Plain English Summary
Background and study aims
An adhesion is a type of scar tissue that can make the tissues or organs inside the body stick together. This type of scarring is often caused by undergoing a laproscopy (a type of operation in which the surgeon accesses the inside of the abdomen (tummy) or pelvis through a small cut. If the adhesions are around the fallopian tubes and ovaries, it can reduce fertility, as it can interfere with the monthly release of an egg necessary for conception. The removal of scarring using an anti-scarring gel is potentially useful for stopping scars from reforming after surgery. But it is not known if the gel will influence ovulation (egg production) monthly. The aim of this study is to find out whether using an anti-scarring gel called Hyalobarrier after a laproscopy has an effect on the function of ovaries.
Who can participate?
Women aged between 18 and 28 who are undergoing a laproscopy for the treatment of a condition relating to the female reproductive system, who have possible
What does the study involve?
Participants are randomly allocated to one of two groups. Both groups undergo a laproscopy according to standard procedure, but those in the first group have 10ml hyalobarrier applied around the operative site. Participants have levels of reproductive hormones measured at the start of the study and then again after three and six months, as well as undergoing ultrasound scanning at the same times to monitor their egg production.
What are the possible benefits and risks of participating?
There are no direct benefits or risks involved for participants taking part in this study.
Where is the study run from?
Princess Anne Hospital, Southampton (UK)
When is the study starting and how long is it expected to run for?
November 2011 to November 2014
Who is funding the study?
Nordic Pharma Ltd. (UK)
Who is the main contact?
Professor Ying Cheong
y.cheong@soton.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Ying Cheong
ORCID ID
http://orcid.org/0000-0001-7687-4597
Contact details
Human Development and Health
University of Southampton Faculty of Medicine
Level F
Princess Anne Hospital
Coxford Road
Southampton
SO16 5YA
United Kingdom
+44 (0)2380 216033
y.cheong@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
11/H0504/6
Study information
Scientific title
Randomsied controlled trial of hyalobarrier versus no hyalobarrier on the ovulatory status of women with peri-ovarian adhesions: a pilot study
Acronym
Study hypothesis
The aim of this study is to compare the ovarian function of women who have peri-ovarian adhesiolysis with and without Hyalobarrier as an anti-adhesion barrier.
Ethics approval
South Central Hampshire A Ethics Committee, 13/01/2011, ref: 11/H0504/6
Study design
Randomised controlled pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Adnexal adhesions
Intervention
Participants are randomised to one of two groups using a computer generated random numbers table and opaque envelopes.
Intervention group: Participants receive hyalobarrier get at laparoscopy. This involves having 10ml hyalobarrier applied around the operative site was applied as per manufacturer’s instruction.
Control group: Participants receive no hyalobarrier gel at laparoscopy.
Follow up for all participants involves hormonal profiling (Day 2/3 FSH and LH, and Day 21 progesterone) plus follicular tracking using ultrasonography at month 3 and month 6 post operatively.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measures
Ovulatory status is measured using serum hormonal status (Day 2 FSH, LH and Day 21 progesterone) prior to the surgery and at 3 and 6 months after the surgery. Post-operatively, the participant will also undergo a follicular tracking cycle at 3 and 6 months.
Secondary outcome measures
Clinical pregnancy is measured by the presence of a fetal heart at 5-6 weeks gestation.
Overall trial start date
01/11/2011
Overall trial end date
01/11/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged between 18-38
2. Women were undergoing operative laparoscopy for gynaecological pathology, with possible peri-ovarian adhesions
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
30
Participant exclusion criteria
1. Presence of malignancies or a history of malignancies
2. Women on medications that affected ovulation
3. Women with known conditions that resulted in anovulation (PCOS, Pituitary causes)
Recruitment start date
01/02/2012
Recruitment end date
01/02/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Princess Anne Hospital
Coxford Road
Southampton
So16 5YA
United Kingdom
Funders
Funder type
Industry
Funder name
Nordic Pharma Ltd.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal within 3 years from the trial completion date.
Intention to publish date
01/11/2017
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27900662