SYMPRES Study

Women with a large niche and subfertility

Research into the effectiveness of laparoscopic niche resection, in comparison with conservative policy, on pregnancy outcomes in patients with a large niche and unexplained subfertility or an unsuccessful IVF treatment.

Purpose of the study

We want to find out whether the chance of pregnancy increases after a laparoscopic niche resection in comparison with non-resection. We will study this in women with a large niche, and who have not yet succeeded in becoming pregnant again.

In addition, we want to study the effect of the treatment on the chance of pregnancy, possible IUI, IVF or ICSI treatments, gynaecological complaints and costs.

We will study this by comparing two groups with one another. Patients who are eligible for inclusion in this study will be randomly assigned to the following groups:

1. The expectant group. This group will not undergo any surgery during 9 months. De patient is allowed, where applicable, to continue fertility treatment such as IUI, IVF or ICSI.
2. The intervention group. This group will undergo a laparoscopic niche resection and may not become pregnant during the next six months. A total of 200 women will participate in the study, 100 in each group.

What does participation entail?

Before participation: The defect (niche) in the uterus scar will be assessed in both groups using an internal water or gel contrast ultrasound scan. Measuring this is part of standard gynaecological procedures and takes place before randomisation because these data are needed in order to assess whether you can be considered eligible for this study. If you are undergoing surgery, we will repeat this ultrasound scan 3 months after the surgery.

During participation: If you are randomly selected for the expecant group, you will not receive surgery during the first  9 months after randomisation. You are allowed to get pregnant.

If so desired, after 9 months you can undergo surgery. If you do become pregnant, in general, caesarean section is advised after a pregnancy lasting 39 weeks.

If you are randomly selected for the intervention group, a laparoscopic niche resection will be performed, whereby the recess in your uterus will be removed. In order to ensure that the scar heals properly, you may not become pregnant during the first 6 months. This means that during these 6 months you may not start or continue fertility treatment such as IUI, IVF or ICSI. This is permitted after 6 months. If you become pregnant after surgery, in general, caesarean section is advised after a pregnancy lasting 39 weeks.

If you get pregnant again, we would like to follow the pregnancy of all patients who participated in this study. This will involve making three external ultrasound scans during your routine checks at the outpatients department, to measure the thickness of the uterus wall at the location of the scar, at approximately 12, 20 and 30 weeks of your pregnancy. This means only the ultrasound scan when you are 30 weeks pregnant will be extra; the other two ultrasound scans can be made during routine ultrasound scans. We would also like to ask you a few questions after the pregnancy about the course of the pregnancy and your delivery.                           

Both groups will receive questionnaires at the start of the study, after 6 months, after 1 year and after 2 years. The questionnaires contain questions about your general heath, menstrual pain, a menstruation calendar, your experience in relation to sex, any fertility treatments and the outcomes of pregnancy. In addition, we ask you to keep a diary of your medication consumption, visits to doctors and hospitals and your sick leave.

What is expected of you

In order to ensure that this study takes place efficiently and for your own safety, it is important that you comply with the following agreements.

 The agreements are that you:

• do not participate in another medical scientific study.
• keep your appointments for visits.
• bring the study participation card with you. This states that you are participating in this study. It also states who should be contacted in an emergency. You should also show your card when you visit another doctor.

It is important that you contact the researcher:

• before you start to take other medicines. Even if these are homeopathic medicines, natural medicines, vitamins and/or OTC medicines.
• if you are admitted to hospital or treated in hospital.
• if you suddenly develop health problems.
• if you no longer want to participate in the study.
• if your contact details change.

The spotting calender app

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