Characterization of tubal occlusion after transcervical polidocanol foam (PF) infusion in baboons

Jeffrey T. Jensen; Carol Hanna; Shan Yao; Cassondra Bauer; Terry K. Morgan; Ov D. Slayden

doi:10.1016/j.contraception.2015.06.002

Characterization of tubal occlusion after transcervical polidocanol foam (PF) infusion in baboons

Jeffrey T. Jensen
, Carol Hanna
, Shan Yao
, Cassondra Bauer
, Terry K. Morgan
, Ov D. Slayden

Research output: Contribution to journal › Article › peer-review

13 Scopus citations

Abstract

Objective Our long-term goal is to develop a nonsurgical method of fallopian tubal occlusion for the purpose of permanent contraception. We have previously demonstrated that transcervical administration of 5% polidocanol foam (PF) can create tubal occlusion in macaques but that multiple treatments are required. In this study, we assessed the efficacy of various regimens of PF with and without depomedroxyprogesterone acetate (DMPA) (to control ovarian cycle phase) in the baboon. Study design Adult cycling female baboons were evaluated for tubal patency by hysterosalpingography and then received a transcervical infusion of PF with (+) or without (-) an intramuscular injection of DMPA (3.5 mg/kg). Two concentrations of PF were compared: 1% [(+) DMPA, n= 5; (-) DMPA, n= 3] and 5% [(+) DMPA, n= 4; (-) DMPA, n= 3]. Controls received (+) DMPA (n= 2) or (-) DMPA, (n= 3) only. The reproductive tracts were removed 1-3 months after treatment for examination. Results No fallopian tubal occlusion was observed in negative controls (± DMPA). Histologic complete tubal occlusion was observed in 3/8 of females treated with 1% PF and in 6/7 treated with 5% PF. Histologic evaluation suggested that 1% PF is associated with prolonged chronic inflammation (more than 2-3 months), while 5% treatment eliminates the epithelial lining, at least focally, and resolves into complete occlusion within 1-2 months. This pattern of complete occlusion was seen in all 4 females that received 5% PF (+ DMPA) and in 2/3 that received 5% PF (- DMPA). Conclusion In a baboon model of transcervical permanent contraception, a single treatment with 5% PF resulted in complete tubal occlusion more reliably (85%) than 1% PF (38%). Cotreatment with DMPA may improve treatment results with 5% PF but requires additional study. Implications A finding that a single transcervical treatment with 5% PF can occlude the fallopian tubes of baboon supports further study of this approach as a novel strategy for permanent contraception for women.

Original language	English (US)
Pages (from-to)	96-102
Number of pages	7
Journal	Contraception
Volume	92
Issue number	2
DOIs	https://doi.org/10.1016/j.contraception.2015.06.002
State	Published - Aug 1 2015

Funding

This research was supported by generous grants from the Bill & Melinda Gates Foundation ( OPP 1025233 and OPP1060424 ). This investigation used resources that were supported by the SNPRC grant P51 OD011133 and the Oregon National Primate Research Center grant P51OD011092 from the Office of Research Infrastructure Programs, NIH . The authors wish to thank the clinical veterinary staff and animal care technicians at SNPRC for their excellent animal care. Cook Medical Devices in Bloomington, IN, provided the catheters used in this study. Dr. Bauer is now associated with Lovelace Respiratory Research Institute, Albuquerque, NM.

Funders	Funder number
Office of Research Infrastructure Programs
SNPRC	P51 OD011133
Author National Institutes of Health National Institutes of Health National Institutes of Health National Institutes of Health The Bev Hartig Huntington's Disease Foundation National Institutes of Health	U54HD055744
The National Institute of Child Health and Human Development	K12HD085809
Bill and Melinda Gates Foundation	OPP1060424, OPP 1025233
Oregon National Primate Research Center	P51OD011092

Keywords

Baboon
Female
Nonsurgical sterilization
Permanent contraception
Polidocanol

ASJC Scopus subject areas

Reproductive Medicine
Obstetrics and Gynecology

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10.1016/j.contraception.2015.06.002

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@article{242319c9b48944be8260f702d693b210,

title = "Characterization of tubal occlusion after transcervical polidocanol foam (PF) infusion in baboons",

abstract = "Objective Our long-term goal is to develop a nonsurgical method of fallopian tubal occlusion for the purpose of permanent contraception. We have previously demonstrated that transcervical administration of 5\% polidocanol foam (PF) can create tubal occlusion in macaques but that multiple treatments are required. In this study, we assessed the efficacy of various regimens of PF with and without depomedroxyprogesterone acetate (DMPA) (to control ovarian cycle phase) in the baboon. Study design Adult cycling female baboons were evaluated for tubal patency by hysterosalpingography and then received a transcervical infusion of PF with (+) or without (-) an intramuscular injection of DMPA (3.5 mg/kg). Two concentrations of PF were compared: 1\% [(+) DMPA, n= 5; (-) DMPA, n= 3] and 5\% [(+) DMPA, n= 4; (-) DMPA, n= 3]. Controls received (+) DMPA (n= 2) or (-) DMPA, (n= 3) only. The reproductive tracts were removed 1-3 months after treatment for examination. Results No fallopian tubal occlusion was observed in negative controls (± DMPA). Histologic complete tubal occlusion was observed in 3/8 of females treated with 1\% PF and in 6/7 treated with 5\% PF. Histologic evaluation suggested that 1\% PF is associated with prolonged chronic inflammation (more than 2-3 months), while 5\% treatment eliminates the epithelial lining, at least focally, and resolves into complete occlusion within 1-2 months. This pattern of complete occlusion was seen in all 4 females that received 5\% PF (+ DMPA) and in 2/3 that received 5\% PF (- DMPA). Conclusion In a baboon model of transcervical permanent contraception, a single treatment with 5\% PF resulted in complete tubal occlusion more reliably (85\%) than 1\% PF (38\%). Cotreatment with DMPA may improve treatment results with 5\% PF but requires additional study. Implications A finding that a single transcervical treatment with 5\% PF can occlude the fallopian tubes of baboon supports further study of this approach as a novel strategy for permanent contraception for women.",

keywords = "Baboon, Female, Nonsurgical sterilization, Permanent contraception, Polidocanol",

author = "Jensen, \{Jeffrey T.\} and Carol Hanna and Shan Yao and Cassondra Bauer and Morgan, \{Terry K.\} and Slayden, \{Ov D.\}",

note = "Publisher Copyright: {\textcopyright} 2015 Elsevier Inc.",

year = "2015",

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doi = "10.1016/j.contraception.2015.06.002",

language = "English (US)",

volume = "92",

pages = "96--102",

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T1 - Characterization of tubal occlusion after transcervical polidocanol foam (PF) infusion in baboons

AU - Jensen, Jeffrey T.

AU - Hanna, Carol

AU - Yao, Shan

AU - Bauer, Cassondra

AU - Morgan, Terry K.

AU - Slayden, Ov D.

PY - 2015/8/1

Y1 - 2015/8/1

N2 - Objective Our long-term goal is to develop a nonsurgical method of fallopian tubal occlusion for the purpose of permanent contraception. We have previously demonstrated that transcervical administration of 5% polidocanol foam (PF) can create tubal occlusion in macaques but that multiple treatments are required. In this study, we assessed the efficacy of various regimens of PF with and without depomedroxyprogesterone acetate (DMPA) (to control ovarian cycle phase) in the baboon. Study design Adult cycling female baboons were evaluated for tubal patency by hysterosalpingography and then received a transcervical infusion of PF with (+) or without (-) an intramuscular injection of DMPA (3.5 mg/kg). Two concentrations of PF were compared: 1% [(+) DMPA, n= 5; (-) DMPA, n= 3] and 5% [(+) DMPA, n= 4; (-) DMPA, n= 3]. Controls received (+) DMPA (n= 2) or (-) DMPA, (n= 3) only. The reproductive tracts were removed 1-3 months after treatment for examination. Results No fallopian tubal occlusion was observed in negative controls (± DMPA). Histologic complete tubal occlusion was observed in 3/8 of females treated with 1% PF and in 6/7 treated with 5% PF. Histologic evaluation suggested that 1% PF is associated with prolonged chronic inflammation (more than 2-3 months), while 5% treatment eliminates the epithelial lining, at least focally, and resolves into complete occlusion within 1-2 months. This pattern of complete occlusion was seen in all 4 females that received 5% PF (+ DMPA) and in 2/3 that received 5% PF (- DMPA). Conclusion In a baboon model of transcervical permanent contraception, a single treatment with 5% PF resulted in complete tubal occlusion more reliably (85%) than 1% PF (38%). Cotreatment with DMPA may improve treatment results with 5% PF but requires additional study. Implications A finding that a single transcervical treatment with 5% PF can occlude the fallopian tubes of baboon supports further study of this approach as a novel strategy for permanent contraception for women.

AB - Objective Our long-term goal is to develop a nonsurgical method of fallopian tubal occlusion for the purpose of permanent contraception. We have previously demonstrated that transcervical administration of 5% polidocanol foam (PF) can create tubal occlusion in macaques but that multiple treatments are required. In this study, we assessed the efficacy of various regimens of PF with and without depomedroxyprogesterone acetate (DMPA) (to control ovarian cycle phase) in the baboon. Study design Adult cycling female baboons were evaluated for tubal patency by hysterosalpingography and then received a transcervical infusion of PF with (+) or without (-) an intramuscular injection of DMPA (3.5 mg/kg). Two concentrations of PF were compared: 1% [(+) DMPA, n= 5; (-) DMPA, n= 3] and 5% [(+) DMPA, n= 4; (-) DMPA, n= 3]. Controls received (+) DMPA (n= 2) or (-) DMPA, (n= 3) only. The reproductive tracts were removed 1-3 months after treatment for examination. Results No fallopian tubal occlusion was observed in negative controls (± DMPA). Histologic complete tubal occlusion was observed in 3/8 of females treated with 1% PF and in 6/7 treated with 5% PF. Histologic evaluation suggested that 1% PF is associated with prolonged chronic inflammation (more than 2-3 months), while 5% treatment eliminates the epithelial lining, at least focally, and resolves into complete occlusion within 1-2 months. This pattern of complete occlusion was seen in all 4 females that received 5% PF (+ DMPA) and in 2/3 that received 5% PF (- DMPA). Conclusion In a baboon model of transcervical permanent contraception, a single treatment with 5% PF resulted in complete tubal occlusion more reliably (85%) than 1% PF (38%). Cotreatment with DMPA may improve treatment results with 5% PF but requires additional study. Implications A finding that a single transcervical treatment with 5% PF can occlude the fallopian tubes of baboon supports further study of this approach as a novel strategy for permanent contraception for women.

KW - Baboon

KW - Female

KW - Nonsurgical sterilization

KW - Permanent contraception

KW - Polidocanol

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Characterization of tubal occlusion after transcervical polidocanol foam (PF) infusion in baboons

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