Clinical trials: Intrauterine Diseases
Leiomyoma, Uterine Fibroids
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
The primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bleeding.
- Conditions
- Leiomyoma, Uterine Fibroids, Menorrhagia
- Trial name
- FAST (NCT00768742)
- Testing
- VizAblate Intrauterine Ultrasound-Guided RF Ablation
- Where
- 3 sites in Canada
- Sponsor
- Gynesonics
Menorrhagia
Sonography Guided Transcervical Ablation of Uterine Fibroids
The objective of this study is to establish the safety and effectiveness of the Sonata® System in the treatment of symptomatic uterine fibroids.
- Trial name
- SONATA (NCT02228174)
- Testing
- Intrauterine Ultrasound-Guided Radiofreq. Ablation System
- Where
- 23 sites in United States, Mexico
- Volunteers
- 147 people
- Sponsor
- Gynesonics
Preterm Labor, Preterm Birth
MIRACLE of LIFE Study
The goal of this observational study is to develop and validate cell-free RNA-based biomarkers for predicting a variety of adverse pregnancy outcomes in a pregnant person population. The main question it aims to answer are: 1.
- Conditions
- Preterm Labor, Preterm Birth, Preterm Birth Complication, Preterm Premature Rupture of Membrane
- Trial name
- MoL (NCT06074601)
- Testing
- Mirvie Predictive Test for Adverse Pregnancy Outcomes
- Where
- 10 sites in United States
- Volunteers
- 10,000 people
- Sponsor
- Mirvie
Hydrops Fetalis, Fetal Growth Retardation
Amniotic Fluid Tandem Mass Spectrometry for Pregnancies Complicated by NIH and Severe Symmetrical IUGR
The objective of this pilot study is to prospectively evaluate amniotic fluid of pregnancies complicated by non-immune hydrops and severe symmetrical intrauterine growth restriction by tandem mass spectrometry for inborn errors…
- Trial name
- TandemMS (NCT00143039)
- Testing
- Tandem MS test for inborn errors of metabolism
- Where
- 11 sites in United States
- Volunteers
- 48 people
- Sponsor
- Obstetrix Medical Group
Uterine Hemorrhage
Management of Initial Bleeding/Spotting Associated With the Levonorgestrel-releasing Intrauterine System (MIRENA)
The purpose of the study is to investigate if the study drugs (tranexamic acid or mefenamic acid) can control irregular bleeding during the first 3 months of using Mirena.
- Trial name
- NCT01295294
- Testing
- Tranexamic acid, Mefenamic acid, Mirena (Levonorgestrel IUS, BAY86-5028)
- Where
- 12 sites in Denmark, Ireland and 1 more
- Volunteers
- 187 people, healthy volunteers welcome
- Sponsor
- Bayer
Intrauterine Devices
Study on Medical Records of Women Using an Intrauterine Device (IUD) to Analyze the Risks That the IUD Will be Expelled or Perforates the Womb in Relation to Breastfeeding, the Point in Time When the IUD Was Inserted After Childbirth and in Relation to Different Types of IUDs
Study to analyze electronic medical records of women using an intrauterine device (IUD). The study was required by the FDA for the marketed IUD Mirena (US Post-marketing requirement; short name of study: APEX IUD).
- Trial name
- APEX IUD (NCT03754556)
- Testing
- Intrauterine device
- Where
- 4 sites in United States
- Volunteers
- 326,658 people, healthy volunteers welcome
- Sponsor
- Bayer
Infertility
A Study to Evaluate the Baseline Follicle Stimulating Hormone, Ovarian Volume and Antral Follicle Count as Prognostic Factors of the Outcome of In-vitro Fertilisation/Intracytosolic Sperm Injection in Infertile Patients Receiving Gonal f for Controlled Ovarian Hyperstimulation
This is a phase IV non-interventional, multicentric observational study to evaluate the baseline follicle stimulating hormone (FSH) levels, ovarian volume, antral follicle count (AFC) and age as prognostic factors of the outcome…
- Trial name
- NCT01196143
- Where
- Greece
- Volunteers
- 356 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Pregnancy, Ectopic
Occurrence and Trend of Pregnancies Growing Outside the Womb (Ectopic Pregnancy) 2009-2018. A Study on a Defined Group of Persons
In this trial researchers want to learn more about the occurrence of pregnancies growing outside the womb over the last decade (2009-2018) and the potential risk factors associated with pregnancies growing outside the womb.
- Trial name
- NCT03670784
- Testing
- No intervention
- Where
- United States
- Volunteers
- 3,922,877 people
- Sponsor
- Bayer
Infertility, Intrauterine Insemination
Personalized Insemination Treatment Study
This study is intended for women undergoing their first cycle of 3 intrauterine inseminations. All 3 inseminations will be personalized by using algorithms to determine the dose of study medication.
- Conditions
- Infertility, Intrauterine Insemination, Reproduction
- Trial name
- PITS (NCT03830723)
- Testing
- Follitropin delta
- Where
- Canada
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Clinique Ovo
Infertility
Study Evaluating the Timing of Intrauterine Insemination in Relation to Positive Home Ovulation Prediction Kit
The aim of this study is to assess the impact of the timing of intrauterine insemination (IUI) in relation to the natural surge of luteinizing hormone (LH), as detected by home ovulation predictor kits, on pregnancy rates per…
- Trial name
- NCT02294773
- Testing
- Intrauterine Insemination, Clomiphene, Letrozole
- Where
- 2 sites in United States
- Volunteers
- 13 people
- Sponsor
- Midwest Fertility Specialists
Gynecologic Disease
To Evaluate Anti-adhesive Effect and Safety of a Mixed Solid of Poloxamer, Gelatin and Chitosan(Mediclore®)
The purpose of this study is to evaluate the efficacy and safety of Mediclore®, as an antiadhesive barrier, which is made of Poloxamer, Gelatin and Chitosan.
- Trial name
- antiadhesion (NCT02957500)
- Testing
- Mediclore® (adhesion barrier)
- Where
- South Korea
- Volunteers
- 198 people
- Sponsor
- CGBio Inc.
Intrauterine Adhesion
Assessment of Uterine Access, Uterine Patency and Intrauterine Adhesions Following Endometrial Ablation
The objective of this study is to gain information concerning the acute and longer-term morphological changes within the uterus following endometrial ablation.
- Trial name
- NCT04824430
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Rejoni Inc.
Asherman Syndrome, Intrauterine Adhesion
PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film.
PREG2 is a randomized controlled trial that aims to evaluate efficacy in preventing intrauterine adhesion recurrence after hysteroscopic adhesiolysis of a novel intrauterine barrier film named Womed Leaf
- Trial name
- PREG2 (NCT04963179)
- Testing
- Womed Leaf
- Where
- 15 sites in Belgium, China and 5 more
- Volunteers
- 160 people
- Sponsor
- Womed
Leiomyoma, Uterine Fibroids
Fibroid Ablation Study - Large Fibroids
The purpose of this study is to establish the effectiveness and confirm the safety of the VizAblate System in the ablation of large (> 5 cm) symptomatic uterine fibroids.
- Conditions
- Leiomyoma, Uterine Fibroids, Menorrhagia
- Trial name
- FAST-L (NCT01539187)
- Testing
- VizAblate System
- Where
- 10 sites in Mexico, Netherlands and 1 more
- Volunteers
- 6 people
- Sponsor
- Gynesonics
Intrauterine Adhesion
PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film
Intrauterine adhesions (IUA) are the major long-term complication of intrauterine procedures and are associated with pelvic pain, menstrual disorders, obstetrical complication and infertility.
- Trial name
- PREG1 (NCT04381728)
- Testing
- Womed Leaf
- Where
- 6 sites in Belgium, France and 1 more
- Volunteers
- 23 people
- Sponsor
- Womed
Intrauterine Adhesion
The Efficacy of A New Crosslinked Hyaluronan Gel in Prevention of Intrauterine Adhesion
Using American Fertility Society classification of intrauterine adhesions, the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation and curettage for delayed miscarriage in…
- Trial name
- NCT03353909
- Testing
- new crosslinked hyaluronan gel
- Volunteers
- 300 people
- Sponsor
- BioRegen Biomedical (Changzhou) Co., Ltd