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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Ms
Georgia
Mitchell
+44 (0)121 4146665
g.mitchell.1@bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Polycystic ovarian syndrome
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Polycystic ovary syndrome (PCOS) affects 20% of women. Women with PCOS may not release eggs from their ovaries; this is called anovulation. The first line treatment for anovulation is a medicine called clomifene (formerly known as clomiphene). Current clinical guidelines in the UK recommend the use of clomifene with or without another medicine, metformin, for a maximum of 6 menstrual cycles. Clomifene treatment does not result in pregnancy for approximately 70% of women despite prolonged treatment. Furthermore, clomifene is associated with numerous side effects and a 10-fold increase in the risk of multiple pregnancy.
Recently there has been growing interest in the use of another medicine, letrozole, to treat infertility in women with PCOS. Letrozole works differently to clomifene and has fewer side effects, including a lower risk of multiple pregnancy. A recent review of studies involving all available medicines for women with PCOS and infertility has indicated that letrozole may be more effective than clomifene when used alone, and there may be additional value when it is combined with metformin.
This trial has been developed in consultation with two patient representation groups, Fertility Network UK and the Women’s Network of the RCOG.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
Current inclusion criteria as of 17/10/2022:
1. Women diagnosed with PCOS (according to Rotterdam criteria) and evidence of anovulation (defined as irregular cycles lasting <21 or >35 days, fewer than 8 periods per year, or absence of raised serum progesterone >20 nmol/l seven days prior to a period)
2. Presentation with infertility or wishing to conceive
3. Male partner with normal sperm count (≥15 million/ml) and progressive motility ≥32% or total motility ≥40% in the last 3 years
4. Willing and able to give informed consent
5. Aged ≥18 to ≤42 years at randomisation
6. Body Mass Index
You may not be able to take part if:
Current exclusion criteria as of 17/10/2022:1. More than six previous ovulation induction treatments (cycles) with either letrozole or clomifene in the previous 12 months2. Intention to continue current use of metformin treatment for ovulation induction or for other indications3. Metformin use in the previous 14 days4. Women opting for alternative methods of ovulation induction or treatment (GnRH agonists and antagonists, gonadotropins), triggering ovulation with hCG, or performing intrauterine or intracervical insemination5. Contraindications to letrozole, clomifene, metformin use and/or pregnancy 6. Woman has previously participated in the LOCI trial_____
Previous exclusion criteria:1. Age <18 or >43 years at randomisation2. Body Mass Index ≥35 kg/m²3. Three or more previous ovulation induction treatments with either letrozole or clomifene4. Currently on metformin treatment or inositol supplements for ovulation induction or for other indications 5. Women opting for alternative methods of ovulation induction or treatment (GnRH agonists and antagonists, gonadotropins), triggering ovulation with hCG, or performing intrauterine or intracervical insemination6. Contraindications to letrozole, clomifene, metformin use and/or pregnancy (see section 7.2 for full details on contraindications)7. Woman has previously participated in the LOCI trial
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Georgia
Mitchell
+44 (0)121 4146665
g.mitchell.1@bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Birmingham and funded by NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 17/116/01; National Institute for Health Research (NIHR) (UK).
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 42795
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