Blockade of tubal patency following transcervical administration of polidocanol foam: Initial studies in rhesus macaques

Jeffrey Jensen, Carol Hanna, Shan Yao, Elizabeth Micks, Alison Edelman, Lindsay Holden, Ov Slayden

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Objective To demonstrate the feasibility of polidocanol foam (PF) as a nonsurgical method of female permanent contraception using a nonhuman primate model. Study Design Four groups of adult female rhesus macaques underwent either transcervical treatment with 5% PF directly into the uterine cavity, treatment with inert (methylcellulose, MF) foam or no treatment followed by removal of the reproductive tract for histologic evaluation. Untreated animals were included in Group 1 (n= 3). Group 2 animals (n= 4) were treated once with MF. Group 3 (n= 7) received a single, and Group 4 (n= 5) received multiple monthly treatments with PF; in these 2 groups, baseline tubal patency was assessed either laparoscopically by chromopertubation (CP) or by hysterosalpingography. Results Group 1 (untreated) and Group 2 (MF) animals had normal tubal histology. In contrast, Group 3 and 4 females treated with PF showed evidence of tubal damage. In Group 4, bilateral tubal blockade was noted on CP after two (n= 2) or three (n= 3) treatments. Histologic analysis confirmed complete tubal occlusion (loss of epithelium, fibrosis) in three of these animals, and one showed significant tubal damage localized to the intramural segment. Nontarget (cervix, vagina, endometrium, ovary) reproductive tissues were unaffected. While similar tubal changes were observed after a single treatment (Group 3), endometrial hemorrhage was also noted as an acute change. Conclusion PF is a promising candidate agent for nonsurgical permanent female contraception. The histologic features of PF occlusion are confined to the intramural portion of the tube. Implications This study in rhesus macaques supports further development of transcervical administration of PF as a nonsurgical approach to permanent contraception. A nonsurgical method could reduce risks and costs associated with surgical female sterilization and increase access to permanent contraception.

Original languageEnglish (US)
Pages (from-to)540-549
Number of pages10
JournalContraception
Volume89
Issue number6
DOIs
StatePublished - 2014

Fingerprint

Macaca mulatta
Contraception
Therapeutics
Reproductive Sterilization
Hysterosalpingography
Tubal Sterilization
Methylcellulose
Vagina
Endometrium
polidocanol
Cervix Uteri
Primates
Ovary
Histology
Fibrosis
Epithelium
Hemorrhage
Costs and Cost Analysis

Keywords

  • Female
  • Nonhuman primate
  • Nonsurgical
  • Sterilization
  • Tubal occlusion

ASJC Scopus subject areas

  • Reproductive Medicine
  • Obstetrics and Gynecology
  • Medicine(all)

Cite this

Blockade of tubal patency following transcervical administration of polidocanol foam : Initial studies in rhesus macaques. / Jensen, Jeffrey; Hanna, Carol; Yao, Shan; Micks, Elizabeth; Edelman, Alison; Holden, Lindsay; Slayden, Ov.

In: Contraception, Vol. 89, No. 6, 2014, p. 540-549.

Research output: Contribution to journalArticle

@article{7af3779c3c5442129cfc71a3792f28f1,
title = "Blockade of tubal patency following transcervical administration of polidocanol foam: Initial studies in rhesus macaques",
abstract = "Objective To demonstrate the feasibility of polidocanol foam (PF) as a nonsurgical method of female permanent contraception using a nonhuman primate model. Study Design Four groups of adult female rhesus macaques underwent either transcervical treatment with 5{\%} PF directly into the uterine cavity, treatment with inert (methylcellulose, MF) foam or no treatment followed by removal of the reproductive tract for histologic evaluation. Untreated animals were included in Group 1 (n= 3). Group 2 animals (n= 4) were treated once with MF. Group 3 (n= 7) received a single, and Group 4 (n= 5) received multiple monthly treatments with PF; in these 2 groups, baseline tubal patency was assessed either laparoscopically by chromopertubation (CP) or by hysterosalpingography. Results Group 1 (untreated) and Group 2 (MF) animals had normal tubal histology. In contrast, Group 3 and 4 females treated with PF showed evidence of tubal damage. In Group 4, bilateral tubal blockade was noted on CP after two (n= 2) or three (n= 3) treatments. Histologic analysis confirmed complete tubal occlusion (loss of epithelium, fibrosis) in three of these animals, and one showed significant tubal damage localized to the intramural segment. Nontarget (cervix, vagina, endometrium, ovary) reproductive tissues were unaffected. While similar tubal changes were observed after a single treatment (Group 3), endometrial hemorrhage was also noted as an acute change. Conclusion PF is a promising candidate agent for nonsurgical permanent female contraception. The histologic features of PF occlusion are confined to the intramural portion of the tube. Implications This study in rhesus macaques supports further development of transcervical administration of PF as a nonsurgical approach to permanent contraception. A nonsurgical method could reduce risks and costs associated with surgical female sterilization and increase access to permanent contraception.",
keywords = "Female, Nonhuman primate, Nonsurgical, Sterilization, Tubal occlusion",
author = "Jeffrey Jensen and Carol Hanna and Shan Yao and Elizabeth Micks and Alison Edelman and Lindsay Holden and Ov Slayden",
year = "2014",
doi = "10.1016/j.contraception.2013.11.017",
language = "English (US)",
volume = "89",
pages = "540--549",
journal = "Contraception",
issn = "0010-7824",
publisher = "Elsevier USA",
number = "6",

}

TY - JOUR

T1 - Blockade of tubal patency following transcervical administration of polidocanol foam

T2 - Initial studies in rhesus macaques

AU - Jensen, Jeffrey

AU - Hanna, Carol

AU - Yao, Shan

AU - Micks, Elizabeth

AU - Edelman, Alison

AU - Holden, Lindsay

AU - Slayden, Ov

PY - 2014

Y1 - 2014

N2 - Objective To demonstrate the feasibility of polidocanol foam (PF) as a nonsurgical method of female permanent contraception using a nonhuman primate model. Study Design Four groups of adult female rhesus macaques underwent either transcervical treatment with 5% PF directly into the uterine cavity, treatment with inert (methylcellulose, MF) foam or no treatment followed by removal of the reproductive tract for histologic evaluation. Untreated animals were included in Group 1 (n= 3). Group 2 animals (n= 4) were treated once with MF. Group 3 (n= 7) received a single, and Group 4 (n= 5) received multiple monthly treatments with PF; in these 2 groups, baseline tubal patency was assessed either laparoscopically by chromopertubation (CP) or by hysterosalpingography. Results Group 1 (untreated) and Group 2 (MF) animals had normal tubal histology. In contrast, Group 3 and 4 females treated with PF showed evidence of tubal damage. In Group 4, bilateral tubal blockade was noted on CP after two (n= 2) or three (n= 3) treatments. Histologic analysis confirmed complete tubal occlusion (loss of epithelium, fibrosis) in three of these animals, and one showed significant tubal damage localized to the intramural segment. Nontarget (cervix, vagina, endometrium, ovary) reproductive tissues were unaffected. While similar tubal changes were observed after a single treatment (Group 3), endometrial hemorrhage was also noted as an acute change. Conclusion PF is a promising candidate agent for nonsurgical permanent female contraception. The histologic features of PF occlusion are confined to the intramural portion of the tube. Implications This study in rhesus macaques supports further development of transcervical administration of PF as a nonsurgical approach to permanent contraception. A nonsurgical method could reduce risks and costs associated with surgical female sterilization and increase access to permanent contraception.

AB - Objective To demonstrate the feasibility of polidocanol foam (PF) as a nonsurgical method of female permanent contraception using a nonhuman primate model. Study Design Four groups of adult female rhesus macaques underwent either transcervical treatment with 5% PF directly into the uterine cavity, treatment with inert (methylcellulose, MF) foam or no treatment followed by removal of the reproductive tract for histologic evaluation. Untreated animals were included in Group 1 (n= 3). Group 2 animals (n= 4) were treated once with MF. Group 3 (n= 7) received a single, and Group 4 (n= 5) received multiple monthly treatments with PF; in these 2 groups, baseline tubal patency was assessed either laparoscopically by chromopertubation (CP) or by hysterosalpingography. Results Group 1 (untreated) and Group 2 (MF) animals had normal tubal histology. In contrast, Group 3 and 4 females treated with PF showed evidence of tubal damage. In Group 4, bilateral tubal blockade was noted on CP after two (n= 2) or three (n= 3) treatments. Histologic analysis confirmed complete tubal occlusion (loss of epithelium, fibrosis) in three of these animals, and one showed significant tubal damage localized to the intramural segment. Nontarget (cervix, vagina, endometrium, ovary) reproductive tissues were unaffected. While similar tubal changes were observed after a single treatment (Group 3), endometrial hemorrhage was also noted as an acute change. Conclusion PF is a promising candidate agent for nonsurgical permanent female contraception. The histologic features of PF occlusion are confined to the intramural portion of the tube. Implications This study in rhesus macaques supports further development of transcervical administration of PF as a nonsurgical approach to permanent contraception. A nonsurgical method could reduce risks and costs associated with surgical female sterilization and increase access to permanent contraception.

KW - Female

KW - Nonhuman primate

KW - Nonsurgical

KW - Sterilization

KW - Tubal occlusion

UR - http://www.scopus.com/inward/record.url?scp=84901597233&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84901597233&partnerID=8YFLogxK

U2 - 10.1016/j.contraception.2013.11.017

DO - 10.1016/j.contraception.2013.11.017

M3 - Article

C2 - 24560476

AN - SCOPUS:84901597233

VL - 89

SP - 540

EP - 549

JO - Contraception

JF - Contraception

SN - 0010-7824

IS - 6

ER -