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| 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 |
| 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 |
| 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
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Procedure: ovarian interstitial laser treatment
Different dose of laser: group A, one point per ovary.
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B
14 cases
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Procedure: ovarian interstitial laser treatment
Different dose of laser: group B, two points per ovary.
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C
14 cases
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Procedure: ovarian interstitial laser treatment
Different dose of laser: group c, three points per ovary.
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D
14 Cases
|
Procedure: ovarian interstitial laser treatment
Different dose of laser: group D, four-five points per ovary.
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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 |
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).
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Shen-Zhen City Maternity and Child Healthcare Hospital ( Wen-Jie Zhu ) |
| Study ID Numbers: | 200602070 |
| First Received: | March 11, 2008 |
| Last Updated: | March 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00643708 |
| Health Authority: | China: Ministry of Health |
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