Melbourne IVF heavily invests a great deal of time and resources into clinical research in our aim to provide our patients access to the most advanced science in fertility investigation and treatment. We are proud of our leadership within the fertility profession and our clinicians, nurses and scientists are all committed to the future of fertility treatment.
Current Clinical Research Projects
IVF with Preimplantation Genetic Screening using Next Generation Sequencing (STAR Trial)
Recruitment for the world-wide multi-centre study, designed to evaluate if biopsy and genetic testing of an embryo (PGS) results in a better outcome than the standard method of selecting an embryo, based on its appearance (morphology) and ability to grow to the blastocyst stage, is now complete. Results from the trial are currently being collated and will be published once available.
The Melbourne IVF PGD laboratory was selected to participate due to their international reputation as a world leader in PGD, and was the only IVF unit in the southern hemisphere to participate in this world-wide clinical trial.
We anticipate the information gathered will help assess whether PGS using the Next Generation Sequencing (NGS) platform improves success rates on the IVF program.
Nifedipine for improving Implantation and Pregnancy rates in ART Trial (NIPA)
Implantation failure is the main factor affecting the success rate of IVF procedures. Excessive uterine contractions have been described as a potential mechanism for reduced implantation rates in IVF cycles.
Uterine contractions are stimulated by the embryo transfer procedure and by ovarian stimulation itself. It is thought that contractile activity of the uterus could move the implanted embryo towards the Fallopian tubes or cervix/vagina, or the embryo might even be expelled out of the uterus. It is thought that such contractions could play a role in IVF patients who have undergone several cycles that failed to result in pregnancy. Therefore, a reduction in contractions in the uterus on the day of embryo transfer may increase the chance of pregnancy in IVF patients. The entry of calcium is critical for the transfer of the electrical signal that passes from muscle cell to muscle cell, and signals the cells to contract. Calcium channel blockers are drugs that block the entry of calcium into the muscle cells, thereby reducing muscle contractility.
Melbourne IVF is undertaking a clinical trial to investigate if a compound named nifedipine (which is a calcium channel blocker) may be able to reduce the frequency of contractions in the uterus and assist with the implantation of the embryo.
This trial will be suitable for women who are undergoing a fresh IVF/ICSI cycle with a fresh embryo (fertilised egg) transfer. Find out how to participate…
The 'POP Study' (Pregnancy Outcomes after Pre-conception weight loss)
Research has shown women who carry excess weight prior to pregnancy are more likely to have trouble conceiving. Once pregnant, these women have higher rates of gestational diabetes and gestational hypertension/pre-eclampsia. They are also more likely to deliver by Caesarean section. Babies born to women carrying excess weight are at an increased risk of premature delivery and being born either small or large for gestational age. They are also more likely to require additional care after delivery.
If you are keen to lose weight prior to pregnancy, you are invited to consider participation in a clinical trial being conducted by the University of Melbourne. The ‘POP Study’ aims to explore how much weight loss is required by an obese woman in order to optimise pregnancy outcomes for mother and baby. Women who participate in this study will be randomized to one of two different weight loss programs. These programs will occur under the supervision of medical doctors, dieticians and nurses with vast experience in weight management.Women will then be observed during the pre-pregnancy, pregnancy and early post-natal stages of pregnancy and information about the health of mother and baby will be collected.
In order to be involved in this trial, you must be:
- Female aged 18-38 years old
- Body Mass Index (BMI) 30-50 kg/m2
- Desiring weight loss prior to pregnancy
- Considering pregnancy but not planning to become pregnant within the next 3 months, regardless of the method of conception
- Living in Victoria, Australia
Acupuncture is one of the most commonly used complementary therapies for women trying to get pregnant either naturally or through fertility treatment. As such, acupuncture is an area of interest to Melbourne IVF as we would like to see evidence of the effectiveness of claims made in previous studies.
Recruitment for the national multi-centre randomised controlled acupuncture trial to determine if acupuncture improves live birth rates for women undergoing IVF is now complete. Results from the trial are currently being collated and will be published once available.
Understanding women's experiences of egg freezing
Melbourne IVF, in collaboration with The Jean Hailes Research Unit at Monash University and the Department of Obstetrics and Gynaecology at The University of Melbourne, is undertaking a study exploring the experiences of women who have frozen their eggs for non-medical reasons. The study aims to help improve our understanding of women’s needs for fertility-related services and clinical care related to egg freezing
Patients who have frozen their eggs through Melbourne IVF for social reasons over the past 15 years are invited to complete an anonymous questionnaire. To participate in the study please contact the Melbourne IVF Clinical Research Department on (03) 9473 4570.
Read more about the announcement of the social egg freeze study...
The LIGHT study: Assessing the effect of recombinant human growth hormone (r-hGH) on live birth rates in women who are poor responders undergoing an IVF/ICSI cycle
The aim of this Australian multi-centre collaborative study is to determine the influence of growth hormone treatment as an adjunct to stimulation with the maximal dose of FSH stimulation in the unexpected poor responding IVF patient - patients requiring maximal dose of stimulation despite being under 41 years of age. This randomised, double blind placebo controlled study is now complete with results expected by October 2015.
Use of transdermal testosterone cream in IVF pre-treatment and its effect on controlled ovarian stimulation and IVF outcome in poor responder IVF patients: a randomised placebo-controlled trial
Poor ovarian response to ovarian stimulation usually indicates a reduction in follicular response, resulting in a reduced number of retrieved oocytes (eggs). Consequentially, poor ovarian response results in fewer embryos, reduced implantation rate, decreased pregnancy rates and high cycle cancellation rates. Although several approaches have been considered for the management of poor responders, this remains a challenging issue.
We are therefore initiating a randomised, double blind, placebo controlled Trial, which will investigate the effectiveness of transdermal testosterone cream, delivering a dose of testosterone that restores levels within the normal female range, in improving ovarian response and thus the live birth rate in known poor responders undergoing IVF/ICSI. Women aged less than 43 and who have had a previous poor response will be considered for participation. Find out how to participate..
Ovarian follicular fluid Melatonin levels and ovarian reserve
Melatonin is made by the ovary, in addition to other organs. It is thought that the melatonin level in ovarian follicular fluid drops with increasing age and decreasing ovarian reserve. As a pilot study, we aim to establish a relationship between lower follicular fluid melatonin and increasing age, as well as ovarian reserve and egg quality. Find out how to participate..
Preservation of Spermatogonia in mature human testicular tissue
Since pre-pubertal boys cannot benefit from sperm banking, a potential alternative for preservation of their fertility involves storage of testicular tissue in the hope that future technologies will allow its safe utilisation.
This study aims to establish:
- The preservation and proliferation capacity of residual spermatagonia in testicular tissue.
- The preservation and proliferation capacity of residual spermatagonia in testicular tissue following xenografting.
- The preservation and proliferation capacity of residual spermatagonia in testicular tissue following cryopreservation.
Identification of Genomic Determinants of Uterine Receptivity
Successful establishment of pregnancy requires a viable embryo and a receptive uterus. Over the past 30 years there have been many IVF-related advances in embryology that have resulted in significant improvements in embryo viability and overall success rates,; however, over the same time, understanding of uterine receptivity in humans has advanced little. We are therefore undertaking a prospective, controlled study which will aim to identify determinants of uterine receptivity by studying the gene expression of the human endometrium at the time of embryo implantation. With our collaborator Grant Montgomery from the QLD Institute of Medical Research, genes showing evidence for a functional role in uterine receptivity will be identified. Find out how to participate..
Banking on the future: Establishing evidence for policy, protocols and patient care relating to storage of reproductive material before treatment for cancer.
In recent decades there have been rapid technological advances in cryopreserving sperm, oocytes (eggs), embryos, and ovarian tissue as a means of enabling future genetic parenthood for cancer survivors. Simultaneously, increasing survival after cancer in childhood and young adulthood means that demand for cryopreservation and subsequent fertility treatment is growing.
This project aims to investigate and describe the development of expert practice in fertility preservation associated with cancer treatment to inform Australian guidelines and policies. It is the hope that these will inform recommendations for national policy development and service strengthening. The case study will demonstrate our position as a leading organisation not only in techniques and practices, but also as a public-spirited contributor to national guidelines and policies. Find out how to participate..
Follow-up of children conceived through use of donor sperm.
A questionnaire based study, the project aims to assess the physical, psychosocial and development of children conceived through use of donor sperm, between 2004 and 2007. Analysis will be over the period 2004 -2007 as that is within the school age of those who accessed donor sperm and conceived in 2000 (when medical donor sperm was granted). Find out how to participate..
Health and well-being of PGD children at school age compared with IVF conceived and spontaneously conceived children of the same age.
Children of school age are being recruited from three groups: those conceived through IVF (without PGD), those conceived through IVF (with PGD), and those spontaneously conceived.
This project aims to investigate the health and well-being of children conceived following PGD. A questionnaire will be administered which will aim to determine the health and well-being of these children as well as parental bonding. Find out how to participate..
Evaluation of written information and a decision tool for deciding what to do with unused embryos.
Many people who have excess embryos in storage often struggle to make a decision about what the fate of the embryos should be once their storage life has expired. Existing evidence shows that deciding what to do with unused frozen embryos can be very difficult and that patients want clinics to provide them with information and support through the process of arriving at a decision. As part of the trend to provide patient centred care, decision aids are increasingly being used to assist people facing decisions relating to treatment of a range of medical conditions. This project therefore aims to develop a tool which can be applied to assist people in clarifying their thoughts about the available embryo disposition options and to reach a decision that is best for them. Find out how to participate..
A multi-clinic prospective study of participants engaging in a Victorian altruistic surrogacy program.
In January 2010 the legislation allowed for altruistic surrogacy arrangements to be offered in accredited IVF units. To ensure our approach to this program is holistic, supportive and addresses the concerns of all parties involved, we have initiated a study where, from the initiation of the surrogacy arrangement, with all parties involved – commissioning woman and commissioning man, surrogate and her partner (if applicable) and egg donor (if applicable) – until the infant is six months, we will aim to better understand attachment styles, how relationships are affected, as well as understand relinquishment issues for surrogates and commissioning couples. Find out how to participate..
Xenografting of human ovarian tissue as a model for clinical auto grafting
For almost 10 years we have been offering women with malignant disease the option to cryopreserve ovarian tissue prior to commencing cytotoxic therapy which may render them infertile. In parallel with a small number of groups around the world, we have now started to graft frozen tissue back into selected patients. Although some early reports of positive outcomes have appeared, there is little knowledge regarding the factors critical for successful autografting.
The aim of this study is to investigate the early events which occur following grafting using a xenografting model and to determine whether manipulation of the grafting environment can restrict cell or tissue loss. Find out how to participate..
Participating in clinical trials
Melbourne IVF has a well-resourced Clinical Research Department that operates according to ICH-GCP standards.
In addition to our own research, sometimes research is undertaken in collaboration with other research institutes. On occasion, patients may be invited to participate in research. It is important to note that research activities which require patient participation has been considered and approved by a Human Research and Ethics Committee which operates according to the National Statement on Ethical Conduct in Human Research (2007) produced by the National Health and Medical Research Council of Australia. This statement has been developed to protect the interests of people who agree to participate in human research studies.
What is a clinical trial?
Clinical trials are research studies designed to address important questions in fertility research. The results of these trials help doctors find ways to improve patient outcomes. Each study allows us to answer scientific questions, to find better ways to treat or help patients and to evaluate the effectiveness of emerging fertility treatments and procedures.
Why participate in a clinical trial?
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
- Play a more active role in their own health care,
- Obtain expert medical care at leading health care facilities during a trial,
- Gain access to new research treatments before they are widely available, and
- Help others by contributing to medical research.
Who can participate in a clinical trial?
All clinical trials have inclusion and exclusion criteria; these guidelines describe who can participate and are based on factors such as age, gender, previous treatments, medical history and other medical conditions. Before joining a clinical trial participants must meet eligibility criteria. For all types of trials, the participants work with the Research Team.
The Research Team checks the health of the participant at the beginning of the trial, gives specific instructions for participating in the trial, monitors the participant carefully during the trial, and stays in touch after the trial is completed.
To help someone decide whether or not to participate in a trial, the researchers involved explain the details of the study, such as the purpose, duration and required procedures, and provide details of key contacts. Risks and potential benefits are explained in an Informed Consent document. The participant then decides whether or not to sign this consent form; this is not a contract, and you may withdraw from the trial at any time. Withdrawing from a trial does not influence your treatment or relationship with Melbourne IVF in any way.
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice are very stringent and also apply to clinical trials.
Every clinical trial must be approved and monitored by an independent Human Research Ethics Committee (HREC), which is registered with The National Health and Medical Research Council. The HREC evaluates all trials very comprehensively to make sure patient safety is assured, the risks are as low as possible and patient rights and interests are protected. An HREC is an independent committee of physicians, statisticians, community advocates and others. Its primary focus is to ensure that clinical trials are ethical and safe.
As a clinical trial progresses, researchers report the results of the trial at scientific meetings which maybe national or international, to medical journals, and to various government agencies. Individual participants’ names remain confidential and are not disclosedin these reports.
If you are interested in participating in a clinical trial, or would like to find out more about our research program, we encourage you to contact our Research Team direct.