transvaginal ultrasound between HP-hMG and rFSH in PCO patients undergoing ICSI.
Timepoint [1] 287334 0
Timepoint: at 2 weeks after randomisation
Secondary outcome [1] 297928 0
Secondary Outcome 1: : peak estradiol (E2) level assessed by serum assay
Timepoint [1] 297928 0
Timepoint:at 2 weeks after randomisation
Secondary outcome [2] 298209 0
number of retrieved oocytes, time of hCG administration assessed by using ultrasound
Timepoint [2] 298209 0
Timepoint:at 2 weeks after randomisation
Secondary outcome [3] 298210 0
total gonadotropin dose administered and
duration of gonadotropin treatment,
Timepoint [3] 298210 0
Timepoint:at 2 weeks after randomisation
Secondary outcome [4] 298211 0
number of patients who had coast days (Coasting is withholding gonadotrophins until estradiol level falls to a safe level before giving hCG)
Timepoint [4] 298211 0
Timepoint:at 2 weeks after randomisation
Secondary outcome [5] 298212 0
number of ovarian hyperstimulation syndrome (OHSS) characterized by cystic enlargement of the ovaries and a fluid shift from the intravascular to the third space due to increased capillary permeability diagnosed by clinical and ultrasound findings
Timepoint [5] 298212 0
Timepoint:at 4 weeks after randomisation
Secondary outcome [6] 298213 0
clinical pregnancy rate assessed by blood hcg levels and ultrasound,
Timepoint [6] 298213 0
Timepoint:six weeks after randomisation
Secondary outcome [7] 298214 0
live birth rate
Timepoint [7] 298214 0
Timepoint:at one year after randomisation
Secondary outcome [8] 298240 0
endometrial thickness at the time of hCG administration assessed by using ultrasound
Timepoint [8] 298240 0
Timepoint:at 2 weeks after randomisation

Eligibility
Key inclusion criteria
Group of infertile women aged 18-39 years who manifest sonographic evidence of polycystic ovarian morphology (POM) but who do not have any clinical manifestation of the polycystic ovarian syndrome (PCOS)
Minimum age
18 Years
Maximum age
39 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
early follicular phase serum FSH levels less than or equal to 12 IU/l and abnormal levels of prolactin and partners with semen abnormalities requiring TESE.

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)
Patients were randomised using a computer-assisted 1:1 randomization to undergo ovarian stimulation with either HP- hMG or rFSH, no blinding procedure was adopted toward both patients and doctors. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients were randomised using a computer-assisted 1:1 randomization to undergo ovarian stimulation with either HP- hMG or rFSH, no blinding procedure was adopted toward both patients and doctors
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 4365 0
Turkey
State/province [1] 4365 0
Ankara

Funding & Sponsors
Funding source category [1] 285576 0
Self funded/Unfunded
Name [1] 285576 0
Country [1] 285576 0
Primary sponsor type
Individual
Name
Sertac Batioglu
Address
Zekai Tahir Burak Women’s
Health Research and Education Hospital, Talatpasa Bulvari Hamamonu 06230, Ankara
Country
Turkey
Secondary sponsor category [1] 284290 0
None
Name [1] 284290 0
Address [1] 284290 0
Country [1] 284290 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287452 0
Local Ethics Committee of the Zekai Tahir Burak Women's Health Research and Education Hospital
Ethics committee address [1] 287452 0
Ethics committee country [1] 287452 0
Turkey
Date submitted for ethics approval [1] 287452 0
23/02/2009
Approval date [1] 287452 0
02/03/2009
Ethics approval number [1] 287452 0
12

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34316 0
Address 34316 0
Country 34316 0
Phone 34316 0
Fax 34316 0
Email 34316 0
Contact person for public queries
Name 17563 0
Ruya Deveer
Address 17563 0
30. CAD. 340. SK. Mutlu Apt. 5/5
Cigdem Mah.- Cankaya Ankara
06680
Country 17563 0
Turkey
Phone 17563 0
+905063801350
Fax 17563 0
Email 17563 0
deveer3@hotmail.com
Contact person for scientific queries
Name 8491 0
Ruya Deveer
Address 8491 0
30. CAD. 340. SK. Mutlu Apt. 5/5
Cigdem Mah.- Cankaya Ankara
06680
Country 8491 0
Turkey
Phone 8491 0
+905063801350
Fax 8491 0
Email 8491 0
deveer3@hotmail.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.