To take part in NHS trial?

[Alreadyxmas]

I'm currently TTC and I have PCOS, I have been offered a spot on the NHS LOCI trial.

I can start treatment as soon as tomorrow if I decide to take part but to be honest I'm trying to read the information and finding it really confusing. I've never heard of most of the terminology and I'm wondering if anyone could advise whether they'd do it or not.

From what I can gather the trial is To decide out of two medications called Letrozole Or Clomifene, which works best to induce ovulation.

YABU: No the consultant was just trying to sign you up (I think she's in charge of the trial) and you should just take the usual treatment. This would be clomifene.

YANBU: It sounds great and will hopefully help you to fall pregnant.

www.hra.nhs.uk/planning-and-improving-research/application-summaries/research-summaries/loci-letrozole-or-clomifene-for-ovulation-induction/

Ok so the summary is pretty well written. Standard treatment is successful 30% of the time. It’s not great - if it was a horse you wouldn’t back it would you?

You can opt into the trial & opt out at any time. It won’t affect your treatment, and you will likely get better treatment. By this, I mean you’ll get more interaction with your consultant. It’s just the way it is.

Statistically, clinical trial patients do ‘better’ than non trial patients from an emotional wellness POV & overall have better outcomes. I don’t have the reference for this coz it’s 7pm and I’m parenting RELENTLESSLY.

I’ve got no skin in this game BTW but it doesn’t seem like you have much to loose.

Yes one of the benefits is that you get constant monitoring which I'd have to pay a lot for as the usual treatment doesn't include scans and I'd have to pay for them.

I think you're right about there being nothing to lose

If you decline when would you start treatment and would you get metformin alongside the clomifene?
Do you want multiple children, and would you be entitled to further treatment if you successfully have a child?

The trials with or without metformin so OP might get it anyway.

Given current treatment isn't very successful I'd be seriously considering this. Have they given you a number or email if you have any questions? I don't know how NHS works for IVF, I'd want to know if you'd still be eligible for NHS IVF if the trial was unsuccessful. If you would be and you're not late 30s it will be a free extra shot at it and even if unsuccessful the extra monitoring could provide useful information.

Straight away if I pay for it and yes I believe so. Yes I would like multiple children so that's definitely something I should ask them, thank you

One has Metformin and the other has a placebo she says. But she didn't tell me what Metformin is.

This is my first time with any treatment, I haven't tried any yet so there are a few things to try before IVF is needed. I will definitely ask if I'm still able to receive other treatments if this one doesn't work. I'm late twenties so time is on my side but I would like a big family.

Late 20s it definitely seems worth it, if you're paying I'd assume you'd still be entitled to conventional treatment if it didn't work (but check).

If you were 40 and hoping for twins, maybe, maybe not.

Theres 4 groups - each drug with/without metformin. So 25% chance of worse treatment, but at your age you can likely afford 6 months for the 50% chance of probably better treatment.

hi OP, I work in clinical trials. Have you received the patient information sheet? I think it’s this one.

www.leicestermaternity.nhs.uk/EasysiteWeb/getresource.axd?AssetID=92226&type=full&servicetype=Attachment

PCOS sufferer here with a letrozole conceived DD. My specialist took me off clomifene and put me on letrozole. She said its more effective, fewer side effects and less risk of multiples!

I would def go for it! I also had metformin. PCOS can lead to insulin resistance (a bit like diabetes) - my very layperson understanding is that metformin helps to stabilise blood sugar levels and reverses some of the effects of PCOS.

I had monitoring - all very straightforward and helps know when best to time sex to be successful.

Sounds like a great trial! Wish i could get back on it for no 2!! 🤣

I don’t want to sway your decision, but after 4 years of TTC and no reason lack of ovulation( I didn’t have PCOS) I was offered a space on this trial. I had spent several months working on myself holistically prior to seeking medical help, acupuncture, healthy diet, no alcohol,exercise and acupressure mats- physically my body was primed- I started the loci trial in September 22 and fell pregnant on my first cycle. The only side effect I had was the metaformin/placebo I couldn’t take 3x as instructed and had to go back down to 1 per day as it upset my stomach. I’d say go for it- you’ve got to be in it to win it, we had every back up ready if we didn’t succeed, IUI, IVF and adoption

Metformin is intended to help with blood sugar levels - I have taken it. The idea is that you lose weigh. I didn’t.
some women find it difficult to tolerate to it’s usually recommended to build up gradually.

@Alreadyxmas what have you decided? X

Wow thank you for the success story and congratulations!! I started the pills on Monday, wish me luck

Sorry I haven't been on here! I decided to go ahead and give it a go. I was given provera to induce a period which started on Monday, so I started the medication Tuesday. Instructions say to have sex 2/3 times a week starting from day 8 of the cycle. I'm hopeful but still trying to remain realistic!

I would definitely consider it, hopefully it will lead to a successful outcome for you, and for other women in the future once the work has been done. And they should hopefully monitor you and look after you well- even if you are in a placebo group.

@Alreadyxmas this is fab news! Wishing you all the luck, please do keep this thread up to date 🥰 x

Thank you! I will do, so far so good and no side effects x

Yes very good luck 🤞

if they are the clinic are tracking your follicle maturation they may tell you to go home and “go at it” as much as possible every day for a 7 day spell. That’s what they did for me, they scanned me every 48-72 hours when the follicle really ramped up maturation speed and said the more “wee men” are in the Fallopian tubes waiting for the egg to be released the better as the egg is only viable for 12-24 hours sometimes even less. It worked for us- my partner was a champ even though he was Ill that week and still managed an early morning and evening “session”. Best of luck xxxx

Sounds exhausting! So glad it worked for you. I'm going for a scan on Tuesday but I'm not actually sure what they're scanning for, definitely need to ask more questions when I go back x

They’ll do a transvaginal and measure your endometrium lining and measure any follicles, once a dominant follicle is identified they will track it over the next week+ to give you an estimate when/if you’ll ovulate. This will help them gauge if the dosage that your on is correct or if they need to increase the dose in your next cycle. You should receive a blood test later on to check your progesterone level. I never exceeded 3.0 Progesterone before and after these meds I measured 55.4 which indicated ovulation. Best of luck xxxx

That's exactly what happened! All a bit confusing to me but they said the follicle is looking good and they'll check again in a few days. Thank you xx

👋 hey! I’m hopefully starting this trial soon. I went for a scan and blood tests (and an impromptu smear) yesterday so just waiting on those results before I get started. How’s it going for you?

I’m 18w1d with my little girl. Best of luck when you start the trial, keep us up to date in your progress and any Q’s just ask away xx