Abstract
IntroductionPeriadnexal 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.MethodsThis 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.ResultsFifteen 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.ConclusionThe 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 RegistrationISRCTN number, ISRCTN1833588.FundingNordic Pharma.
Highlights
Periadnexal adhesions are known to contribute to subfertility
Periadnexal adhesions contribute to subfertility by a combination of ways, namely by the mechanical distortion of the tubo-ovarian anatomy thereby interfering with the transport of the ovum into the Fallopian tube or the disruption of blood supply to the ovary and its follicular development [1,2,3,4]
Our study suggests that there is no difference between the ovulatory status and endometrial development of women who had the HyalobarrierÒ gel applied intraoperatively versus those who had not, as observed from day 21 progesterone hormonal profile and follicular tracking scans performed at 3 months postoperatively
Summary
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. Adhesion formation/reformation is very common after periovarian adhesiolysis It is not known if the application of HyalobarrierÒ, an anti-adhesion gel, around the adnexal region postsurgery influences ovulatory status. Periadnexal adhesions are adhesions which envelop the fimbriae ends, the Fallopian tubes, and/or ovaries. These adhesions can develop postsurgically, after infection and inflammation secondary to pelvic inflammatory disease or as a consequence of other intra-abdominal infective sources. Periadnexal adhesions contribute to subfertility by a combination of ways, namely by the mechanical distortion of the tubo-ovarian anatomy thereby interfering with the transport of the ovum into the Fallopian tube or the disruption of blood supply to the ovary and its follicular development [1,2,3,4]. Consideration is required for the application of other forms of adhesion prevention agents such as hyaluronic gel-based products
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