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Clinical trials

During our last General Assembly, it was decided to provide patients in Belgium with information on ongoing clinical studies. This decision was made for 2 reasons:

- For some patients, none of the current treatments work, and they might find hope in taking part in studies; 

- We need research in order to advance with the treatment of endometriosis. 

 

This page presents only public and official information about currently running clinical studies for endometriosis in Belgium. The information is provided from the official source: http://www.clinicalstudies.gov/. The page does not have a promotional purpose but it is intended for information purposes only. 

 

Choosing to participate in a study is an important personal decision. Each patient should consult their doctor and family members or friends about deciding to join a study. 

 

For general information, see Learn About Clinical Studies.

Bayer Vaginal Ring Study - 12 weeks treatment, various locations in Belgium

A study to assess the efficacy and safety of different dose combinations of hormones in an intravaginal ring versus placebo and other hormones in women with symptomatic Endometriosis. 

 

Which patients qualify?

  • Premenopausal women 18 years and above at the time of screening.

  • Women with endometriosis confirmed by laparoscopy or laparotomy within the last ten years but not less than 8 weeks before the screening visit; 

  • Moderate to severe endometriosis-associated pelvic pain (EAPP) in the last 28 days before screening; 

  • Willingness to use only ibuprofen as rescue pain medication for EAPP, if needed according to investigator's instruction.

  • Patients who agree to the use of a non-hormonal barrier method (i.e. spermicide-coated condoms) for contraception from screening visit until the end of the study. This is not required if adequate contraception is achieved by vasectomy of the partner.

 

Check the link to the study here.

 

Preoperative Staging of Endometriosis With MRI (IDEAL) – Universitaire Ziekenhuizen Leuven

The purpose of the study is to evaluate the value of MRI in preoperative stratification of endometriosis patients needing surgical approach by gynaecologists only or multidisciplinary approach by gynaecologists, urologists or/and abdominal surgeons. 

All endometriosis lesions found on MRI will be checked during laparoscopy in order to determine how the MRI findings might have changed the decision to do a surgical approach by gynaecologists only or multidisciplinary approach by gynaecologists, urologists or/and abdominal surgeons. 

 

Who can take part?

Women with strong suspicion of deep infiltrating endometriosis, with already planned surgery.

 

Check the link to the study here.

 

Immediate IUI Versus Expectant Management in Postoperative Endometriosis Patients - 

Universitaire Ziekenhuizen Leuven

This study questions whether postoperative IUI is better than expectant management in infertile endometriosis patients with good prognosis based on their EFI (Endometriosis Fertility Index) score. 

 

Who can participate?:

  • Recent (<6months) complete laparoscopic endometriosis resection

  • Endometriosis fertility index (EFI) at least 7/10

  • Regular menstrual cycles (min 24days - max 38days) with proven ovulation

  • At least one functional tube at surgery, normal uterus 

  • Sperm sample of partner: normal or mild male factor

 

Efficacy of Trace Elements (food supplements) in the Treatment of Endometriosis: a Pilot Study

The primary objective of this pilot study is to evaluate the efficacy of trace elements, versus placebo, on the reduction of pain in endometriosis of an American Fertility Society (AFSr) score of 2 to 4, combined or not to an adenomyosis, during a chronic treatment of 4 months.

 

Who can participate?

  • Woman suffering from an AFSr 2 to 4 endometriosis (combined or not to an adenomyosis), confirmed by laparoscopy, laparotomy or MRI as well as by a biopsy (done within 3 years before inclusion in the study), treated or not with sexual hormones, contraceptive or not (stable treatment for minimum 2 months) or any other treatment

  • Time period of at least 6 months after surgical treatment

  • Age between 18 and 45 years

  • Non-menopausal woman

  • Baseline pain (Day -45 to -30) of at least 40 mm on a visual analog scale

  • No reduction of more than 20% of pain on the visual analog scale after the run-in placebo period.

 

Check the link to the study here.

 

Gonadotropin-releasing Hormone (GnRH) Downregulation Versus Oral Anticonception Prior to ART

in Postoperative Endometriosis Patients - Universitaire Ziekenhuizen Leuven

This is a clinical study measuring pregnancy rates per initiated assisted reproduction cycle. [Time Frame: participants will be followed for the duration of the ART cycle including the pregnancy test, an expected average of 10 weeks in the active comparator group and an expected average of 18 weeks in the experimental group ] 

 

Who can participate?

  • Patients with histologically proven endometriosis with complete treatment of all endometriosis lesions during laparoscopy

  • Patients with only first three ART cycles

  • Normal uterine cavity

  • Eligible for ovarian stimulation with long agonist protocol

 

Check the link to the study here.

 

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