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RCT comparing insertion of levonorgestrel releasing intrauterine system (Mirena) during the menstruation compared with random insertion beyond menstruations in patient-perceived pain.

In this randomized study, timing during (day 1-7 of the menstruation cycle WITH vaginal blood loss) or beyond menstruation (in menstruation cycle day 8 and further WITHOUT vaginal blood loss) will be compared regarding differences in patient-…

A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of NGM/EE Tablets Manufactured at 2 Different Facilities

- To establish the bioequivalence of the hormones norgestimate, norelgestromin, and ethinyl estradiol in NGM/EE Schaffhausen tablets compared with the same hormones in NGM/EE Manati tablets.- To assess the safety and tolerability of both…

Hysteroscopic resection of uterine scar defects (niche) in patients with abnormal bleeding, a randomised controlled trial

Our primary objective is to study the effectiveness of hysteroscopic resection for niche related uterine bleeding disorders. The procedure will be performed in small niches with a residual myometrium of more than 3mm.Our secondary objective is to…

A RANDOMISED CONTROLLED TRIAL COMPARING BALLOON ENDOMETRIAL ABLATION (THERMABLATE) VERSUS BIPOLAR ENDOMETRIAL ABLATION (NOVASURE) IN THE OUTPATIENT CLINIC WITH LOCAL ANESTHESIA

The purpose of the study is to evaluate the effectiveness and acceptability of the hot fluid balloon endometrial Thermablate ablation system compared with the Bipolar RF Novasure ablation treatment performed in an outpatient setting in eliminating…

Reducing Gas Embolisation During Hysteroscopic Surgery by limiting the amount of intravasation with the installation of intracervical terlipressin (HYSTER)

Objective: The primary objective of the study is to determine whether the intracervical installation of vasopressin reduces the incidence and severity of gas embolism as detected by trans oesophageal echocardiography (TOE…

RCT comparing the levonorgestrel releasing intrauterine system (Mirena) versus endometrial ablation in women suffering from menorrhagia

We plan to compare the costs and effects of both methods.

A randomized, parallel-group, double-blind placebo-controlled and open label active-controlled, multi-center study to assess the efficacy and safety of vilaprisan in patients with uterine fibroids

The primary objective of this study is• To assess the efficacy of vilaprisan in subjects with uterine fibroids compared to placebo.The secondary objectives of this study are• To assess the efficacy of vilaprisan in subjects with uterine fibroids…

Procedural sedation for hysteroscopic myomectomy: cost effectiveness

Is hysteroscopic resection of submucous myomas under procedural sedation with propofol (PSA) in an outpatient setting a cost-effective alternative for hysteroscopic myomectomy performed under general anesthesia in the operation room?

How 2 deal with PCOS

To study if an online brief CBT intervention is effective for anxiety and depression compared to care as usual (CAU) in patients with PCOS

The hand driven hysteroscopic tissue removal system (Resectr 9Fr) versus motor driven hysteroscopic tissue removal system (Truclear) for removal of polyps: A randomized controlled trail.

Primary Objective: Comparing installation and operating time between the Truclear HM device and the Resectr HM device for removal of intrauterine large polyps.Secondary Objective(s): Comparing data on peri- and post operative complications (e.g.…

A randomized, parallel-group, multicenter study to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids

The primary objective of this study is to assess the efficacy and safety of vilaprisan in subjects with uterine fibroids compared to ulipristal. The secondary objective of this study is to evaluate the efficacy and safety of different treatment…

A randomised controlled trial comparing endometrial ablation plus levonorgestrel releasing intrauterine system versus endometrial ablation alone in women with heavy menstrual bleeding (MIRA 2 trial).

To determine whether the introduction of a levonorgestrel-releasing intrauterine system (LNG-IUS) directly after endometrial ablation (EA) alleviates pain and heavy menstrual bleeding and reduces the need for subsequent hysterectomy compared with…

Symptomatic niches for laparoscopic niche resection, a randomized clinical trial

Set up an RCT to study whether a laparoscopic niche resection is superior over hormonal therapy as treatment of niche-related gynaecological complaints for women with a large symptomatic niche, and without a child wish.