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Randomized controlled trial of Hyalobarrier® versus no Hyalobarrier® on the ovulatory status of women with Periovarian adhesions: a pilot study

Randomized controlled trial of Hyalobarrier® versus no Hyalobarrier® on the ovulatory status of women with Periovarian adhesions: a pilot study
Randomized controlled trial of Hyalobarrier® versus no Hyalobarrier® on the ovulatory status of women with Periovarian adhesions: a pilot study

Introduction: periadnexal 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 periovarian adhesiolysis. It is not known if the application of Hyalobarrier®, an anti-adhesion gel, around the adnexal region postsurgery influences ovulatory status. The study is a pilot randomized controlled trial (RCT) randomizing women into the application of Hyalobarrier® versus no Hyalobarrier® at the time of laparoscopy, where postsurgical ovulatory status and pregnancy rates were evaluated.

Methods: this was a pilot RCT where women were recruited from the gynecological and subfertility clinic who were deemed to require an operative laparoscopy. If intraoperatively they were found to have periovarian adhesions, they were randomized 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® were recorded. Prior to the surgery and postoperatively, the participants had their serum hormonal status (day 2 FSH, LH and day 21 progesterone) evaluated. Postoperatively, they underwent a follicular tracking cycle at 3 months.

Results: fifteen women were randomized into use of Hyalobarrier® (study group) and 15 into the no Hyalobarrier® group (control group) between December 2011 and January 2014. There was no difference in the patient characteristics in terms of age, BMI, the number of previous pregnancies, or 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 day 21 progesterone) before or after surgery. The 3-month postoperative day 10-12 follicular tracking findings and endometrial thickness were similar between the study and control groups. Four women were pregnant in the study group (24%) and one in the control group (7%) cumulatively over 2 years.

Conclusions: 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 postsurgery.

Trial registration: ISRCTN number, ISRCTN1833588.

Funding: Nordic Pharma.

Adnexal Diseases, Adult, Female, Gels, Humans, Hyaluronic Acid, Laparoscopy, Ovulation, Pilot Projects, Pregnancy, Tissue Adhesions, Journal Article, Randomized Controlled Trial
0741-238X
199-206
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) Randomized controlled trial of Hyalobarrier® versus no Hyalobarrier® on the ovulatory status of women with Periovarian adhesions: a pilot study. Advances in Therapy, 34 (1), 199-206. (doi:10.1007/s12325-016-0453-z).

Record type: Article

Abstract

Introduction: periadnexal 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 periovarian adhesiolysis. It is not known if the application of Hyalobarrier®, an anti-adhesion gel, around the adnexal region postsurgery influences ovulatory status. The study is a pilot randomized controlled trial (RCT) randomizing women into the application of Hyalobarrier® versus no Hyalobarrier® at the time of laparoscopy, where postsurgical ovulatory status and pregnancy rates were evaluated.

Methods: this was a pilot RCT where women were recruited from the gynecological and subfertility clinic who were deemed to require an operative laparoscopy. If intraoperatively they were found to have periovarian adhesions, they were randomized 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® were recorded. Prior to the surgery and postoperatively, the participants had their serum hormonal status (day 2 FSH, LH and day 21 progesterone) evaluated. Postoperatively, they underwent a follicular tracking cycle at 3 months.

Results: fifteen women were randomized into use of Hyalobarrier® (study group) and 15 into the no Hyalobarrier® group (control group) between December 2011 and January 2014. There was no difference in the patient characteristics in terms of age, BMI, the number of previous pregnancies, or 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 day 21 progesterone) before or after surgery. The 3-month postoperative day 10-12 follicular tracking findings and endometrial thickness were similar between the study and control groups. Four women were pregnant in the study group (24%) and one in the control group (7%) cumulatively over 2 years.

Conclusions: 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 postsurgery.

Trial registration: ISRCTN number, ISRCTN1833588.

Funding: Nordic Pharma.

Text
10.1007_s12325-016-0453-z - Version of Record
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More information

Accepted/In Press date: 14 October 2016
e-pub ahead of print date: 29 November 2016
Keywords: Adnexal Diseases, Adult, Female, Gels, Humans, Hyaluronic Acid, Laparoscopy, Ovulation, Pilot Projects, Pregnancy, Tissue Adhesions, Journal Article, Randomized Controlled Trial

Identifiers

Local EPrints ID: 417129
URI: http://eprints.soton.ac.uk/id/eprint/417129
ISSN: 0741-238X
PURE UUID: 0f993503-9f74-46b2-b775-d9dc205055e0
ORCID for Ying Cheong: ORCID iD orcid.org/0000-0001-7687-4597

Catalogue record

Date deposited: 19 Jan 2018 17:30
Last modified: 07 Oct 2020 01:54

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