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A phase III, randomized, controlled, single-blind, multicentre, parallel arm trial to assess the efficacy and safety of Pergoveris® (follitropin alfa and lutropin alfa) and GONAL-f® (follitropin alfa) for multifollicular development as part of an assisted reproductive technology treatment cycle in poor ovarian responders, as defined by the European Society of Human Reproduction and Embryology criteria

The primary objective of the trial is to demonstrate superiority of Pergoveris® versus GONAL-f® in poorovarian response (POR) patients defined according to modified criteria set forth by the European Society of Human Reproduction and Embryology (…

Psychosexual consequences of risk-reducing salpingo-oophorectomy in BRCA1/2 mutation carriers.

Primary objective The primary objective is to examine the effect of a MBSR intervention on the menopause-specific quality of life in BRCA1/2 mutation carriers who experience RRSO-induced menopausal complaints. Secondary objectiveThe secondary…

Prospective randomized trial to evaluate and to compare the impact of hysteroscopic Essure® intratubal device placement and laparoscopic salpingectomy on IVF-ET outcomes of patients with hydrosalpinx.

1. To evaluate and compare the impact of hysteroscopic Essure® intratubal device placement and laparoscopic salpingectomy on IVF-ET outcomes of patients with hydrosalpinx.2. It is still uncertain whether laparoscopic salpingectomy for hydrosalpinx…

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of MORAb-003 (farletuzumab) in Combination with Paclitaxel Therapy in Subjects with Platinum-Resistant or Refractory Relapsed Ovarian Cancer

To compare the effect of paclitaxel plus MORAb-003 to paclitaxel plus placebo on progression free survival (PFS) as determined by RECIST in subjects who are in a first platinum-resistant or refractory relapse of ovarian cancer.

Laparoscopy to predict the result of primary cytoreductive surgery in advanced ovarian cancer patients.

To investigate whether laparoscopy is cost-effective in predicting which patients will benefit from primary surgery and which patients should be treated with neoadjuvant chemotherapy and interval surgery instead.

Longterm lifestyle behaviour modification in overweighted women with polycystic ovary syndrome (PCOS).

Primary: Evaluation of the effectivity of a multidisciplinary cognitive behavioural lifestyle program combined with a Short Message Service (SMS) maintenance treatment with infertile overweight and obese PCOS women.

Phase III randomised clinical trial for stage III ovarian carcinoma randomising between secondary debulking surgery with or without hyperthermic intraperitoneal chemotherapy (OVHIPEC-I)

Objective: The primary objectives of this study are comparing the duration of recurrence free survival following completion of treatment between the 2 study arms. Secondary objectives of this study involves toxicity and morbidity, quality of life,…

A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients who have achieved a Complete Clinical Response after Standard Platinum/Taxane Containing Chemotherapy

The objective of this phase IIb is to compare the efficacy and safety of sorafenib to placebo of patients with ovarian epithelial or primary peritoneal cancers stage IIIb and IV who have achieved a complete clinical response after standard platinum/…

A Phase 3 Randomized, Double-blind, Placebo-controlled, Multicenter Study of AMG 386 With Paclitaxel and Carboplatin as First-line Treatment of Subjects With FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers

To estimate the treatment effect and safety of AMG 386 in combination with paclitaxel + carboplatin in subjects with FIGO Stage III-IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancers.

Is Hysterosalpingo-Foam Sonography (HyFoSy) a cost-effective alternative for hysterosalpingography (HSG) in assessing tubal patency in subfertile women?

The objective of this study is to assess the costs and effects of two strategiesof tubaI testing during the fertility work-up, one based on the new technique hysterosalpingo-foam sonography (HyFoSy) (innovative strategy) and the other on…

A Phase 3, Multicenter, Randomized, Open-Label Study of Avelumab (MSB0010718C) Alone or in Combination with Pegylated Liposomal Doxorubicin versus Pegylated Liposomal Doxorubicin Alone to In Patients with Platinum-Resistant/Refractory Ovarian Cancer

Primary Objective* To demonstrate that avelumab given alone or in combination with Pegylatedliposomal doxorubicin (PLD) is superior to PLD alone in prolonging Overall Survival(OS) in patients with platinum -resistant/platinum-refractory ovarian…

Tubal flushing with oil-based contrast during HSG in subfertile women: Is early flushing effective and cost-effective as compared to delayed flushing?

The aim of this study is to determine whether direct tubal flushing with oil-based contrast at HSG incorporated in the fertility work-up results in 10% more ongoing pregnancies and a shorter time to pregnancy, which will therefore be effective and…

Oil- based versus water-based contrast media for hysterosalpingography (HSG) in infertile women with unevaluated indications: a randomized controlled trial

This study has been transitioned to CTIS with ID 2024-512571-12-00 check the CTIS register for the current data. The objective of the proposed study is to assess the effectiveness and cost-effectiveness of the use of oil versus water-based contrast…

A RANDOMIZED, DOUBLE-BLIND, PHASE 3 COMPARISON OF PLATINUM-BASED THERAPY WITH TSR 042 AND NIRAPARIB VERSUS STANDARD OF CARE PLATINUM-BASED THERAPY AS FIRST LINE TREATMENT OF STAGE III OR IV NONMUCINOUS EPITHELIAL OVARIAN CANCER

This study has been transitioned to CTIS with ID 2024-510605-28-00 check the CTIS register for the current data. Primary Objective• To compare the progression free survival (PFS) of programmed death-ligand 1 (PD-L1) positive patients with Stage III…

MIRASOL: A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers with High Folate Receptor-Alpha Expression

Primary Objective:• To compare the progression-free survival (PFS) of patients randomized to mirvetuximab soravtansine (MIRV) vs. Investigator*s choice of chemotherapy (IC Chemo) Key Secondary Objectives:• To compare the objective response rate (ORR…

Pain in endometriosis and the relation to Lifestyle (PEARL). Effectiveness of a dietary intervention and cognitive behavioral therapy in endometriosis-associated pain

To investigate the effectiveness of an anti-inflammatory diet in reducing pain symptoms among patients with endometriosis and to explore whether the addition of CBT enhances this pain-reducing effect apart from the effect of CBT alone. The secondary…

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96 / ENGOT-ov65)

This study has been transitioned to CTIS with ID 2023-506177-35-00 check the CTIS register for the current data. Objective: To compare pembrolizumab plus paclitaxel with or without bevacizumab to placebo plus paclitaxel with or without bevacizumab,…

Is, in infertile women undergoing a basic fertility work-up, tubal flushing with oil-based contrast medium during hysterosalpingography (HSG) cost-effective compared to tubal flushing by hysterosalpingo-foam sonography (HyFoSy)? A randomized controlled trial.

The main objective of this study is to determine whether tubal flushing with oil-based contrast during HSG results into more pregnancies leading to live births when compared to tubal flushing with ExEm-foam during HyFoSy, and whether this approach…

PiSARRO: p53 Suppressor Activation in Recurrent High Grade Serous Ovarian Cancer, a Phase Ib/II Study of Systemic Carboplatin/Pegylated Liposomal Doxorubicin Combination Chemotherapy With or Without APR-246

Primary Objective: * To make a preliminary assessment of the efficacy of a combined APR-246 and carboplatin/PLD chemotherapy regimen in patients with platinum sensitive recurrent HGSOC with mutated p53.Secondary Objective: * To assess the safety…

A Randomized, Open-Label, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Avelumab (MSB0010718C) in Combination with and/or Following Chemotherapy in Patients with Previously Untreated Epithelial Ovarian Cancer

Co Primary Objectives:1. To demonstrate that avelumab in combination with platinum based chemotherapy followed by avelumab maintenance (Arm C) is superior to platinum based chemotherapy alone followed by observation (Arm A) in prolonging progression…