What clinical trials are currently underway?
The PCOSMIC Trial (PolyCystic Ovary Syndrome – Metformin for Infertility with Clomiphene)
Strictly, the PCOSMIC Trial was undertaken by REACT-NZ, the New Zealand multi-centre forerunner of REACT-ANZ. This study is a randomised controlled trial, in women with polycystic ovary syndrome, looking at the effectiveness of metformin and clomiphene citrate for anovulatory infertility.
The aim of the trial is to determine whether fertility is improved by adding metformin to standard management for anovulatory PCOS. (Standard treatment for this in New Zealand has traditionally been clomiphene citrate for women with BMI ≤32 and lifestyle intervention alone for women with BMI >32.) The trial will also provide pilot data regarding which is the most effective treatment for women with BMI ≤32: metformin, clomiphene citrate or both.
We recruited and randomised 171 women: follow up data will be analysed and presented in This trial has now been completed, and has been presented at FSA 2008, ESHRE 2009, RANZCOG 2009 and AOCOG (Asia Oceania Congress of O&G) 2009
Please contact Associate Professor Neil Johnson (n.johnson@auckland.ac.nz) for further information.
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Fallopian Sperm Perfusion Study
This study is a randomised controlled trial of fallopian sperm perfusion (FSP) versus intrauterine insemination (IUI). The aim of FSP is to try to get more sperm into the fallopian tubes rather than just into the uterus. Intrauterine insemination is a simple, non-invasive, cost-effective technique used for couples with unexplained infertility. IUI is usually combined with fertility drugs such as clomiphene citrate that help women to produce more than one egg per cycle, increasing the chance of pregnancy. The aim of IUI is to inject a small amount of prepared semen (usually from the male partner) directly into the uterus via a catheter. The procedure enables sperm to bypass the cervix which can contain dense mucous that blocks the semen from moving into the uterus. Sperm are then able to swim up to meet the egg in the fallopian tube, where fertilization occurs in natural conception.
The aim of Fallopian Sperm Perfusion is to get sperm into the fallopian tubes rather than just into the uterus. To achieve this, FSP uses more sperm (4mls compared with 0.5mls in IUI) and a catheter with a balloon preventing back flow of the semen. With FSP sperm actually reaches the fallopian tube and fertilization is able to take place in the tube, which is what happens with spontaneous conceptions.
Professor Cindy Farquhar is leading this randomized controlled trial at the University of Auckland and is being assisted by Dr Bruno Radesic and Dr Ginny Griffiths. Women who provide consent are randomly allocated to either IUI or FSP. At this stage, over 100 women have been recruited into the study. Five other centers are also recruiting for this study – three New Zealand fertility clinics (Fertility Plus, Repromed NZ (Auckland) and Fertility Associates (Auckland)), two Australian fertility clinics (Repromed Adelaide, and Greenslopes Specialist Center) and one clinic in the United Arab Emirates. The researchers are aiming to recruit over 400 women in the next year.
If you are interested in taking part in this study please contact Cindy Farquhar:
Ph: 021 995 414
Email: c.farquhar@auckland.ac.nz