How does hyalobarrier gel influence ovulation and pregnancy outcomes in women with scarring around the tubes and ovaries?
| ISRCTN | ISRCTN18335881 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18335881 |
| Secondary identifying numbers | 11/H0504/6 |
- Submission date
- 27/07/2016
- Registration date
- 14/09/2016
- Last edited
- 05/12/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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
Contact information
Scientific
Human Development and Health
University of Southampton Faculty of Medicine
Level F
Princess Anne Hospital
Coxford Road
Southampton
SO16 5YA
United Kingdom
 ORCID ID |
0000-0001-7687-4597 |
|---|---|
| Phone | +44 (0)2380 216033 |
| y.cheong@soton.ac.uk |
Study information
| Study design | Randomised controlled pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Randomsied controlled trial of hyalobarrier versus no hyalobarrier on the ovulatory status of women with peri-ovarian adhesions: a pilot study |
| Study objectives | 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(s) | South Central Hampshire A Ethics Committee, 13/01/2011, ref: 11/H0504/6 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2011 |
| Completion date | 01/11/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 38 Years |
| Sex | Female |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Aged between 18-38 2. Women were undergoing operative laparoscopy for gynaecological pathology, with possible peri-ovarian adhesions |
| Key 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) |
| Date of first enrolment | 01/02/2012 |
| Date of final enrolment | 01/02/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Southampton
So16 5YA
United Kingdom
Sponsor information
Hospital/treatment centre
Coxford Road
SO16 5YA
SO16 5YA
England
United Kingdom
"ROR" |
https://ror.org/02yjksy18 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/11/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal within 3 years from the trial completion date. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2017 | Yes | No |
Editorial Notes
05/12/2016: Publication reference added.
