Condition category
Pregnancy and Childbirth
Date applied
27/07/2016
Date assigned
14/09/2016
Last edited
05/12/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Princess Anne Hospital Southampton

Sponsor details

Coxford Road
SO16 5YA
SO16 5YA
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes

05/12/2016: Publication reference added.