The University of Southampton
University of Southampton Institutional Repository

Randomised controlled trial of Hyalobarrier® versus no Hyalobarrier® on the ovulatory status of women with peri-ovarian adhesions: a pilot study

Randomised controlled trial of Hyalobarrier® versus no Hyalobarrier® on the ovulatory status of women with peri-ovarian adhesions: a pilot study
Randomised controlled trial of Hyalobarrier® versus no Hyalobarrier® on the ovulatory status of women with peri-ovarian adhesions: a pilot study
Introduction: Peri-adnexal adhesions are known to contribute to subfertility. The restoration of the tubo-ovarian anatomy is one the key principles in reproductive surgery, and this involves adhesiolysis. However, adhesion formation/reformation is very common after peri-ovarian adhesiolysis. It is not known if the application of Hyalobarrier®, an anti-adhesion gel around the adnexal post-surgery influence ovulatory status. The study is a randomised controlled pilot study (RCT) randomising women into the application of Hyalobarrier® versus no Hyalobarrier® at the time of laparoscopy, where post-surgical ovulatory status and pregnancy rates were evaluated.

Methods: This was a pilot randomised controlled trial where women were recruited from the gynaecological and subfertility clinic who were deemed to require an operative laparoscopy. If intra-operatively they were found to have peri-ovarian adhesions, they were randomised into having adhesiolysis with and without usage of Hyalobarrier®. Demographic details and intraoperative details including the severity, extent and the ease of use of Hyalobarrier® was recorded. Prior to the surgery, and post operatively, the participants had their serum hormonal status (Day 2 FSH, LH and Day 21 progesterone) evaluated. Post operatively, they underwent a follicular tracking cycle at 3 months.

Results: 15 women were randomised into use of Hyalobarrier® (study group), 15 into the no Hyalobarrier® group (control group) between December 2011- January 2014. There was no difference in the patient characteristics in terms of age, BMI, the number of previous pregnancies, the extent, site and severity of adhesions between the two groups. There was no significant difference between the study versus control groups in terms of the hormonal profile (Day 2 FSH and D21 progesterone) before or after surgery. The 3-month post-operative Day 10-12 follicular tracking findings and endometrial thickness were similar between the study and control groups. Four women in the study group (24%) and one in the control group were pregnant cumulatively over 2 years. All the pregnant patients were randomised into the Hyalobarrier® group. The majority of surgeons reported that the Hyalobarrier® Gel Endo was easy to apply.

Conclusion: The use of Hyalobarrier® post salpingo-ovariolysis did not influence follicular development as inferred from the results of the Day 21 progesterone and folliculogram on Day 10-12 3-month post-surgery
0741-238X
1-12
Cheong, Ying
4efbba2a-3036-4dce-82f1-8b4017952c83
Bailey, Sarah
f9e7aa1b-4b6f-47c8-a8cb-afb40d6d5f5e
Forbes, Jane
1d713a67-18e5-4e09-8940-c844ee046103
Cheong, Ying
4efbba2a-3036-4dce-82f1-8b4017952c83
Bailey, Sarah
f9e7aa1b-4b6f-47c8-a8cb-afb40d6d5f5e
Forbes, Jane
1d713a67-18e5-4e09-8940-c844ee046103

Cheong, Ying, Bailey, Sarah and Forbes, Jane (2016) Randomised controlled trial of Hyalobarrier® versus no Hyalobarrier® on the ovulatory status of women with peri-ovarian adhesions: a pilot study. Advances in Therapy, 1-12. (In Press)

Record type: Article

Abstract

Introduction: Peri-adnexal adhesions are known to contribute to subfertility. The restoration of the tubo-ovarian anatomy is one the key principles in reproductive surgery, and this involves adhesiolysis. However, adhesion formation/reformation is very common after peri-ovarian adhesiolysis. It is not known if the application of Hyalobarrier®, an anti-adhesion gel around the adnexal post-surgery influence ovulatory status. The study is a randomised controlled pilot study (RCT) randomising women into the application of Hyalobarrier® versus no Hyalobarrier® at the time of laparoscopy, where post-surgical ovulatory status and pregnancy rates were evaluated.

Methods: This was a pilot randomised controlled trial where women were recruited from the gynaecological and subfertility clinic who were deemed to require an operative laparoscopy. If intra-operatively they were found to have peri-ovarian adhesions, they were randomised into having adhesiolysis with and without usage of Hyalobarrier®. Demographic details and intraoperative details including the severity, extent and the ease of use of Hyalobarrier® was recorded. Prior to the surgery, and post operatively, the participants had their serum hormonal status (Day 2 FSH, LH and Day 21 progesterone) evaluated. Post operatively, they underwent a follicular tracking cycle at 3 months.

Results: 15 women were randomised into use of Hyalobarrier® (study group), 15 into the no Hyalobarrier® group (control group) between December 2011- January 2014. There was no difference in the patient characteristics in terms of age, BMI, the number of previous pregnancies, the extent, site and severity of adhesions between the two groups. There was no significant difference between the study versus control groups in terms of the hormonal profile (Day 2 FSH and D21 progesterone) before or after surgery. The 3-month post-operative Day 10-12 follicular tracking findings and endometrial thickness were similar between the study and control groups. Four women in the study group (24%) and one in the control group were pregnant cumulatively over 2 years. All the pregnant patients were randomised into the Hyalobarrier® group. The majority of surgeons reported that the Hyalobarrier® Gel Endo was easy to apply.

Conclusion: The use of Hyalobarrier® post salpingo-ovariolysis did not influence follicular development as inferred from the results of the Day 21 progesterone and folliculogram on Day 10-12 3-month post-surgery

Text
__userfiles.soton.ac.uk_Users_nl2_mydesktop_Deposits_One off_RCT of hyalobarrier versus no hyalobarrier on the ovulatory status of wo....docx - Accepted Manuscript
Download (253kB)

More information

Accepted/In Press date: 15 November 2016
Organisations: Human Development & Health

Identifiers

Local EPrints ID: 402910
URI: http://eprints.soton.ac.uk/id/eprint/402910
ISSN: 0741-238X
PURE UUID: a28696b2-e8ba-424a-b0a9-e33cbd6f20ae
ORCID for Ying Cheong: ORCID iD orcid.org/0000-0001-7687-4597

Catalogue record

Date deposited: 18 Nov 2016 12:00
Last modified: 18 Feb 2021 17:11

Export record

Contributors

Author: Ying Cheong ORCID iD
Author: Sarah Bailey
Author: Jane Forbes

University divisions

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×