Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000153819
Ethics application status
Approved
Date submitted
31/01/2012
Date registered
3/02/2012
Date last updated
3/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Ganirelix in insemination cycles of women with premature luteinization
Scientific title
The effect of gonadotropin-releasing hormone antagonist in unsuccessful controlled ovarian stimulation and intrauterine insemination cycles with premature luteinization
Secondary ID [1] 279848 0
Nill
Universal Trial Number (UTN)
U1111-1127-5468
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infertility 285718 0
intrauterine insemination 285732 0
Condition category
Condition code
Reproductive Health and Childbirth 285903 285903 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Recombinant FSH (rFSH) treatment with a starting dose of 50-75 IU per day was commenced by the day 3 of menstrual cycle
a) according to low dose step-up protocol (Speroff L, Fritz MA (2005). Assisted reproductive technologies. In Clinical Gynecologic Endocrinology and Infertility, 7th ed., pp. 1216–1274)
b) by a once daily subcutaneous injection in the abdominal wall, injected by the patient using pen
c) until the follicle diameter reach 20 mm (usually within 7-14 days)
From day 7 onwards, the gonadotropin dose was adjusted and individualized based on the follicular growth observed by ultrasonography.
Ganirelix, GnRH antagonist, was administered
a) at the dose of 0.25 mg per day starting from the day in which a follicle > 14 mm in mean diameter was visualized at ultrasound scan (flexible multiple dose protocol)
b) by subcutanous injection
c) till the follicle reaches 18 mm (usually within 4-5 days)
Intervention code [1] 284157 0
Treatment: Drugs
Comparator / control treatment
Recombinant FSH (rFSH) treatment with a starting dose of 50-75 IU per day was commenced by the day 3 of menstrual cycle
a) according to low dose step-up protocol (Speroff L, Fritz MA (2005). Assisted reproductive technologies. In Clinical Gynecologic Endocrinology and Infertility, 7th ed., pp. 1216–1274)
b) by a once daily subcutaneous injection in the abdominal wall, injected by the patient using pen
c) until the follicle diameter reach 20 mm (usually within 7-14 days)
From day 7 onwards, the gonadotropin dose was adjusted and individualized based on the follicular growth observed by ultrasonography.
Control group
Active

Outcomes
Primary outcome [1] 286395 0
Two weeks after the intrauterine insemination procedure, an hCG assay was performed. If the assay was positive, transvaginal ultrasonography was scheduled for 2-3 weeks later.
Only a positive hCG was determined as biochemical pregnancy, both positive hCG assay and determination of embriyonic heartbeat was accepted as clinical pregnancy. Ultrasonography was done at 12-16th week to establish ongoing pregnancy.
Timepoint [1] 286395 0
two years period from June 2007
Two weeks after the intrauterine insemination procedure, an hCG assay was performed.
Ultrasonography was done at 12-16th week to establish ongoing pregnancy
Secondary outcome [1] 295774 0
Luteinizing hormone (LH) levels > 10 IU/L and progesterone (PRG) levels > 1 ng/ml was considered as premature luteinization.
PRG level was determined by competitive electro-chemoluminescent immunoassay method by auto-analyzer. LH levels were determined by sandwich electro-chemoluminescent immunoassay method by the same autoanalyzer.
Timepoint [1] 295774 0
two years period from June 2007
LH and PRG levels were determined 10-14 days after menstruation

Eligibility
Key inclusion criteria
The main inclusion criteria were age between 18 and 38 years, primary or secondary infertility lasting for > 12 months, normal thyroid function, normal prolactin levels and normal uterine cavity and bilateral tubal patency assessed by hysterosalpingography
Minimum age
18 Years
Maximum age
38 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
severe male factor infertility (sperm concentration <10 x106 or strict morphology <4%), stage III or IVendometriosis, baseline FSH > 10 IU/L.

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
114
Accrual to date
Final
Recruitment outside Australia
Country [1] 4097 0
Turkey
State/province [1] 4097 0

Funding & Sponsors
Funding source category [1] 284606 0
Self funded/Unfunded
Name [1] 284606 0
Country [1] 284606 0
Turkey
Primary sponsor type
University
Name
Mersin University
Address
Mersin University School of Medicine Department of Obstetrics and Gynecology
Zeytinlibahce
Mersin
33079
Country
Turkey
Secondary sponsor category [1] 283534 0
None
Name [1] 283534 0
Address [1] 283534 0
Country [1] 283534 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286601 0
Mersin University Ethical Committee
Ethics committee address [1] 286601 0
Mersin University School of Medicine Department of Obstetrics and Gynecology
Zeytinlibahce
Mersin
33079
Ethics committee country [1] 286601 0
Turkey
Date submitted for ethics approval [1] 286601 0
Approval date [1] 286601 0
23/03/2007
Ethics approval number [1] 286601 0

Summary
Brief summary
To observe the effects of ganirelix on controlled ovarian stimulation and intrauterine insemination (COS/IUI) cycles in women who had premature luteinization (PL) in their first failed cycles.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33707 0
Address 33707 0
Country 33707 0
Phone 33707 0
Fax 33707 0
Email 33707 0
Contact person for public queries
Name 16954 0
Devrim Ertunc
Address 16954 0
Mersin University
School of Medicine
Department of Obstetrics and Gynecology
Zeytinlibahce
Mersin
33079
Country 16954 0
Turkey
Phone 16954 0
+90,324,3374300
Fax 16954 0
+90,324,3374305
Email 16954 0
[email protected]
Contact person for scientific queries
Name 7882 0
Devrim Ertunc
Address 7882 0
Mersin University
School of Medicine
Department of Obstetrics and Gynecology
Zeytinlibahce
Mersin
33079
Country 7882 0
Turkey
Phone 7882 0
+90,324,3374300
Fax 7882 0
+90,324,3374305
Email 7882 0
[email protected]

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.