Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Respiratory Aspiration

Leiomyoma

Myofibroma

Polyps

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anesthetics

Propofol

Remifentanil

Prilocaine

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, General

Analgesics, Opioid

Narcotics

Anesthetics, Local

General anesthesia: remifentanil and propofol Deep sedation: remifentanil, propofol and citanest

Remifentanil, propofol and citanest

Igor Filipovski

The primary endpoint is to investigate the difference in pain between patients who receive deep sedation with spontaneous breathing versus patients who receive general anesthesia.

Investigate the difference between two types of anesthesia.

Comparing Two Types of Sedation to Gynaecological Patients

Deep Sedation in Spontaneously Breathing Patients Combined With Local Anesthesia Versus General Anesthesia in Gynecological Patients at Same Day Surgical at Hospitalsenheden Horsens

Measuring postoperative pain in TCRE, TCRF or TCRP patients

Operating time Recovery time Discharge time

The type and quantity of painkillers and nausea medication. Remifentanil, propofol, citanest, efedrin og atropin.

Previous anestetics, pain, PONV, fever, bleeding, discharge time.

Regionshospitalet Horsens

University of Aarhus

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Infertility

Neoplasms, Connective Tissue

Connective Tissue Diseases

Women with submucosal leimyomas undergoing hysteroscopical removal of the leiomyoma

Women with intramural leiomyomas undergoing myomectomy

Patients treated at the Department for Reproductive Medicine at the Oslo University hospital failing to conceive after 3 or more embryo transfers with good quality embryos.

Healthy, volunteering women with proved fertility with 1 or more deliveries and no history of infertility

Transcervical resection of fibroids

Myomectomy per laparoscopy or laparotomy

Thea F. Mikkelsen, MD

Kirsten Hald, PhD

Thea F Mikkelsen, MD

We aim to explore some of the molecular factors that reduce fertility for women with leiomyomas, taking into account leiomyoma location, size, number and vascularity. Tissue samples from the endometrium and leiomyomas will be obtained during the mid secretory phase before and 3-6 months after surgical excision for a comprehensive search for key molecular derangements.

Baseline medical information and standard questionnaire to record symptoms are collected from all participants and a gynaecological examination and a 2D and 3D vaginal ultrasonography including saline infusion sonography (SIS), if indicated, are performed. Blood samples for the biobank for extraction of germ line DNA and for identification of possible biomarkers are taken.

The women with submucosal leiomyomas will undergo hysteroscopic myomectomy and the women with intramural leiomyomas will undergo myomectomy per laparoscopy or laparotomy.

For the participants with intramural leiomyomas and the fertile/infertile controls, endometrial samples are taken with an endometrial suction curette in an outpatient setting at day 19-23 of the menstrual cycle. The endometrial sampling in the group of women with submucosal leiomyomas is being done during the hysteroscopic removal of the leiomyoma, also at day 19-23 of the menstrual cycle.

3-6 months after surgery, cycle day 19-23, endometrial samples will be taken from the women who have undergone myomectomy and ultrasound examination is being performed. The women with submucosal leiomyomas will undergo a second look hysteroscopy

Endometrial biopsies Leiomyoma biopsy Serum Plasma Blood cells

The biological sex must be female since we are studying a phenomenone occuring in the female genital tract.

Fibroids and Infertility - a Study of the Significance of Removal of Fibroids With Regard to Endometrial Receptivity

Mechanisms of Reduced Fertility in Women With Uterine Leiomyomas

Fold change of HOXA 10 Expression 3-6 months after myomectomy compared to pre-surgery Levels

Fold change of other molecular markers than HOXA 10 of endometrial receptivity 3-6 months after myomectomy and compared to fertile/infertile controls

VI and FI of the endometrium and subendometrial myometrium of women with leimyomas 3-6 months after myomectomy and compared to fertile/infertile controls

Vascular characteristics of leiomyomas associated with endometrial changes

Leiomyomas size in centimeters associated with endometrial changes

Leiomyoma location associated with endometrial changes

Genomic characteristics of leiomyomas associated with endometrial changes

Scar/fibrosis/adhesion formation after myomectomy; macroscopically and histologically

Pregnancy and deliveries within 2 years after myomectomy.

Difference in HOXA 10 expression in endometrium of women with leiomyomas compared to fertile/infertile controls

Difference in expression of molecular markers in endometrium adjacent to the leiomyoma compared to endometrium remote from the leiomyoma.

Alterations in molecular markers of endometrial receptivity after partially resected submucosal leiomyomas.

Difference in expression of molecular markers in endometrium of women with submucosal leiomyomas compared with endometrium in women with intramural leiomyomas.

Biomarkers in blood related to leiomyomas and a possible correlation between certain biomarkers and reduced endometrial receptivity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparing Two Types of Sedation to Gynaecological Patients	NCT01412632	Transcervical R... Transcervical R... Transcervical R...	Remifentanil, p...	18 Years -	University of Aarhus
Fibroids and Infertility - a Study of the Significance of Removal of Fibroids With Regard to Endometrial Receptivity	NCT04426760	Leiomyoma, Uter...	Transcervical r... Myomectomy per ...	18 Years - 40 Years	Oslo University Hospital

Spots Global Cancer Trial Database for transcervical resection of fibroids