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

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

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ORCID for Ying Cheong: orcid.org/0000-0001-7687-4597

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