The effect of levonorgestrel intrauterine device placement on serum CA-125 levels in healthy premenopausal women

Abstract Background This biomechanical analysis of hysterectomy specimens assesses the forces associated with intrauterine device placement. These include compressive forces required to cause uterine perforation with two commonly available commercial intrauterine device placement instruments and a metal uterine sound. Methods We obtained hysterectomy specimens at a single academic center. All specimens resulted from excision for benign conditions in premenopausal women by any operative method. Within one hour of excision, we stabilized uterine specimens in an apparatus specifically designed for this analysis. A single, experienced clinician performed all experimental maneuvers and measured forces with a Wagner FDIX-25 force gauge. The investigator applied traction on a tenaculum to approximate force used during an intrauterine device placement. The maximum compressive force to the uterine fundus was determined by using manufacturers’ placement instruments for two commercially available products and a metal sound. Results Sixteen individuals provided hysterectomy specimens. No complete perforations occurred while using loaded intrauterine devices; in a single observation the LNG IUS entered the myometrium. The plastic intrauterine device placement rod bowed in all attempts and did not perforate the uterine serosa at the fundus. A metal uterine sound created a complete perforation in all specimens (p < .001). The lowest mean maximum force generated occurred with the levonorgestrel intrauterine system placement instrument 12.3 N (SD ± 3.8 N), followed by the copper T380A intrauterine device placement instrument 14.1 N (SD ± 4.0 N), and highest for the metal sound 17.9 N (SD ± 7.6 N) (p < 0.01). Conclusions In this ex-vivo model, metal uterine sounds caused complete perforation and intrauterine device placement instruments did not. This study received Institutional Review Board (IRB0059096) approval.

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Ex-Vivo Forces Associated with Intrauterine Device Placement and Perforation: A Biomechanical Evaluation of Hysterectomy Specimens

10.21203/rs.3.rs-107763/v1 ◽

2020 ◽

Author(s):

Jane Duncan ◽

Kathryn E. Fay ◽

Jessica Sanders ◽

Benjamin Cappiello ◽

Jane Saviers-Steiger ◽

...

Keyword(s):

Ex Vivo ◽

Intrauterine Device ◽

Compressive Force ◽

Premenopausal Women ◽

Biomechanical Analysis ◽

Uterine Perforation ◽

Single Observation ◽

Institutional Review ◽

Academic Center ◽

Device Placement

Abstract Background: This biomechanical analysis of hysterectomy specimens assesses the forces associated with intrauterine device placement. These include compressive forces required to cause uterine perforation with two commonly available commercial intrauterine device placement instruments and a metal uterine sound.Methods: We obtained hysterectomy specimens at a single academic center. All specimens resulted from excision for benign conditions in premenopausal women by any operative method. Within one hour of excision, we stabilized uterine specimens in an apparatus specifically designed for this analysis. A single, experienced clinician performed all experimental maneuvers and measured forces with a Wagner FDIX-25 force gauge. The investigator applied traction on a tenaculum to approximate force used during an intrauterine device placement. The maximum compressive force to the uterine fundus was determined by using manufacturers’ placement instruments for two commercially available products and a metal sound. Results: Sixteen individuals provided hysterectomy specimens. No complete perforations occurred while using loaded intrauterine devices; in a single observation the LNG IUS entered the myometrium. The plastic intrauterine device placement rod bowed in all attempts and did not perforate the uterine serosa at the fundus. A metal uterine sound created a complete perforation in all specimens, (p<.001). The lowest mean maximum force generated occurred with the levonorgestrel intrauterine system placement instrument 12.3 N (SD±3.8N), followed by the copper T380A intrauterine device placement instrument 14.1 N (SD±4.0N), and highest for the metal sound 17.9N (SD±7.6N) (P<0.01).Conclusions: In this ex-vivo model, metal uterine sounds caused complete perforation and intrauterine device placement instruments did not. This study received Institutional Review Board approval (IRB0059096).

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Benign Ovarian Cysts with Raised CA-125 Levels: Do We Need to Evaluate the Fallopian Tubes?

Journal of Laboratory Physicians ◽

10.1055/s-0040-1722547 ◽

2020 ◽

Vol 12 (04) ◽

pp. 276-280

Author(s):

Devesh Sharma ◽

Anjali Vinocha

Keyword(s):

Ovarian Cancer ◽

Ovarian Cyst ◽

Transvaginal Ultrasound ◽

Premenopausal Women ◽

Carbohydrate Antigen ◽

Ca 125 ◽

Ovarian Cysts ◽

Fallopian Tubes ◽

Case Record ◽

Carbohydrate Antigen 125

Abstract Objectives It is not clearly known whether some benign (simple) ovarian cysts can convert into cancerous cysts. Size of cyst and wall abnormalities do predict the potentiality of malignancy. Not many studies have been done to explore the malignant potential of large-sized (> 5 cm) unilocular ovarian cysts without wall abnormalities. This study evaluated the correlation between ultrasonographic size of benign ovarian cysts and carbohydrate antigen 125 (CA-125) levels. Methodology Sixty (60) premenopausal women were recruited for the study preoperatively, based on transvaginal ultrasound (TVUS) findings present in the case record sheet received along with the CA-125 sample in the biochemistry laboratories. Those cases with elevated CA-125 levels were selected, where patients had unilocular ovarian cysts without wall abnormalities. CA-125 was done using ECLIA methodology (Cobas e411, Germany). Statistical correlation was calculated between the ovarian cyst size and CA-125 levels using Spearman’s Rho coefficient. Results Mean age group of subjects were 29.7 ± 7.3 years and mean value of CA-125 (normal < 35 IU/mL) was found to be increased: 118.0 ± 147.1 IU/mL so was the mean diameter of cysts (cut off ≤ 5 cm): 48.6 ± 59.8 cm. No correlation was found between CA-125 levels and volume of ovarian cyst (r = 0.005, p = 0.680) for all subjects. Conclusions The lack of correlation between size of ovarian cysts and CA-125 levels provides a hint that the ovarian cyst epithelium does not directly express CA-125 and it may come from sites like the fallopian tube. Thus, raised level of CA-125 in benign ovarian cyst should be followed-up more closely, demanding assessment of fallopian tubes for early diagnosis of ovarian cancer. Also, algorithms can be explored to include size of ovarian cyst and CA 125 levels to predict ovarian cancer.

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Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

10.21203/rs.3.rs-51837/v4 ◽

2020 ◽

Author(s):

Pedro Acién ◽

Irene Velasco ◽

Maribel Acién

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Transvaginal Ultrasound ◽

Intrauterine Device ◽

Conservative Surgery ◽

University Hospital ◽

Ca 125 ◽

Fertility Sparing ◽

Ultrasound Guided Puncture ◽

Guided Puncture

Abstract Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences. Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019). Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.

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Anastrozole and Levonorgrestrel-Releasing Intrauterine Device in the Treatment of Endometriosis: A Randomized Clinical Trial.

10.21203/rs.3.rs-51837/v2 ◽

2020 ◽

Author(s):

Pedro Acién ◽

Irene Velasco ◽

Maribel Acién

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Transvaginal Ultrasound ◽

Intrauterine Device ◽

Conservative Surgery ◽

University Hospital ◽

Ca 125 ◽

European Medicines Agency ◽

Fertility Sparing ◽

Ultrasound Guided Puncture

Abstract Background: To study the effectiveness of an aromatase inhibitor (Anastrozole) associated to levonorgestrel-releasing intrauterine device (LNG-IUD, Mirena®) in the treatment of endometriosis.Methods: Prospective, randomized clinical trial. Setting: University Hospital (single center). Elegibility criteria: Endometriomas >3×4 cm, CA-125>35 U/mL and endometriosis symptoms. Patients: Thirty-one women randomized to anastrozole+Mirena®+Conservative Surgery(CS) (n=8), anastrozole+Mirena®+transvaginal ultrasound-guided puncture-aspiration (TUGPA) (n=7), Mirena®+CS (n=9), or Mirena®+TUGPA (n=7). Interventions: Anastrozole 1 mg/day and/or only Mirena® for 6 months; CS (ovarian and fertility-sparing) or TUGPA of endometriomas one month after starting medical treatment. Main Outcome Measures: Visual analogic scale for symptoms, CA-125 levels, ultrasound findings of endometriomas and recurrences.Results: A significant improvement in symptoms during the treatment (difference of 43%, 95% CI 29.9-56.2) occurred, which was maintained at 1 and 2 years. It was more significant in patients treated with anastrozole (51%, 95% CI 33.3-68.7). For CA-125, the most significant decrease was observed without anastrozole (73.8%, 95% CI 64.2-83.4 vs. 53.8%, 95% CI 25.7-81.6 under Mirena®+anastrozole). After CS for endometriosis, a reduction of findings of endometriomas and long-term recurrences occurred, with or without anastrozole. At 4,2±1,7 years (95% CI 3,57-4,85), 88% of the patients who underwent CS were asymptomatic, without medication or reoperation, compared to only 21% if TUGPA was performed, with or without anastrozole (p=0.019).Conclusions: Dosing anastrozole for 6 months, starting one month before CS of endometriosis, reduces more significantly the painful symptoms and delays recurrences, but has no other significant advantages over the single insertion of LNG-IUD (Mirena®) during the same time. Anastrozole and/or only Mirena® associated with TUGPA are not effective.Details of trial registration: Eudra CT System of the European Medicines Agency (London, 29-Sept-2008) Nº EudraCT: 2008-005744-17 (07/11/2008). Date of enrolment of first patient: 15/01/2009.

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Impact of Minimally Invasive Gynecologic Surgery Fellowship Training on Concomitant Levonorgestrel-Releasing Intrauterine Device Placement at the Time of Laparoscopic Surgery

Journal of Minimally Invasive Gynecology ◽

10.1016/j.jmig.2015.08.750 ◽

2015 ◽

Vol 22 (6) ◽

pp. S210

Author(s):

C Vu ◽

E Hernly ◽

E Carey ◽

K Swan

Keyword(s):

Laparoscopic Surgery ◽

Minimally Invasive ◽

Intrauterine Device ◽

Fellowship Training ◽

Gynecologic Surgery ◽

Device Placement

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Same-Day Intrauterine Device Placement is Rarely Complicated by Pelvic Infection

Women s Health Issues ◽

10.1016/j.whi.2014.09.006 ◽

2015 ◽

Vol 25 (1) ◽

pp. 22-27 ◽

Cited By ~ 8

Author(s):

Melissa Papic ◽

Nan Wang ◽

Sara M. Parisi ◽

Erin Baldauf ◽

Glenn Updike ◽

...

Keyword(s):

Intrauterine Device ◽

Pelvic Infection ◽

Device Placement

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Vaginal microbiome changes with levonorgestrel intrauterine device placement

Contraception ◽

10.1016/j.contraception.2013.05.098 ◽

2013 ◽

Vol 88 (3) ◽

pp. 455-456

Author(s):

J. Jacobson ◽

A. Dermish ◽

I. Nygaard ◽

D. Turok

Keyword(s):

Intrauterine Device ◽

Vaginal Microbiome ◽

Device Placement

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Levonorgestrel Intrauterine Device Placement

Obstetrics and Gynecology ◽

10.1097/01.aog.0000463116.55677.44 ◽

2015 ◽

Vol 125 ◽

pp. 69S

Author(s):

Sabrina N. Wyatt ◽

Yan Li ◽

Jeffrey M. Szychowski ◽

Todd R. Jenkins

Keyword(s):

Intrauterine Device ◽

Device Placement

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Ileal Perforation after Intrauterine Device Insertion

Gynecology and Obstetrics Open Access Open Journal ◽

10.33169/gyne.obste.gaooaoj-2-109 ◽

2021 ◽

Vol 2 (1) ◽

pp. 35-37

Author(s):

Suleiman Ghunaim

Keyword(s):

Intrauterine Device ◽

Bowel Injury ◽

Intrauterine Contraceptive Device ◽

Transvaginal Sonography ◽

Uterine Perforation ◽

Contraceptive Device ◽

Intrauterine Contraceptive ◽

Clinical Surveillance ◽

Device Placement ◽

Device Use

The intrauterine contraceptive device is the second most popular form of contraception worldwide. Uterine perforations may rarely complicate intrauterine contraceptive device use and are believed to occur mostly at the time of insertion. In the majority of cases, perforations are not recognized by the operator and remain asymptomatic. In rare instances however, severe delayed complications involving adjacent organs may ensue. We report an unusual case of uterine perforation with bowel injury diagnosed two years after the insertion of a copper intrauterine contraceptive device. We aim to address the use of transvaginal sonography to confirm proper intrauterine contraceptive device placement following a technically challenging insertion, clinical surveillance, and prompt removal of an intraperitoneal intrauterine contraceptive deviceto prevent potential serious complications, such as bowel embedment. Keywords: Bleeding; Bowel injury; Contraception; Intrauterine contraceptive device; Uterine perforations. Abbreviations IUD: intrauterine contraceptive device; G2P2: Gravidity 2 Parity 2

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