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What will be involved?

*The following protocol is similar to the one used in clinical practice for those undergoing IVF treatment for fertility

You will be asked to start a medication called Lupron, via subcutaneous injection, 10 days after a positive ovulation test (urine test kits that will be sent home with you after your consultation). The purpose is to prevent the luteinizing hormone surge (LH) that causes you to ovulate (much like taking birth control for one month only). You will come back 10-14 days later for an ultrasound, blood draw, and then begin using an estrogen supplement. The estrogen supplement is to mimic the estrogen your body would normally be producing at this time during your cycle.

After another 10-14 days, you will do another ultrasound and blood draw. You will add the third and final medication, which is progesterone via intramuscular injection. Progesterone is another hormone your body would normally be producing at this time. We are simply controlling the dose to later detect its effect on the morphology of the endometrial lining. You will take progesterone once a day for 10 days, during which time you will schedule 4 timed blood draws. On the final day, you will have a final blood draw, give a urine sample, and undergo an endometrial biopsy (small 2-8mm sample of the lining of your uterus; the same lining you would normally shed during menstruation). This procedure generally lasts 5-10 minutes. Common side effects associated with this procedure can be described as menstrual cramps during moment of biopsy, and vaginal bleeding/spotting may occur after the procedure. The severity of these side effects vary among individuals. A good reference for details on the endometrial biopsy can be found here.

How long will this study take?

This research study takes 7-8 weeks to complete, with a total of 8-10 visits to our clinic at UNC. All appointments take between 20min-1hr, and all parking will be paid for to those who need it. You will have the option of returning after two menstrual cycles for a follow-up endometrial biopsy. You will receive $500 and then $200 if you choose to return for the follow-up biopsy.

What are risks?

Typical side effects vary depending on the individual. Possible, but rare side effects include fatigue and can be similar to PMS-like symptoms. These will generally subside after starting estrogen supplementation. Side effects associated with the estrogen patch include possible irritation in the area of the patch. Since Lupron is given via a subcutaneous injection, side effects may include bruising in the injection area. Progestrone is given through intramuscular injections, and side effects may include soreness in the area of administration.

The image below shows the body’s natural hormone fluctuation during your normal menstrual cycle, so you can see how the schedule of hormone replacement is similar to physiological hormone patterns.

hormone

Will this affect me later, when the study is over?

This is very unlikely. Much like taking birth control pills, once you discontinue the Lupron and hormone supplements, your body will “re-set.” Very quickly your hormone levels will return to normal, you will begin ovulating and start menstruating. Your ability to become pregnant in the future will not be affected by this protocol.

Please feel free to contact us if you have any additional questions.