Difficulties in getting pregnant

Difficulties in getting pregnant 

The ULTRA study is being carried out by several European centres in order to evaluate an innovative medical device developed by May Health for the treatment of infertility in women suffering from Polycystic Ovary Syndrome (PCOS), also called Stein-Leventhal syndrome.

PCOS is a hormonal imbalance which leads to the appearance of various symptoms (acne, excessive hair growth, excess weight) which may vary from one person to another. Patients generally have larger ovaries than other women and a high number of ovarian follicles, generally accompanied by the lack or absence of ovulation which causes infertility (inability to get pregnant). More than 1 woman in 10 suffers from this syndrome.

Several treatments exist to stimulate ovulation using drugs. They are not always effective and may have side effects. In addition, they do not treat the other symptoms linked with PCOS. The May Health procedure has been developed to help PCOS patients to experience a more natural and less medicalised ability to become pregnant

It has been shown that the reduction in volume of the ovaries may contribute to restoring the hormone balance which enables natural ovulation to be re-established. The May Health solution has been developed to reduce the volume of the ovaries by means of a short procedure taking less than 1 hour, without a general anaesthetic. The procedure is carried out only once and uses a non-surgical minimally invasive technique, via the vagina, similar to IVF (In-Vitro Fertilisation).

The patient is positionned on the table, lightly sedated. The medical device, looking like a long needle is installed on a transvaginal ultrasound probe. The ultrasound probe is inserted into the patient’s vagina to allow ultrasound visualisation of the ovaries. Once in proximity with one of the ovaries, the needle is inserted, and a small catheter is deployed. The tissue to be destroyed is heated by the catheter for a a minute at a time, in several places within the ovary. The procedure may be repeated on the second ovary. The catheter and needle are then withdrawn and the patient would be able to go home after a few hours.

Who may take part in this clinical study?

You are eligible for the ULTRA study if:

• You are aged between 18 and 40 years 
• You have been diagnosed with Polycystic Ovary Syndrome (PCOS) by a health professional
• You plan to get pregnant and are encountering difficulties in getting pregnant 
• You have tried an initial ovarian stimulation treatment (Clomiphene citrate or Letrozole) without success: you did not ovulate at least during your last 2 cycles. You are in a couple relationship with a man who has no fertility problems

What will happen if you decide to participate in this clinical study?

If you take part in this clinical study, you will have to come to the hospital for several monitoring visit over a total period of 24 months (see image schedule below). 

• The first visit will confirm your inclusion in the clinical study. Examinations will be carried out: blood test, vaginal ultrasound scan and physical examination
• The procedure will be carried out at the second visit
• You will then be asked to come back each week for up to 12 consecutive weeks to carry out a blood test to verify whether your natural ovulations are reappearing.
• At three and six months after the procedure, you will have to come back to the hospital to undergo the same examinations as at your first visit in order to compare the results
• During your participation, telephone calls with the medical team will be scheduled.

You will benefit from the following:

• The procedure and monitoring examinations of the clinical study, free of charge

• You will be closely monitored throughout the clinical study by a centre with expertise in infertility linked to PCOS

   

• Your travelling expenses will be reimbursed.

• You will participate in PCOS awareness/ advancing science for you and or other women affected by PCOS

How to participate?

If you wish to participate in this clinical study, please register on this internet site by filling in the questionnaire below. If you meet the main selection criteria, you will be contacted to discuss the clinical study and your interest in participating in it in more detail.

Completing this questionnaire does not commit you to participate in the study. You will still have time to discuss your participation with  your loved ones, your attending physician, and the study medical team as you wish.