Ovarian Laser Treatment in Women With Polycystic Ovarian Syndrome: A Randomized Study on the Laser Dose
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
1 other identifier
observational
56
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2005
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 11, 2008
CompletedFirst Posted
Study publicly available on registry
March 26, 2008
CompletedMarch 26, 2008
March 1, 2008
2.9 years
March 11, 2008
March 25, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum hormone concentrations,Follicle development and ovulation,Pregnancy and miscarriage
2 months
Secondary Outcomes (1)
Serum hormone concentrations,Follicle development and ovulation,Pregnancy and miscarriage,Adverse effects
6 months
Study Arms (4)
A
14 cases
B
14 cases
C
14 cases
D
14 Cases
Interventions
Different dose of laser: group A, one point per ovary.
Eligibility Criteria
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).
You may qualify if:
- anovulatory women with clomifene citrate (CC)-resistant polycystic ovary syndrome(PCOS)
- A normal hysterosalpingography or laparoscopy had to have been recorded
- infertility
You may not qualify if:
- Any contraindications to surgery
- previous treatment with LOD
- presence of tubal or male factors for infertility
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Zhu W, Chen M, Fu Z, Li X, Qin C, Tang X, Chen X. Repeat transvaginal ultrasound-guided ovarian interstitial laser treatment improved the anovulatory status in women with polycystic ovarian syndrome. Eur J Obstet Gynecol Reprod Biol. 2012 May;162(1):50-4. doi: 10.1016/j.ejogrb.2012.02.008. Epub 2012 Mar 6.
PMID: 22397748DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Wen-Jie Zhu, Master
Shen-Zhen City Maternity and Child Healthcare Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 11, 2008
First Posted
March 26, 2008
Study Start
January 1, 2005
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
March 26, 2008
Record last verified: 2008-03