Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001025820
Ethics application status
Approved
Date submitted
21/09/2012
Date registered
24/09/2012
Date last updated
26/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The intrauterine insemination with stimulation in women with unexplained infertility study
Scientific title
An evaluation of the cumulative live birth rate from intrauterine insemination with stimulation in couples with unexplained infertility compared with expectant management.
Secondary ID [1] 281281 0
Nil
Universal Trial Number (UTN)
U1111-1134-9722
Trial acronym
TUI study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unexplained infertility 287486 0
Condition category
Condition code
Reproductive Health and Childbirth 287817 287817 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intrauterine insemination with stimulation. Women randomised to intrauterine insemination will undergo three cycles of stimulated intrauterine insemination (0.5ml of sperm suspension) Clomiphene citrate ovarian stimulation protocols will be used. Clomiphene citrate will be started orally on day 2 of the menstrual cycle for 5 days. The dose of clomiphene will be determined by the clinicians based on the woman's clinical indications. On day 12 an estradiol level and ultrasound scan (USS) will be performed. If there are more than 3 follicles present the IUI will not proceed and the patient will be informed not to be sexually active. If there are less than three follicles IUI will proceed when the blood tests indicate ovulation is about to occur (usually between day 12 and 16 of the cycle). A Tomcat catheter will be used for the IUI procedure. The inseminate will be prepared using a density gradient and spermatozoa will be re-suspended in 0.5 ml of human tubal fluid. The catheter will be passed through the cervical canal high up into the uterus and the specimen slowly injected. No luteal phase support will be given.
Intervention code [1] 285753 0
Treatment: Other
Intervention code [2] 285758 0
Treatment: Drugs
Comparator / control treatment
Expectant management. Couples assigned expectant management will be followed for three menstrual cycles from the time of randomisation. No additional treatment would occur during this time.
Control group
Active

Outcomes
Primary outcome [1] 288041 0
Cumulative live birth rate
Timepoint [1] 288041 0
40 weeks after each menstrual cycle (there are three cycles for each woman).
Secondary outcome [1] 299322 0
clinical pregnancies based on Quantitative B-hcg level Day 16 post procedure and an ultrasound at 6 weeks to evaluate whether there is a fetal heart.
Timepoint [1] 299322 0
6 weeks after each menstrual cycle (there are three cycles for each woman).
Secondary outcome [2] 299323 0
Ectopic pregnancy / miscarriage
Timepoint [2] 299323 0
In the 40 weeks after each menstrual cycle (there are three cycles for each woman).
Secondary outcome [3] 299324 0
Multiple pregnancy rates
Timepoint [3] 299324 0
At 6 weeks after each menstrual cycle (there are three cycles for each woman).
Secondary outcome [4] 299325 0
Ovarian hyper stimulation syndrome. This will be determined using ultrasound examinations and by measuring estradiol levels.
Timepoint [4] 299325 0
During each menstrual cycle (there are three cycles for each woman).

Eligibility
Key inclusion criteria
Unexplained infertility. Normal ovulation (or normal with ovarian stimulation). Patent fallopian tubes. Normal semen analysis (greater than or equal to 32% progressive motility, greater than or concentration equal to 15 million / ml or if the clinician believes they are a suitable candidate for IUI).
Minimum age
18 Years
Maximum age
42 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Doccumented tubal occlusion (bilateral or unilateral). Greater than three follicles on ultrasound (exclusion of the day of ultrasoun). Azoospermia. Women with anovulation secondary to polycystic ovarian syndrome.

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)
Women with unexplained infertility and a prediction score of <30% attending Fertility PLUS, Repromed of Fertility Associates and who wish to have IUI will be advised of the study and encouraged to take part. Power calculations were done based on Fertility PLUS clinical data. Those wishing to take part will be randomly allocated to either three cycles of IUI with stimulation or three cycles of expectant management. Randomisation will be done online, once the patients have been allocated there will be no blinding.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
When a patient decides to participate in the study her fertility provider will contact the co-investigator who will randomly allocate the patient to either the intervention or control group using a random number generator.
Masking / blinding
Open (masking not 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
12/03/2013
Actual
12/03/2013
Date of last participant enrolment
Anticipated
Actual
12/05/2016
Date of last data collection
Anticipated
Actual
18/04/2017
Sample size
Target
160
Accrual to date
Final
201
Recruitment outside Australia
Country [1] 4568 0
New Zealand
State/province [1] 4568 0

Funding & Sponsors
Funding source category [1] 288700 0
Charities/Societies/Foundations
Name [1] 288700 0
Maurice and Phyllis Paykel Trust.
Country [1] 288700 0
New Zealand
Funding source category [2] 288701 0
Charities/Societies/Foundations
Name [2] 288701 0
The Nurture Foundation
Country [2] 288701 0
New Zealand
Funding source category [3] 288702 0
Charities/Societies/Foundations
Name [3] 288702 0
Mercia Barnes Trust
Country [3] 288702 0
New Zealand
Funding source category [4] 288703 0
Charities/Societies/Foundations
Name [4] 288703 0
Evelyn Bond Trust
Country [4] 288703 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Faculty of Medical and Health Sciences
The University of Auckland
85 Park Rd
Grafton
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 284862 0
Individual
Name [1] 284862 0
Professor Cindy Farquhar
Address [1] 284862 0
Department of Obstetrics and Gynaecology and National Women's Health, Level 12, ACH Support Building, Auckland City Hospital,
Park Road, Grafton
Auckland 1020
Country [1] 284862 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288100 0
Health and Disability Ethics Committees
Ethics committee address [1] 288100 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 288100 0
New Zealand
Date submitted for ethics approval [1] 288100 0
27/09/2012
Approval date [1] 288100 0
02/11/2012
Ethics approval number [1] 288100 0

Summary
Brief summary
To evaluate whether the use of intrauterine insemination with ovarian stimulation with clomiphene citrate results in improved pregnancy and live birth rates compared with expectant management for couples with unexplained infertility and a prediction score for spontaneous fertility of less than 30%.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 852 852 0 0
/AnzctrAttachments/363068-TUI protocol for registration website_UPLOADED_160421.docx

Contacts
Principal investigator
Name 34746 0
Prof Cindy Farquhar
Address 34746 0
Department of Obstetrics and Gynaecology and National Women's Health,
University of Auckland,
Level 12, ACH Support Building,
Auckland City Hospital,
Park Road, Grafton
Private Bag 92019
Auckland 1020
NEW ZEALAND
Country 34746 0
New Zealand
Phone 34746 0
+64 9 3737599 EXT 89493
Fax 34746 0
Email 34746 0
[email protected]
Contact person for public queries
Name 17993 0
Prof Professor Cindy Farquhar
Address 17993 0
Department of Obstetrics and Gynaecology and National Women's Health, Level 12, ACH Support Building, Auckland City Hospital,
Park Road, Grafton
Auckland 1020
Country 17993 0
New Zealand
Phone 17993 0
+64 9 3737599 ext 89481
Fax 17993 0
Email 17993 0
[email protected]
Contact person for scientific queries
Name 8921 0
Prof Professor Cindy Farquhar
Address 8921 0
Department of Obstetrics and Gynaecology and National Women's Health, Level 12, ACH Support Building, Auckland City Hospital,
Park Road, Grafton
Auckland 1020
Country 8921 0
New Zealand
Phone 8921 0
+64 9 3737599 ext 89481
Fax 8921 0
Email 8921 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
SourceTitleYear of PublicationDOI
EmbaseIUI and IVF for unexplained subfertility: Where did we go wrong?.2016https://dx.doi.org/10.1093/humrep/dew241
EmbaseIntrauterine insemination with ovarian stimulation versus expectant management for unexplained infertility (TUI): a pragmatic, open-label, randomised, controlled, two-centre trial.2018https://dx.doi.org/10.1016/S0140-6736%2817%2932406-6
Dimensions AIIntrauterine insemination: a UK survey on the adherence to NICE clinical guidelines by fertility clinics2015https://doi.org/10.1136/bmjopen-2015-007588
N.B. These documents automatically identified may not have been verified by the study sponsor.