Ovarian Laser Treatment in Women With Polycystic Ovarian Syndrome: A Randomized Study on the Laser Dose - Full Text View

Sponsored by:	Shen-Zhen City Maternity and Child Healthcare Hospital
Information provided by:	Shen-Zhen City Maternity and Child Healthcare Hospital
ClinicalTrials.gov Identifier:	NCT00643708

Purpose

BACKGROUND: A new effective way, transvaginal ultrasound-guided ovarian interstitial laser-coagulation treatment, in management of anovulation in patients with polycystic ovary syndrome (PCOS), has been presented in the data published. But, the optimal number of laser coagulation points in the ovarian interstitial to be applied at the procedure is unclear. This clinic trial aims to explore an optimal laser dose for this new protocol. METHODS: Fifty-six PCOS women with clomifene citrate-resistant underwent ultrasound-guided transvaginal ovarian interstitial YAG-laser treatment. By random list table，all subjects were randomly divided into four groups in terms of the number of laser coagulation points made in their ovaries as follows: group A, one coagulation point per ovary; group B, two points; group C, three points; group D, four to five points. The size of each point was about 10 mm in diameter on the ovarian plane monitored by transvaginal ultrasound. Postoperative ovulation rate, pregnancy rate and some biochemical parameters were compared among four groups.

Condition	Intervention	Phase
Anovulation Polycystic Ovary Syndrome Infertility	Procedure: ovarian interstitial laser treatment	Phase III

MedlinePlus related topics: Infertility Ultrasound

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	Transvaginal Ultrasound-Guided Ovarian Interstitial Laser Treatment in Anovulatory Women With Polycystic Ovarian Syndrome: A Randomized Prospective Study on the Effect of Laser Dose Used on the Outcome

Further study details as provided by Shen-Zhen City Maternity and Child Healthcare Hospital:

Primary Outcome Measures:

Serum hormone concentrations,Follicle development and ovulation,Pregnancy and miscarriage [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum hormone concentrations,Follicle development and ovulation,Pregnancy and miscarriage,Adverse effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	56
Study Start Date:	January 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A 14 cases	Procedure: ovarian interstitial laser treatment Different dose of laser: group A, one point per ovary.
B 14 cases	Procedure: ovarian interstitial laser treatment Different dose of laser: group B, two points per ovary.
C 14 cases	Procedure: ovarian interstitial laser treatment Different dose of laser: group c, three points per ovary.
D 14 Cases	Procedure: ovarian interstitial laser treatment Different dose of laser: group D, four-five points per ovary.

Show Detailed Description

Eligibility

Ages Eligible for Study:	23 Years to 34 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Fifty-six patients with anovulatory infertility due to PCOS were included in the study between January 2005 and December 2007. All women presented with oligo-/amenorrhea and anovulation for at least 2 years and were seeking pregnancy. The mean (± SD) age was 29.1 ± 3.1 years and the mean duration of infertility 3.3 ± 2.0 years. The mean body mass index (BMI) was 22.9 ± 3.5 kg/m2. All subjects had polycystic ovaries on transvaginal ultrasound scan (TVS) (Aloka-1000, UST-985, 5 MHz transvaginal probe, Aloka Co. Ltd, Tokyo, Japan), and the diagnosis of PCOS was made according to criteria of The Rotterdam (The Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group, 2003).

Criteria

Inclusion Criteria:

anovulatory women with clomifene citrate (CC)-resistant polycystic ovary syndrome(PCOS)
A normal hysterosalpingography or laparoscopy had to have been recorded
infertility

Exclusion Criteria:

Any contraindications to surgery
previous treatment with LOD
presence of tubal or male factors for infertility

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643708

Sponsors and Collaborators

Shen-Zhen City Maternity and Child Healthcare Hospital

Investigators

Study Chair:

Wen-Jie Zhu, Master

Shen-Zhen City Maternity and Child Healthcare Hospital

More Information

No publications provided

Responsible Party:	Shen-Zhen City Maternity and Child Healthcare Hospital ( Wen-Jie Zhu )
Study ID Numbers:	200602070
Study First Received:	March 11, 2008
Last Updated:	March 25, 2008
ClinicalTrials.gov Identifier:	NCT00643708 History of Changes
Health Authority:	China: Ministry of Health

Keywords provided by Shen-Zhen City Maternity and Child Healthcare Hospital:

anovulation
laser
ovarian interstitial
polycystic ovary syndrome
ultrasound-guided

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Gonadal Disorders
Polycystic Ovary Syndrome
Endocrine System Diseases
Endocrinopathy

Ovarian Diseases
Cysts
Genital Diseases, Male
Anovulation
Ovarian Cysts
Polycystic Ovarian Syndrome

Additional relevant MeSH terms:

Infertility
Disease
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Genital Diseases, Male
Cysts
Adnexal Diseases

Genital Diseases, Female
Neoplasms
Pathologic Processes
Syndrome
Polycystic Ovary Syndrome
Anovulation
Ovarian Cysts

ClinicalTrials.gov processed this record on May 07, 2009