Reproductive performance after the application of hyaluronic acid gel after dilation and curettage in women who have experienced at least one previous curettage: long-term results of a multicenter prospective randomized trial

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Abstract

OBJECTIVE: To examine whether intrauterine application of auto-cross-linked hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive performance.

DESIGN: Multicenter prospective randomized trial.

SETTING: One university and seven university-affiliated teaching hospitals.

PATIENT(S): A total of 149 women who have experienced a miscarriage at <14 weeks of gestation, with at least one previous D&C for miscarriage or termination of pregnancy, were randomly assigned to either D&C plus ACP gel (intervention group) or D&C alone (control group). A hysteroscopy was performed 8-12 weeks after the procedure. Where intrauterine adhesions (IUAs) were found, adhesiolysis was executed.

INTERVENTION(S): Participants received questionnaires 3, 6, and 12 months after the initial D&C procedure with questions regarding menstrual pattern, conception, and reproductive outcome.

MAIN OUTCOME MEASURE(S): Reproductive outcomes during the 12 months after the D&C procedure.

RESULT(S): Outcomes were available for 149 women: 77 in the intervention group and 72 in the control group. The conception rates were, respectively, 71% (46/64) and 59.7% (40/67). There was no significant difference in the miscarriage, ongoing pregnancy, and live birth rates. The median times to conception were 5.5 and 7.1 months, respectively.

CONCLUSION(S): Reproductive performance was similar in both groups although there was a significant difference in the prevalence of IUAs. Given the favorable reproductive outcome in this underpowered study and the fact that adhesiolysis was executed, no solid conclusion can be drawn. Future studies are needed to evaluate the effect of ACP gel on fertility and reproductive outcomes.

CLINICAL TRIAL REGISTRATION NUMBER: NTR 3120.

Original languageEnglish
Pages (from-to)1231-1238
Number of pages8
JournalFertility and Sterility
Volume110
Issue number7
DOIs
Publication statusPublished - Dec 2018

Cite this

@article{246a736837a74ea1a5fc334b3816c5d7,
title = "Reproductive performance after the application of hyaluronic acid gel after dilation and curettage in women who have experienced at least one previous curettage: long-term results of a multicenter prospective randomized trial",
abstract = "OBJECTIVE: To examine whether intrauterine application of auto-cross-linked hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive performance.DESIGN: Multicenter prospective randomized trial.SETTING: One university and seven university-affiliated teaching hospitals.PATIENT(S): A total of 149 women who have experienced a miscarriage at <14 weeks of gestation, with at least one previous D&C for miscarriage or termination of pregnancy, were randomly assigned to either D&C plus ACP gel (intervention group) or D&C alone (control group). A hysteroscopy was performed 8-12 weeks after the procedure. Where intrauterine adhesions (IUAs) were found, adhesiolysis was executed.INTERVENTION(S): Participants received questionnaires 3, 6, and 12 months after the initial D&C procedure with questions regarding menstrual pattern, conception, and reproductive outcome.MAIN OUTCOME MEASURE(S): Reproductive outcomes during the 12 months after the D&C procedure.RESULT(S): Outcomes were available for 149 women: 77 in the intervention group and 72 in the control group. The conception rates were, respectively, 71{\%} (46/64) and 59.7{\%} (40/67). There was no significant difference in the miscarriage, ongoing pregnancy, and live birth rates. The median times to conception were 5.5 and 7.1 months, respectively.CONCLUSION(S): Reproductive performance was similar in both groups although there was a significant difference in the prevalence of IUAs. Given the favorable reproductive outcome in this underpowered study and the fact that adhesiolysis was executed, no solid conclusion can be drawn. Future studies are needed to evaluate the effect of ACP gel on fertility and reproductive outcomes.CLINICAL TRIAL REGISTRATION NUMBER: NTR 3120.",
author = "Hooker, {Angelo B} and {de Leeuw}, {Robert A} and {van de Ven}, {Peter M} and Br{\"o}lmann, {Hans A M} and Huirne, {Judith A F}",
note = "Copyright {\circledC} 2018 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.",
year = "2018",
month = "12",
doi = "10.1016/j.fertnstert.2018.07.021",
language = "English",
volume = "110",
pages = "1231--1238",
journal = "Fertility and Sterility",
issn = "0015-0282",
publisher = "Elsevier Inc.",
number = "7",

}

TY - JOUR

T1 - Reproductive performance after the application of hyaluronic acid gel after dilation and curettage in women who have experienced at least one previous curettage

T2 - long-term results of a multicenter prospective randomized trial

AU - Hooker, Angelo B

AU - de Leeuw, Robert A

AU - van de Ven, Peter M

AU - Brölmann, Hans A M

AU - Huirne, Judith A F

N1 - Copyright © 2018 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

PY - 2018/12

Y1 - 2018/12

N2 - OBJECTIVE: To examine whether intrauterine application of auto-cross-linked hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive performance.DESIGN: Multicenter prospective randomized trial.SETTING: One university and seven university-affiliated teaching hospitals.PATIENT(S): A total of 149 women who have experienced a miscarriage at <14 weeks of gestation, with at least one previous D&C for miscarriage or termination of pregnancy, were randomly assigned to either D&C plus ACP gel (intervention group) or D&C alone (control group). A hysteroscopy was performed 8-12 weeks after the procedure. Where intrauterine adhesions (IUAs) were found, adhesiolysis was executed.INTERVENTION(S): Participants received questionnaires 3, 6, and 12 months after the initial D&C procedure with questions regarding menstrual pattern, conception, and reproductive outcome.MAIN OUTCOME MEASURE(S): Reproductive outcomes during the 12 months after the D&C procedure.RESULT(S): Outcomes were available for 149 women: 77 in the intervention group and 72 in the control group. The conception rates were, respectively, 71% (46/64) and 59.7% (40/67). There was no significant difference in the miscarriage, ongoing pregnancy, and live birth rates. The median times to conception were 5.5 and 7.1 months, respectively.CONCLUSION(S): Reproductive performance was similar in both groups although there was a significant difference in the prevalence of IUAs. Given the favorable reproductive outcome in this underpowered study and the fact that adhesiolysis was executed, no solid conclusion can be drawn. Future studies are needed to evaluate the effect of ACP gel on fertility and reproductive outcomes.CLINICAL TRIAL REGISTRATION NUMBER: NTR 3120.

AB - OBJECTIVE: To examine whether intrauterine application of auto-cross-linked hyaluronic acid (ACP) gel after dilation and curettage (D&C) improves reproductive performance.DESIGN: Multicenter prospective randomized trial.SETTING: One university and seven university-affiliated teaching hospitals.PATIENT(S): A total of 149 women who have experienced a miscarriage at <14 weeks of gestation, with at least one previous D&C for miscarriage or termination of pregnancy, were randomly assigned to either D&C plus ACP gel (intervention group) or D&C alone (control group). A hysteroscopy was performed 8-12 weeks after the procedure. Where intrauterine adhesions (IUAs) were found, adhesiolysis was executed.INTERVENTION(S): Participants received questionnaires 3, 6, and 12 months after the initial D&C procedure with questions regarding menstrual pattern, conception, and reproductive outcome.MAIN OUTCOME MEASURE(S): Reproductive outcomes during the 12 months after the D&C procedure.RESULT(S): Outcomes were available for 149 women: 77 in the intervention group and 72 in the control group. The conception rates were, respectively, 71% (46/64) and 59.7% (40/67). There was no significant difference in the miscarriage, ongoing pregnancy, and live birth rates. The median times to conception were 5.5 and 7.1 months, respectively.CONCLUSION(S): Reproductive performance was similar in both groups although there was a significant difference in the prevalence of IUAs. Given the favorable reproductive outcome in this underpowered study and the fact that adhesiolysis was executed, no solid conclusion can be drawn. Future studies are needed to evaluate the effect of ACP gel on fertility and reproductive outcomes.CLINICAL TRIAL REGISTRATION NUMBER: NTR 3120.

U2 - 10.1016/j.fertnstert.2018.07.021

DO - 10.1016/j.fertnstert.2018.07.021

M3 - Article

VL - 110

SP - 1231

EP - 1238

JO - Fertility and Sterility

JF - Fertility and Sterility

SN - 0015-0282

IS - 7

ER -