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Trial registered on ANZCTR


Registration number
ACTRN12619001003167
Ethics application status
Approved
Date submitted
2/07/2019
Date registered
15/07/2019
Date last updated
15/04/2024
Date data sharing statement initially provided
15/07/2019
Date results information initially provided
15/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Fertility In Vitro Fertilisation (IVF) and Intrauterine Insemination (IUI) trial in couples with uneXplained infertility (The FIIX Study).
Scientific title
Effect of IVF compared to Intrauterine Insemination on live birth rate in couples with uneXplained infertility (The FIIX Study).
Secondary ID [1] 298453 0
None
Universal Trial Number (UTN)
U1111-1229-2553
Trial acronym
The FIIX Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unexplained Infertility 313197 0
Condition category
Condition code
Reproductive Health and Childbirth 311657 311657 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intrauterine insemination (IUI) followed by in vitro fertilisation (IVF) arm

Participants randomised to this arm will receive four cycles of IUI, followed by two completed cycles of IVF until pregnancy leading to live birth is achieved.
IUI treatment will begin at the start of the next menstrual cycle (day 1) following randomisation. IUI with oral ovarian stimulation will be given with five days of either oral clomiphene citrate (CC) or letrozole from cycle day 2-6. The clinicians and fertility clinics involved will determine the medication used and dose as per their normal clinic policy. The dose of Clomiphene is usually between 25mg-150mg daily and letrozole 2.5-7.5mg daily. Blood tests will be taken, and monitoring for follicular development via transvaginal ultrasound will occur, according to clinic protocol, this usually will not be more than 2-3 times per cycle. On the day of ovulation semen will be washed and prepared and then directly inserted with a catheter into the cervix.
The IUI procedure will be carried out either by a fertility clinic nurse trained in IUI or by the study co-ordinator (myself) a fertility subspecialty trainee. It will be carried out at the fertility clinics involved in the study.
If four cycles of IUI are carried out and do not lead to live birth then the patient progresses to IVF treatment.
The number of cancelled and complete cycles of IUI that have been carried out, and over what time period, will be monitored by our Data Safety Monitoring Board (DSMB) and reported back to the trial steering committee if there are concerns. Four cycles of IUI would be expected to be complete within the primary endpoint (six/seven months from the date of randomisation).

IVF will be carried out by doctors, embryologists and nurses at the involved clinics in the standard way the clinic normal carries out an IVF cycle. The study is pragmatic in that the clinic and practitioner has autonomy over the cycle type, medication dose and follow up/progress regimen. Two completed cycles of IVF will be offered until a live birth is achieved. A completed cycle includes transfer of all available frozen embryos in subsequent cycles, using a single embryo transfer policy. All frozen embryos must be transferred prior to progressing into the second IVF cycle. The two IVF cycles would be expected to be complete within a 12/13 month time frame.
Intervention code [1] 314699 0
Treatment: Other
Intervention code [2] 314939 0
Treatment: Drugs
Comparator / control treatment
In vitro fertilisation (IVF) arm.

Participants randomised to this arm will receive up to two completed cycles of IVF until pregnancy leading to live birth is achieved. The first cycle of IVF will run parallel to the IUI cycles in the intervention arm and we would aim to complete this cycle within the primary endpoint (six/seven months from randomisation) (including frozen embryo transfers). Both cycles should be complete by 20 months post randomisation with follow up not extending beyond 24 months.

IVF will be carried out by doctors, embryologists and nurses at the involved clinics in the standard way the clinic normal carries out an IVF cycle. The study is pragmatic in that the clinic and practitioner has autonomy over the cycle type, medication dose and follow up/progress regimen. Two completed cycles of IVF will be offered until a live birth is achieved. A completed cycle includes transfer of all available frozen embryos in subsequent cycles, using a single embryo transfer policy. All frozen embryos must be transferred prior to progressing into the second IVF cycle.
Control group
Active

Outcomes
Primary outcome [1] 320363 0
Cumulative live birth rate (CLBR), defined as any live birth conceived within 185/215 days (6/7 months) of randomisation, including live birth following a treatment cycle (including any subsequent frozen embryo replacements) and following any spontaneous pregnancy or pregnancy from off protocol treatment. Conception will be determined by a positive serum pregnancy test. Live birth is defined as birth after 20 completed weeks of gestation of a baby which breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 400 grams or more can be used if gestational age is unknown. Live births are counted as birth events, for example, a twin or triplet live birth is counted as one birth event.
Timepoint [1] 320363 0
Measured at 185 days (six months) for participants randomised prior to and including 18th August 2021.
Measured at 210 days (seven months) for participants randomised after 18th August 2021.
Secondary outcome [1] 371350 0
CLBR defined as any conception leading to live birth measured at 550/610 days (18/20 months) from randomisation regardless of whether all potential treatment cycles are completed. Conception will be determined by a positive serum pregnancy test. Live birth is defined as the complete expulsion or extraction from a woman of a product of fertilization, after 20 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles, irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown. Live births refer to the individual newborn; for example, a twin delivery represents two live births.
Timepoint [1] 371350 0
Measured at 550days/18months (for participants randomised prior to and including 18th August 2021).
Measured at 610days/20months (for participants randomised after 18th August 2021).
Any pregnancies from off protocol treatments, and spontaneous pregnancies, will be counted.
Secondary outcome [2] 371351 0
CLBR at the completion of four IUI-OS cycles or one complete IVF cycle. Conception will be determined by a positive serum pregnancy test. Live birth is defined as the complete expulsion or extraction from a woman of a product of fertilization, after 20 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles,irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown. Live births refer to the individual newborn; for example, a twin delivery represents two live births.
Timepoint [2] 371351 0
At the completion of four cycles of IUI-OS (after fourth cycle serum pregnancy test) or one complete IVF cycle but no later than 12 months (365 days) following randomisation.
Secondary outcome [3] 371353 0
CLBR at the completion of all treatment cycles

Conception will be determined by a positive serum pregnancy test.
Live birth is defined as the complete expulsion or extraction from a woman of a product of fertilization, after 20 completed weeks of gestational age; which, after such separation, breathes or shows any other evidence of life, such as heart beat, umbilical cord pulsation or definite movement of voluntary muscles,irrespective of whether the umbilical cord has been cut or the placenta is attached. A birth weight of 500 grams or more can be used if gestational age is unknown. Live births refer to the individual newborn; for example, a twin delivery represents two live births.
Timepoint [3] 371353 0
At the completion of all allocated or required treatment but no later than 24 months (730 days) following randomisation.
Secondary outcome [4] 371354 0
Time to pregnancy leading to live birth: defined as the time taken to conceive a pregnancy which results in a live birth, measured as calendar time from randomisation to pregnancy.
Timepoint [4] 371354 0
No fixed time point, measured in days, maximum will be 24 months (730 days)
Secondary outcome [5] 371355 0
Number of frozen embryos remaining at completion of treatment
Timepoint [5] 371355 0
18 months (550 days) for participants randomised prior to and including 18th August 2021
20 months (610 days) for participants randomised after 18th August 2021.
Secondary outcome [6] 371356 0
Ongoing pregnancy; defined as the presence of a heart beat as seen by ultrasonography 12 weeks after last menstrual period or treatment cycle start (including singleton, twin pregnancy, and higher multiples).
Timepoint [6] 371356 0
6 months (185 days) and 18 months (550 days) for participants randomised <=18/08/2021
7 months (210 days) and 20 months (610 days) for participants randomised >18/08/2021
Secondary outcome [7] 371357 0
Viable pregnancy; defined as an intrauterine pregnancy diagnosed by ultrasonography of at least one fetus with a discernible heartbeat.
Timepoint [7] 371357 0
6 months (185 days) and 18 months (550 days) for participants randomised <=18/08/2021
7 months (210 days) and 20 months (610 days) for participants randomised >18/08/2021
Secondary outcome [8] 371358 0
Miscarriage; the spontaneous loss of an intrauterine pregnancy with fetal heart beat prior to 20 completed weeks of gestational age.
Timepoint [8] 371358 0
6 months (185 days) and 18 months (550 days) for participants randomised <=18/08/2021
7 months (210 days) and 20 months (610 days) for participants randomised >18/08/2021
Secondary outcome [9] 371359 0
Ectopic pregnancy; defined as a pregnancy outside the uterine cavity, diagnosed by ultrasound, surgical visualisation or histopathology.
Timepoint [9] 371359 0
6 months (185 days) and 18 months (550 days) for participants randomised <=18/08/2021
7 months (210 days) and 20 months (610 days) for participants randomised >18/08/2021
Secondary outcome [10] 371360 0
Stillbirth; defined as the death of a fetus prior to the complete expulsion or extraction from its mother after 20 completed weeks of gestational age. The death is determined by the fact that, after such separation, the fetus does not breathe or show any other evidence of life, such as heartbeat, umbilical cord pulsation, or definite movement of voluntary muscles. Note: this includes deaths occurring during labour.
Timepoint [10] 371360 0
6 months (185 days) and 18 months (550 days) for participants randomised <=18/08/2021
7 months (210 days) and 20 months (610 days) for participants randomised >18/08/2021
Secondary outcome [11] 371361 0
Termination of pregnancy/ induced abortion; intentional loss of an intrauterine pregnancy, through intervention by medical, surgical or unspecified means.
Timepoint [11] 371361 0
6 months (185 days) and 18 months (550 days) for participants randomised <=18/08/2021
7 months (210 days) and 20 months (610 days) for participants randomised >18/08/2021
Secondary outcome [12] 372019 0
FertiQOL (treatment related) questionnaire
Timepoint [12] 372019 0
6 months (185 days) and 18 months (550 days) for participants randomised <=18/08/2021
7 months (210 days) and 20 months (610 days) for participants randomised >18/08/2021
Secondary outcome [13] 372020 0
Hospital admission for ovarian hyperstimulation syndrome that included drainage of ascites or pleural effusions - serious adverse events
Defined as any admission to hospital where the working diagnosis is OHSS and drainage of ascites or a pleural effusion was required. This will be determined by the individual fertility clinic searching hospital records or identifying the discharge summary diagnosis for patients.
Timepoint [13] 372020 0
6 months (185 days) and 18 months (550 days) for participants randomised <=18/08/2021
7 months (210 days) and 20 months (610 days) for participants randomised >18/08/2021
Secondary outcome [14] 372021 0
Hospital admission from other treatment-related causes such as OHSS, haemorrhage, or pelvic infection requiring active treatment - serious adverse events.
This excludes hospital admissions for pregnancy/obstetric related complications (e.g. admission for ectopic/miscarriage/pre-eclampsia/PPROM/postpartum complications etc.)
Timepoint [14] 372021 0
6 months (185 days) and 18 months (550 days) for participants randomised <=18/08/2021
7 months (210 days) and 20 months (610 days) for participants randomised >18/08/2021
Secondary outcome [15] 372022 0
Multiple pregnancy; defined as two or more gestational sacs seen by ultrasonography.
Timepoint [15] 372022 0
6 months (185 days) and 18 months (550 days) for participants randomised <=18/08/2021
7 months (210 days) and 20 months (610 days) for participants randomised >18/08/2021
Secondary outcome [16] 372104 0
Incremental cost per couple.
Unit costs will include - medication cost of the drugs in the only public clinic (Fertility Plus); intervention services (IUI and IVF) using 2020 costs as paid to the Northern Region clinics; pregnancy and delivery for singletons and multiple pregnancy sourced from the medical literature 9-11 or current birth costs in New Zealand.
Timepoint [16] 372104 0
6 months (185 days) and 18 months (550 days) for participants randomised <=18/08/2021
7 months (210 days) and 20 months (610 days) for participants randomised >18/08/2021
Secondary outcome [17] 372105 0
Incremental cost per live birth.
Unit costs will include - medication cost of the drugs in the only public clinic (Fertility Plus); intervention services (IUI and IVF) using 2020 costs as paid to the Northern Region clinics; pregnancy and delivery for singletons and multiple pregnancy sourced from the medical literature 9-11 or current birth costs in New Zealand.
Timepoint [17] 372105 0
6 months (185 days) and 18 months (550 days) for participants randomised <=18/08/2021
7 months (210 days) and 20 months (610 days) for participants randomised >18/08/2021
Secondary outcome [18] 380853 0
biochemical pregnancy - defined as a pregnancy diagnosed only by the detection of beta hCG in serum or urine, which fails to progress to the point of ultrasound confirmation.
Timepoint [18] 380853 0
6 months (185 days) and 18 months (550 days) for participants randomised <=18/08/2021
7 months (210 days) and 20 months (610 days) for participants randomised >18/08/2021
Secondary outcome [19] 380855 0
Early pregnancy loss - defined as the spontaneous loss of an intrauterine pregnancy, where there is no fetal heart beat detected at the time of ultrasound at 6-8 weeks.
Timepoint [19] 380855 0
6 months (185 days) and 18 months (550 days) for participants randomised <=18/08/2021
7 months (210 days) and 20 months (610 days) for participants randomised >18/08/2021
Secondary outcome [20] 401435 0
Serious drug reaction as a result of medication taken during fertility treatment - serious adverse events
Timepoint [20] 401435 0
6 months (185 days) and 18 months (550 days) for participants randomised <=18/08/2021
7 months (210 days) and 20 months (610 days) for participants randomised >18/08/2021
Secondary outcome [21] 401436 0
Maternal death at any point during study follow-up, including pregnancy and 6 weeks postnatal - serious adverse events
Timepoint [21] 401436 0
6 months (185 days) and 18 months (550 days) for participants randomised <=18/08/2021
7 months (210 days) and 20 months (610 days) for participants randomised >18/08/2021
Secondary outcome [22] 434081 0
Major congenital anomaly identified within 6 weeks of birth - serious adverse events
Defined as requiring admission to NICU due to abnormality (such as, complex cardiac/congenital diaphragmatic hernia) after birth or palliative care.
Timepoint [22] 434081 0
Secondary outcome [23] 434082 0
Major congenital anomaly identified within 6 weeks of birth - serious adverse events
Defined as requiring admission to NICU due to abnormality (such as, complex cardiac/congenital diaphragmatic hernia) after birth or palliative care.
Timepoint [23] 434082 0
No fixed time point, within six weeks of birth, maximum will be 24 months (730 days) post randomisation.
Secondary outcome [24] 434083 0
Neonatal death occurring within 6 weeks of delivery - serious adverse events
Timepoint [24] 434083 0
No fixed time point, within six weeks of birth, maximum will be 24 months (730 days) post randomisation.
Secondary outcome [25] 434084 0
Neonatal death occurring within 6 weeks of delivery - serious adverse events
Timepoint [25] 434084 0
No fixed time point, within six weeks of birth, maximum will be 24 months (730 days) post randomisation.

Eligibility
Key inclusion criteria
Inclusion criteria
1. Eligible for two packages of publicly funded fertility treatment in NZ and all of the following:
a. Age - Female <39 years 4 months and male <54 years and 4months at the time of randomisation.
b. Body mass index (BMI) - Female - BMI < /= 32.
c. Both partners are non-smokers for three months.
d. Both partners with no history of illicit drug use or alcohol abuse within the preceding 12 months.
e. Day 2 FSH <15IU for the female partner
f. Both partners must be a NZ citizen or resident, hold a NZ work visa or student visa which allows them to stay in NZ continuously for two years or more, or be an Australian citizen or resident who can prove intention to stay in NZ for two years or more.
g. Couples must have:
i. No previous children from public fertility treatment.
ii. No more than one child (including adopted children) of any age to the same relationship, or
iii. No more than one child from a previous relationship living at home (at least half of the time)
2. Female partner has a regular ovulatory cycle (21-35 days).
3. Female partner has evidence of patent fallopian tube(s) on hysterosalpingogram or at laparoscopy or recent intrauterine miscarriage (within 24 months) (tubal spasm is not considered tubal blockage).
4. Male partner has a total motile sperm count (TMSC) > 10 million, on last semen analysis or within two of the past three semen analyses.
Minimum age
18 Years
Maximum age
54 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women with a history of stage 3 and 4 endometriosis
2. Women with submucosal fibroids or any fibroid >8cm or fibroids between 5-8cm if endometrial cavity is distorted or cavity length is >10cm.
3. Couple who require egg or sperm donation
4. Women with a past history of ectopic pregnancy or bilateral blocked tubes or tubal surgery for adhesions/hydrosalpinges.

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)
Yes there is allocation concealment.
Allocation concealment will be ensured, as the data system will not release the randomisation code until the couple has been recruited into the trial, which takes place after baseline measurements have been entered in the system.
The randomisation sequence will not be accessible to the recruiters.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Couples will be randomly assigned to either the IUI followed by IVF arm or the IVF arm with a 1:1 allocation using a variable block design via a web-based data system.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Couples will be randomly assigned to either the IUI followed by IVF arm or the IVF arm with a 1:1 allocation using a variable block design via a web-based data system. The block sizes will not be disclosed, to ensure concealment.
Allocation concealment will be ensured, as the data system will not release the randomisation code until the couple has been recruited into the trial, which takes place after baseline measurements have been entered in the system.
The randomisation sequence will not be accessible to the recruiters. The study is not blinded because of the nature of the intervention. The researchers who collect data for pregnancy outcomes will be aware of the assigned intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Primary outcome (CLBR at 6 months if randomised <=18/08/2021; CLBR at 7 months if randomised >18/08/2021):
Primary analysis of CLBR will be conducted using logistic regression. The outcome of any ongoing pregnancies at 6/7 months post randomisation will be included. This will be adjusted for the stratification variables: age and centre. For the purpose of comparison with the non-inferiority margin, a risk difference will be obtained from the fitted model, by predicting risk under both allocations for each patient. A bootstrap procedure will be used to calculate the 95% confidence interval, which will be used to test the hypothesis of non-inferiority.

Secondary outcomes:
For continuous and binary outcomes, linear and logistic regression will be employed, adjusting for the stratification variables. For time to pregnancy leading to live birth, a Cox regression model will be used, and cumulative incidence will be plotted.

Subgroup analyses:
Exploratory subgroup analyses for CLBR will be performed, but the trial is not powered to this end. These will involve tests of interaction between treatment and age (<36 vs 36 or over) and between treatment and number of previous treatment attempts. These analyses will be considered hypothesis generating.

Sensitivity analyses:
Sensitivity analyses will be conducted around the missing data assumptions used in the analysis of the primary outcome (see section, Missing outcome data).

Additional analyses:
An analysis will be conducted to estimate the treatment effect adjusting for protocol violations, which includes use of off-protocol treatment and treatment switches to the other arm (anticipated to generally be in the direction IUI to IVF). This will involve censoring participants at the point of violation and performing an inverse probability of censoring weighed analysis. The covariates to include in this model will be discussed with the TSC and updated, but are anticipated to include age, site, and a prognostic score.

Safety data:
Serious adverse events will be analysed descriptively, by treatment group.

Some participants will have their treatment in the study interrupted or delayed due to the COVID-19 pandemic. These participants will be retained in the analysis.

Recruitment
Recruitment status
Active, not recruiting
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] 21598 0
New Zealand
State/province [1] 21598 0

Funding & Sponsors
Funding source category [1] 302999 0
Government body
Name [1] 302999 0
Northern Regional Fertility Service
Country [1] 302999 0
New Zealand
Funding source category [2] 303152 0
Charities/Societies/Foundations
Name [2] 303152 0
Auckland DHB Charitable Trust (A+ Research Grant)
Country [2] 303152 0
New Zealand
Funding source category [3] 303153 0
Charities/Societies/Foundations
Name [3] 303153 0
Auckland Medical Research Foundation
Country [3] 303153 0
New Zealand
Funding source category [4] 309791 0
Charities/Societies/Foundations
Name [4] 309791 0
Mercia Barnes
Country [4] 309791 0
New Zealand
Funding source category [5] 309792 0
Charities/Societies/Foundations
Name [5] 309792 0
Maurice and Phyllis Paykel Trust
Country [5] 309792 0
New Zealand
Funding source category [6] 309793 0
Government body
Name [6] 309793 0
Health Research Council
Country [6] 309793 0
New Zealand
Funding source category [7] 316312 0
Government body
Name [7] 316312 0
Te Puna Tahua Lottery Grants Board
Country [7] 316312 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 302998 0
None
Name [1] 302998 0
Address [1] 302998 0
Country [1] 302998 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303548 0
Health and Disability Ethics Committee
Ethics committee address [1] 303548 0
Health and Disability Ethics Committees
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 303548 0
New Zealand
Date submitted for ethics approval [1] 303548 0
08/03/2019
Approval date [1] 303548 0
15/04/2019
Ethics approval number [1] 303548 0
NZ/1/CB42113

Summary
Brief summary
The FIIX study is a randomised controlled trial that will be carried out across NZ involving couples with unexplained infertility who are eligible for public funding. They will receive either four intrauterine insemination (IUI) cycles (washed sperm placed into the uterus) or one in vitro fertilisation (IVF) cycle (embryos made in the laboratory by mixing eggs with sperm) to determine if the treatments have similar live birth rates (LBR). The trial will continue to completion of public treatment for these couple (which is two IVF cycles) and compare LBR and cost at the end. Our hypothesis is that for couples with unexplained infertility, (1) four cycles of IUI is comparable to one completed cycle of IVF for CLBR and is more cost effective; and (2) four cycles of IUI followed by two cycles of IVF will result in more live births at lower total cost than two cycles of IVF alone.
Trial website
thefiixstudy.auckland.ac.nz
Trial related presentations / publications
Public notes
The Central Health and Disability Ethics Committee approval of amendment was received 18/02/2022 (Ethics reference: 2022 AM 8410), and in agreement with the FIIX Study Data Monitoring and Safety Committee in February 2022.

Amendment: Extend the primary endpoint from 185 to 215 days, and secondary endpoint from 550 to 610 days for all future participants and those randomised after 18th August 2021 as a result of delay in completion of treatment cycles in both arms of the trial which was evident before, and exacerbated by, Covid-19.

Justification: Covid-19 and the effects of nationwide lockdowns have had a significant impact on recruitment, randomisation, and provision of trial treatments in this study. In order to provide a meaningful comparison of the two arms of the study at the primary and secondary endpoints we need a good percentage of participants to have completed their treatment within this time frame. By extending this time by one month it allows for disruptions to treatment provision outside of the study control.

Contacts
Principal investigator
Name 94046 0
Prof Cindy Farquhar
Address 94046 0
Department of Obstetrics and Gynaecology
University of Auckland
Level 12 Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
New Zealand
Country 94046 0
New Zealand
Phone 94046 0
+6421995414
Fax 94046 0
Email 94046 0
c.farquhar@auckland.ac.nz
Contact person for public queries
Name 94047 0
Dr Lucy Prentice
Address 94047 0
Department of Obstetrics and Gynaecology
University of Auckland
Level 12 Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
New Zealand
Country 94047 0
New Zealand
Phone 94047 0
+64 2102497362
Fax 94047 0
Email 94047 0
lucy.prentice@auckland.ac.nz
Contact person for scientific queries
Name 94048 0
Dr Lucy Prentice
Address 94048 0
Department of Obstetrics and Gynaecology
University of Auckland
Level 12 Auckland City Hospital
2 Park Road
Grafton
Auckland 1023
New Zealand
Country 94048 0
New Zealand
Phone 94048 0
+64 2102497362
Fax 94048 0
Email 94048 0
lucy.prentice@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
no consent for this


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocolPrentice L, Sadler L, Lensen S, Vercoe M, Wilkinson J, Edlin R, Chambers GM, Farquhar CM. IVF and IUI in couples with unexplained infertility (FIIX study): study protocol of a non-inferiority randomized controlled trial. Hum Reprod Open. 2020 Sep 22;2020(3):hoaa037. doi: 10.1093/hropen/hoaa037. PMID: 32995562; PMCID: PMC7508023.   377747-(Uploaded-29-09-2022-12-06-01)-Study-related document.pdf
Informed consent form    377747-(Uploaded-13-06-2019-13-00-36)-Study-related document.docx
Ethical approval    377747-(Uploaded-01-07-2019-18-02-00)-Study-related document.pdf
Ethical approval    Copy of all HDEC letters of ethic approval from 15... [More Details] 377747-(Uploaded-29-09-2022-12-09-48)-Study-related document.pdf


Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseIVF and IUI in couples with unexplained infertility (FIIX study): Study protocol of a non-inferiority randomized controlled trial.2020https://dx.doi.org/10.1093/HROPEN/HOAA037
N.B. These documents automatically identified may not have been verified by the study sponsor.