The Fertility and IVF and IUI trial in couples with uneXplained infertility

Nau mai, Haere Mai

We invite you to take part in a clinical study being run across all fertility clinics in Aotearoa New Zealand to find out what the best treatment option is for couples with unexplained infertility to become pregnant

Kia ora!
The FIIX Study has now finished recruitment.
A special thank you to all whānau/couples who agreed to participate in the study!

The FIIX Study is a clinical trial comparing the two main fertility procedures available through public funding in Aotearoa New Zealand – The Fertility and In Vitro Fertilisation (IVF) and Intra Uterine Insemination (IUI) trial in couples with uneXplained infertility.

Whānau/couples with unexplained infertility who have been accepted for publicly funded fertility treatment are suitable to participate.

Intrauterine insemination (IUI) involves the placement of prepared sperm into the uterus, often using ovulation induction medication. It is a less invasive procedure than IVF. We suspect that IUI will result in the same number of whānautanga (birth) as IVF.

By doing this research we hope to provide more opportunities for whānau/couples with unexplained infertility to become pregnant.

Benefits of the study

You may begin treatment earlier – whānau/couples with unexplained infertility currently wait up to 15 months before their treatment commences, this time may be reduced if you participate.
For those assigned to the IUI group, if pregnancy is achieved then you avoid the more invasive IVF procedure.
Whānau/couples who agree to participate in The FIIX Study will not incur any costs. Their treatment will be publicly funded.

Participating fertility clinics

If you agree take to part in this study, you will remain in the fertility clinic you have already been allocated to for publicly funded fertility treatment. These clinics are:

Fertility PLUS – Tāmaki Makaurau/ Auckland
Repromed – Tāmaki Makaurau/ Auckland
Fertility Associates – Tāmaki Makaurau/Auckland, Hamilton, Wellington, Christchurch

For Fertility PLUS and Repromed clinics, contact us: TheFIIXstudy@auckland.ac.nz or 09 923 1281.

For all Fertility Associates clinics, contact: npathirana@fa.co.nz or 0800 323 449.

Background literature

Bensdorp AJ et al. Prevention of multiple pregnancies in couples with unexplained or mild male subfertility: randomised controlled trial of in vitro fertilisation with single embryo transfer or in vitro fertilisation in modified natural cycle compared with intrauterine insemination. BMJ 2015;350:g7771.
Custers IM et al. Couples with unexplained subfertility and unfavorable prognosis: a randomized pilot trial comparing the effectiveness of in vitro fertilization with elective single embryo transfer versus intrauterine insemination with controlled ovarian stimulation. Fertility and Sterility 2017;96(5):1107-1111.
Nandi A et al. Intrauterine insemination with gonadotropin stimulation or in vitro fertilization for the treatment of unexplained subfertility: a randomized controlled trial. Fertility and Sterility 2017;107:0015-0282.
Farquhar CM et al. Intrauterine insemination with clomiphene citrate versus expectant management for unexplained infertility: a pragmatic open-label, randomised, controlled, two-centre trial. Lancet 2017;3;391(10119):441-450.

Download the FIIX participant information sheet

Download the FIIX study information brochure

Download the FIIX study protocol

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theFIIXstudy@auckland.ac.nz

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09 923 81281

Contact us

Meet our rōpū- the FIIX team

From left to right: Melissa Vercoe (Trial coordinator); Dr Lynn Sadler (Epidemiologist); Dr Lucy Prentice (Trial manager); Professor Cindy Farquhar (Principal investigator)

Read what some of our participants had to say

Starting a family has always been a priority for my husband and I after marriage. After trying for years, we explored alternative fertility options and were referred to the FIIX Study.

With limited fertility knowledge, the study provided us with simple and user friendly information and service and made us feel at ease to discuss something which in the Pacific culture is sensitive and socially not talked about openly.

Throughout our fertility journey on the FIIX Study, the staff on the phone, in the clinic and in our virtual appointments were very personable, knowledgeable and made the IUI fertility process comfortable.

The Study has blessed our lives and will forever be part of our family journey. We are now very happy parents of a baby boy, who continues to fulfil us both and completes us. Such a blessing of life is invaluable especially given its positive impact on parents, like us, who have longed to start a family.

We both highly recommend the FIIX Study for those couples who are undergoing similary fertility challenges. Thank you to the FIIX Study staff and support people. You have truly made our dreams a reality!

Anonymous

We were told about the FIIX Study by our Fertility doctor.

We have had previous private treatment: six IUIs, a poppy seed oil tubal flushing and lots of blood tests/ investigations over the 5 years.

We were randomised into the IVF group in the FIIX Study. We had one cycle of IVF which made five embryos and on our 3rd frozen embryo cycle, we got pregnant. We now have a beautiful baby girl who is so worth the wait.

We feel so lucky to have been part of this research and that it worked for us. We didn’t ever just feel like a number or a research participant, our care and support from the clinic was great and we felt informed every step of the way. Infertility is tough and slow, and every little positive thing that comes your way (such as funded research treatment) should be grabbed onto with both hands.

Kathryn and Navin

I heard about the study through my GP, and from the very beginning I knew this could give us a chance to get pregnant. We were going to enquire with a private fertility clinic but something deep inside told us we had to give this a chance first.

The study helped us enormously, we had been randomly chosen to start IUI and even if, at first, we thought it was going to be more challenging and less likely to get pregnant this way, the staff at FIIX supported us strongly and gave us the confidence we needed to go thorough it.

I completed the first IUI and got pregnant but miscarried at week 10. This is when I started losing hope and if it hadn’t been for the amazing support of the doctors and nurses, we would have given up. I even had a counsellor from the study calling me and asking me how I was dealing with the loss. This was very important for my recovery.

In the third round of IUI I fell pregnant again and this time it was a successful pregnancy. The staff at FIIX followed me up until week 11 and then I continued my journey with a private Obstetrics.

I couldn’t recommend this study enough. We wouldn’t have a beautiful daughter today if it hadn’t been for their amazing help and support. We will be forever grateful to the team and the chance we had been given to make our deepest dream come true.

Yanina and Gabriel

We found out about the FIIX study through our family doctor.

After 6 + years of trying to concieve naturally and failing over and over again, we were able to be referred to the FIIX study group. Our doctor said all our tests came fine and they couldn’t explain why we were consitently miscarrrying. We had never done any private treatment prior to the FIIX study programe.

FIIX helped ease our minds and have hope that there was still a chance of having a baby. The staff was amazing and so considerate of our circumstance. Our journey from day 1 in the FIIX study programme was amazing and I talk about it with my friends and collegues who are absolutely amazed by the FIIX study programme.

Although the first round of IVF treatment failed, the second round was finally successful and we were finally able to have a baby (with 2 embryos still in storage). Our beautiful baby boys was born in December 2022.

The FIIX study is an amazing opportunity for couples that are struggling. You don’t get to choose which treatment you go on (IUI or IVF). The system chooses for each couple. It doesn’t matter though because 1) the treatment is funded and 2) the FIIX study team is so respectful and supportive throughout the whole programme.

We are truly thankful for the FIIX study and glad that our doctor referred us. We came out the other end with a beautiful baby boy and 2 more frozen embryos currently stored.

Tiave and Fraser

We first heard about the FIIX study in October 2021, via an email inviting us to take part in the study. At the time, my husband and I were on the waiting list, meaning another 12-18months before any treatment could start. Joining the FIIX study, allowed us to start treatment earlier.

We were randomised to the IUI group and began our treatment in February 2022. As someone who has dealt with negative pregnancy tests for over 5 years, we were finally blessed to see a positive pregnancy test the following month. 36 weeks into our pregnancy we welcomed our beautiful baby girl in October.

Infertility is a long and difficult journey and as a couple who has been approached to participate in this study, we would highly recommend it. It’s amazing to know that there are programs and treatments available for couples experiencing infertility. These treatments have given us the opportunity to become parents.

Anonymous

It was the end and the beginning of sorts. I believe FIIX is the only reason we have a daughter now. We had been trying to conceive for about 8 years before applying for public help or seeking help from a fertility clinic.

FIIX was the end of waiting. I was going to need to wait until May 2020 for our first public fertility consult. The study meant we could have a consult at the end of January and start treatment in February 2020. This was significant because I was 38 and nearing the cut off age for public assistance.

In the end we were incredibly lucky and FIIX was the beginning of many more beginnings. The world had to stop for me to have my wee miracle and I’m forever thankful for FIIX.

For anyone considering it, I would highly recommend it. For anyone running out of time, finances or even emotional strength, FIIX can help. Anyone who has unexplained fertility issues and qualifies for public assistance has been on a long journey.

The hardest part of treatment can be egg collections. I recommend if you are successful to ask for a picture of the blastocyst. It makes the process seem real and it’s fascinating to see how we all start out as a whole little bunch of cells. We can’t wait to share it with my daughter when she is old enough to understand and show her how perfect she was from the very beginning.

Anonymous

How did you hear about the FIIX study?

I was contacted by the co-ordinators of the study.

How did the FIIX study help you in your conception journey?

It helped tremendously. It gave us a chance to fast track our IVF journey.

When did FIIX enter in your journey ? Did you start with FIIX/ had private treatment before?

We started with FIIX.

What was the outcome of your participation in the study ?

We had a beautiful baby girl last year in February and recently celebrated her first birthday.

What would you tell a couple who is considering joining the study ?

Join it as soon as you can!

Ashwita and Simon

Approved by Central Health and Disability Ethics Committee on 15 April 2019, reference code 19/CEN/40.