• Title/Summary/Keyword: safety efficacy

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Vinorelbine Monotherapy on Advanced Non-small Cell Lung Cancer (진행성 비소세포폐암 환자에서 Vinorelbine의 단독요법)

  • Kim, Myung-Hoon;Park, Hee-Sun;An, Jin-Yong;Kwon, Sun-Jung;Lee, Yun-Sun;Jeong, Sung-Su;Kim, Ju-Ock;Kim, Sung-Young
    • Tuberculosis and Respiratory Diseases
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    • v.52 no.5
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    • pp.475-484
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    • 2002
  • Background : Unresectable non-small cell lung cancer has a poor response to chemotherapy and has an unfortunate prognosis. More effective and less toxic cytotoxic agents are needed to improve the outcome of these patients. The efficacy and safety of vinorelbine monotherapy in these advanced lung cancer patients was evaluanted. Materials and Methods : Sixteen patients with non-small cell lung cancer in stage III or IV, who received vinorelbine alone as an initial anticancer chemotherapy from June 1996 to December 2000 were enrolled in this study. Vinorelbine was given intravenously at a dose 30mg/$m^2$ every week. Results : A mong the sixteen patients, six had a partial response(38%) and the median survival was 16 weeks. The median response duration was 27 weeks (95% CI 6-47), and the time to progression was 16 weeks(95% CI 6-26). Among a total of 112 cycles, neutropenia(WHO grade 3 or 4) and anemia(grade 3) occurred in 9% and 3%, respectively. Only 1 patient required hospitalization for neutropenic fever. Non-hematologic toxicity was minor and was easily controlled. Conclusion : Vinorelbine monotherapy was well tolerated, and moderately effective in patients with advanced non-small cell lung cancer.

Comparisons of 12-Hour and 24-Hour Sustained-Release Theophyllines in the Management of Asthma (천식치료에서 서방형 Theophylline의 1일 1회 제형과 1일 2회 제형의 비교)

  • Lee, Yang-Deok;Park, Seoung-Ju;Lee, Heung-Bum;Lee, Yong-Chul;Rhee, Yang-Keun
    • Tuberculosis and Respiratory Diseases
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    • v.50 no.3
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    • pp.293-299
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    • 2001
  • Background : Sustained-release theophylline, which is generally prescribed as a twice-daily equal-dose regimen, is one of the more common asthma treatments. The development of a sustained-release drug delivery technology that enables improved control of the theophylline blood levels represents a significant advancement in both the efficacy and safety of dosing. Method : A crossover study was conducted with 25 adult chronic asthmatic patients requiring daily bronchodilator therapy. The study group included thirteen males and twelve females with ages ranging from 19 to 71 years. The overall approach was to place the patients first on the twice-daily preparation($Etheophyl^{(R)}$) for 28 days at 8 AM and 8 PM, and measure the pulmonary function and theophylline level on the 28th day. The patients were subsequently switched to the once-daily preparation($Uniphyl^{(R)}$) in the same daily dose at 8 PM on the 29th day and the same parameters were measured on the 56th day. Results : The mean serum levels of theophylline were $8.18{\pm}1.66\;{\mu}g/ml$ in the $Etheophyl^{(R)}$-treated period and $8.00{\pm}1.75\;{\mu}g/ml$ in the $Uniphyl^{(R)}$-treated period. ln addition, the $FEV_1$ showed $71.40{\pm}7.48$ percent in the $Etheophyl^{(R)}$-treated and $69.18{\pm}9.00$ percent in the $Uniphyl^{(R)}$-treated period. Thus there were no significant differences between the once-daily and twice-daily preparation. Conclusion : The results indicated little clinical differences between the two medications. The two drugs are equally effective in controlling asthma over the four weeks of treatment.

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Safety and Efficacy of Early Treatment with Intravenous Immunoglobulin in Patients with Kawasaki Disease (가와사끼병에서 면역글로불린 조기치료의 안전성과 효과)

  • Kim, Hyun Jin;Yom, Hae Won;Kim, Hae Soon;Sohn, Sejung
    • Clinical and Experimental Pediatrics
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    • v.46 no.10
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    • pp.1019-1023
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    • 2003
  • Purpose : To determine the differences in clinical characteristics, blood chemistry and coronary artery complications between patients with Kawasaki disease who received intravenous immunoglobulin (IVIG) within the fourth day of illness and after the fifth day of illness. Methods : A retrospective chart review was conducted of all children with Kawasaki disease who were admitted to Ewha Mokdong Hospital between January 2001 and June 2002. The early treatment group received IVIG within the fourth day of illness(n=34) and the control group received IVIG after the fifth day of illness(n=53). Clinical manifestations, fever duration, hospitalization days, CBC, blood chemistry and coronary artery complications were compared between two groups. Results : No demographic differences were noted between the two groups(P>0.05). Total duration of fever was significantly shorter in the early treatment group than the control group($4.8{\pm}2.5days$ vs $7.4{\pm}3.0days$, P<0.05), but there were no differences in fever duration after IVIG treatment and hospitalization days between two groups(P>0.05). No significant differences were noted in the level of hemoglobin, WBC, ESR, CRP, AST, ALT and albumin between two groups(P>0.05). No significant differences in the incidence of IVIG retreatment were noted between the two groups(11.8% vs 5.7%, P>0.05). No significant differences in the incidence of coronary artery complications were noted between the two groups(11.7% vs 18.9%, P>0.05). No significant differences in the recurrence rate were noted between the two groups(3% vs 2%, P>0.05). Conclusion : Early IVIG treatment in patients with Kawasaki disease reduces the total fever duration. Coronary artery complications were not increased in patients with early IVIG treatment.

Use of Undiluted Potassium Solution in Intermittent Antegrade Warm Blood Cardioplegia (IAWBC) (간헐적 전방온혈심정지액에서 희석되지 않은 고농도 포타슘의 사용)

  • 백완기;손국희;김영삼;윤용한;김혜숙;임현경;이춘수;김광호;김정택
    • Journal of Chest Surgery
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    • v.37 no.8
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    • pp.660-664
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    • 2004
  • Background: Dilution of blood cardioplegia is not needed in IAWBC as it is in cold blood cardioplegia because it does not aggregate red blood cells on normal body temperature and does not compromise micro coronary circulation. This study was designed to evaluate the safety and efficacy of undiluted potassium solution in IAWBC. Material and Method: Thirty patients who underwent CABG with IAWBC were grouped into dilutedplegia (n=14) and microplegia (n=16). Potassium was delivered conventionally with 4 : 1 delivery kit in the dilutedplegia group. The undiluted potassium was directly connected on the blood of oxygenator in the microplegia group. Result: There were no differences in sex, age, left ventricular ejection fraction, number of grafts, aortic cross clamping time, and the value of perioperative myocardial enzyme between the two groups. There were no perioperative myocardial infarction and hospital mortality. The amount of crystalloid cardioplegia was 1346$\pm$597 mL in dilutedplegia (mean$\pm$standard deviation, and 28$\pm$9 mL in microplegia (p<0.0001). The hematocrit during cardiopulmonary bypass was 21$\pm$4% in dilutedplegia and 24$\pm$3% in microplegia (p>0.05). 11 patients in dilultedplegia received blood transfusion, but 4 patients in microplegia received blood transfusion (p<0.05). The amount of urine and hemofiltration during the operation were more in dilutedplegia (1250$\pm$810 mL, 1689$\pm$548 mL) than in microplegia (959$\pm$410 mL, 1461$\pm$784 mL; p<0.05). Conclusion: The undiluted potassium of IAWBC in CABG operation is a safe, effective technique for myocardial protection to prevent fluid overload, and blood transfusion. There is no need to use the delivery kit.

Development of Indicators to Assess the Quality of Ubiquitous-Ecological Cities (유비쿼터스 에코시티 평가지표 개발 및 적용 연구)

  • Kim, Han-Saem;Jeong, Yeun-Woo
    • Land and Housing Review
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    • v.2 no.2
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    • pp.111-123
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    • 2011
  • A Ubiquitous-Ecological City (U-Eco City) is the new urban paradigm integrated with ubiquitous-city (U-City) connecting the high-tech IT technology to the urvan space with the concept of the sustainable eco-city. As a U-Eco City is attempted for the first time domestically and internationally, there is insufficient discussions for its develoment goal, planned design proposal, technology and service element and others. Even if there are plans to build up it, policy and technology, service structuring business and others, it is difficult to assess how it would bring the efficacy. Therefore, the purpose of this study is to present the indicators system to assess a U-Eco City. The results of this study revealed the following; First, the conceptual framework, which was established to achieve sustainable urban quality, can be suggested by establishing its notion of the U-Eco City. The concept of a U-Eco City as established in this study suggests that the economic development in growth-oriented level has to be conducted not only quality of urban environment but also in terms of sustainable to consider the complex impact of various development; Secondly, the developed assessment system has heightened the completeness as the evaluation index through the attitude survey. As a result of questionnaire survey with the subject of specialists and interested party of this study, the urban qualitative aspect is formulated for the stability as a relatively important aspect. For the urban continuity aspect, society, environment and economy have all similar importance, but the environment element was shown to be highest. And finally, subject area was selected on the basis of the evaluation system and the analysis was made on the basis of the implementation design plan of the area. As a result of the assessment, safety and economy have shown to be high. This is indirectly indicated for the priority in economic growth driven development plan unlike the importance of environmental continuity obtained through the attitude survey. When planning on urban development, there is a need for supplementing the environment part and it has to present the connection plan between the economic growth and environmental continuity.

Frameless Fractionated Stereotactic Radiaton Therapy in Recurrent Head & Neck Cancers (국소재발된 두경부종양의 무고정틀 정위적 분할방사선치료)

  • Kim In-Ah;Choi Ihl-Bhong;Jang Ji-Young;Kang Ki-Mun;Jho Seung-Ho;Kim Hyung-Tae;Lee Kyung-Jin;Choi Chang-Rak
    • Korean Journal of Head & Neck Oncology
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    • v.14 no.2
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    • pp.156-163
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    • 1998
  • Background & Objectives: Frameless fractionated stereotactic radiotherapy(FFSRT) is a modification of stereotactic radiosurgery(SRS) with radiobiologic advantage of fractionation without losing mechanical accuracy of SRS. Local recurrence of head and neck cancer at or near skull base benefit from reirradiation. Main barrier to successful palliation is dose limitation secondary to normal tissue tolerance. We try to evaluate the efficacy and safety of FFSRT as a new modality of reirradaton in these challenging patients. Materials & Methods: Seven patients with recurrent head & neck cancer involving at or near skull base received FFSRT from September 1995 to November 1997. Six patients with nasopharyngeal cancer had received induction chemotherapy and curative radiation therapy. One patient with maxillary sinus cancer had received total maxillectomy and postoperative radiation therapy as a initial treatment. Follow-up ranged from 11 to 32 months with median of 24 months. Three of 7 patients received hyperfractionated radiation therapy(1.1-1.2Gy/fraction, bid, total 19.8-24Gy) just before FFSRT. All patients received FFSRT(3-5Gy/fraction, total 15-30Gy/5-10fractions). Chemotherapy(cis-platin $100mg/m^2$) were given concurrently with FFSRT in four patients. Second course of FFSRT were given in 4 patients with progression or recurrence after initial FFSRT. Because IF(irregularity factor; ratio of surface area of target to the surface area of sphere with same volume as a target) is too big to use conventional stereotactic RT using multiple arc method for protection of radiation damage to critical normal tissue, all patients received FFSRT with conformal method using irregular static ports. Results: Five of 7 patients showed complete remission in follow-up CT &/or MRI. Three of these five patients who developed marginal, in-field, and out-field recurrences, respectively. Another one of complete responders has been dead of G-I bleeding without evidence of local recurrence. One partial responder who showed progressive disease 15 months after initial FFSRT has received additional FFSRT, and then he is well-being with symptomatic improvement. One minmal responder who showed progression of locoregional disease 9 months after $1^{st}$ FFSRT has received 2nd FFSRT, and then he is alive with stable disease. Five of 7 case had showed direct invasion to skull base and had complaint headache and various symptoms of cranial nerve involvement. Four of these five case showed improvement of neurologic symptoms after FFSRT. No significant neurologic complicaltion related to FFSRT was observed during follow-up periods. Tumor volumes were ranged from 3.9 to 50.7 cc and surface area ranged from 16.1 to $114.9cm^2$. IF ranged from 1.21 to 1.74. The average ratio of volume of prescription isodose shell to target volume was 1.02 that indicated the improvement of target coverage and dose distribution with FFSRT with conformal method compared to target coverage with FFSRT with multiple arc method. Conclusion: Our initial experience suggests that FFSRT with conformal method was relatively effective and safe modality in the treatment of recurrent head and neck cancer involving at or near skull base. Treatment benefit included good palliation of symptoms and reasonable radiographic response. However, more experience and additional follow-up are needed to better assess its ultimate role in treating these challenging patients.

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Comparison of Effect Between Thrombolysis and Anticoagulation in Major Pulmonary Thromboembolism (쇽 혹은 우심실부전을 보이는 중증 폐혈전색전증에서 혈전용해요법과 항응고요법의 효과)

  • Han, Song Yi;Song, Jae Kwan;Lee, Sang Do;Lim, Chae-Man;Koh, Younsuck;Park, Chan Sun;Oh, Yeon Mok;Shim, Tae Sun;Kim, Woo Sung;Kim, Dong Soon;Kim, Won Dong;Hong, Sang-Bum
    • Tuberculosis and Respiratory Diseases
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    • v.59 no.5
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    • pp.487-496
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    • 2005
  • Background : 'Major pulmonary thromboembolism' is defined as right ventricular (RV) dysfunction, with or without shock, accompanied by significant morbidity and mortality. In this study, those with major pulmonary thromboembolism were divided into the shock and RV dysfunction only groups, and then investigated the mortality and complications in thrombolysis or anticoagulation, respectively. Methods : In a retrospective study, between January 1995 and December 2004, 60 eligible patients with a major pulmonary thromboembolism, admitted in Asan Medical Center, were included. Results : A total of 57 patients were treated with medical therapy. Thrombolysis was performed in 13 patients (23%) and anticoagulation in 44 (77%). There were no differences in the APACHEII and SOFA scores between the two groups. 6 (46%) and 11 (25%) patients died in the thrombolysis and anticoagulation groups, respectively (p=0.176). In the 19 patients (33%) showing shock, thrombolysis was performed in 9 (47%) and anticoagulation in 10 (53%). 4 (44%) of the 9 patients treated with thrombolytic agents and 3 (30%) of the 10 treated with anticoagulants died (p=0.650). In the 38 patients (67%) showing RV dysfunction only, thrombolysis was performed in 4 (11%) and anticoagulation in 34 (89%). 2 (50%) of the 4 patients treated with thrombolytics and 8 (24%) of the 34 treated with anticoagulants died (p=0.279). Three patients (23%) who underwent thrombolysis had a major bleeding episode, compared with 2 (5%) who were treated with anticoagulants (p=0.072). Conclusion: The results of our study showed that thrombolysis did not lower mortality and tended to increase major bleeding compared with anticoagulation in both the shock and RV dysfunction only groups. Further evaluation of the efficacy and safety of thrombolytic therapy for major thromboembolism appears warranted in Korea.

Comparison of Clinical Efficacy Between Percutaneous Dilatational Tracheostomy and Surgical Tracheostomy (경피적 확장 기관절개술 (Percutaneous Dilatational Tracheostomy)의 시술 용이성 및 합병증)

  • Ahn, Jong-Joon;Koh, Youn-Suck;Chin, Jae-Yong;Lee, Ki-Man;Park, Wann;Hong, Sang-Bum;Shim, Tae-Sun;Lee, Sang-Do;Kim, Woo-Sung;Kim, Dong-Soon;Kim, Won-Dong;Lim, Chae-Man
    • Tuberculosis and Respiratory Diseases
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    • v.45 no.6
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    • pp.1277-1283
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    • 1998
  • Background : Surgical tracheostomy(ST) is usually performed by surgeons in operating room. For a patient with mechanical ventilation, however, transportation to operating room for ST could be dangerous for patients. In addition, ST is often delayed due to unavailability of operating room or surgeon. Percutaneous dilatational tracheostomy(PDT), although novel in Korea, is gaining popularity as a bedside procedure in the hospitals of western countries. We evaluated the technical ease and safety of PDT in comparison with ST. Method : Thirty-eight patients in medical intensive care unit (ICU) who were either under mechanical ventilation for more than 7 days or required airway protection, were randomly assigned to ST(18 patients) or PDT(20 patients). Between two groups, there was no significant clinical difference except that female to male ratio was higher in the ST group. ST was performed by second year residents of the department of otolaryngology while PDT was performed by third grade medical resident and pulmonologist under bronchoscopic guide using Ciaglia Percutaneous Tracheostomy Set(Cook Critical Care, Bloomington, USA) in medical ICU. The following factors were compared between two groups : number of delayed cases after the decision for tracheostomy, procedural time, complications related to tracheostomy. Results : Delayed cases were 11 in ST group and 3 in PDT group (P<0.05). Procedural time was significantly shorter in PDT group ($15.6{\pm}7.1min$) than in ST group ($29.1{\pm}11.6min$, P<0.0001). Complications related to tracheostomy occurred in 5 cases in ST group : accidental decannulation (1), subcutaneous emphysema (2) and minor bleeding (2), and in 4 cases in PDT group : minor bleeding (2), subcutaneous emphysema (1) and premature extubation (1) (P>0.05). Conclusion : Since percutaneous dilatational tracheostomy was easy to practice and its complications were not different from surgical tracheostomy, PDT can be a useful bedside procedure for mechanically ventilated patients.

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NEW ANTIDEPRESSANTS IN CHILD AND ADOLESCENT PSYCHIATRY (소아청소년정신과영역의 새로운 항우울제)

  • Lee, Soo-Jung
    • Journal of the Korean Academy of Child and Adolescent Psychiatry
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    • v.14 no.1
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    • pp.12-25
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    • 2003
  • Objectives:As increasing number of new antidepressants have been being introduced in clinical practice, pharmacological understanding has been broadened. These changes mandate new information and theories to be incorporated into the treatment process of children with depressive disorders. In light of newly coming knowledge, this review intended to recapitulate the characteristics of new antidepressants and to consider the pivotal issues to develope guidelines for the treatment of depression in childhood and adolescence. Methods:Searching the Pub-Med online database for the articles with the key words of 'new', 'antidepressants' and 'children' ninety-seven headings of review articles were obtained. The author selected the articles of pertinent subjects in terms of either treatment guideline or psychopharmacology of new antidepressants. When required, articles about the clinical effectiveness of individual antidepressants were separatedly searched. In addition, the safety information of new antidepressants was acquired by browsing the official sites of the United States Food and Drugs Administration and Department of Health and Human Services. Results:1) For the clinical course, treatment phase, and treatment outcome, the reviews or treatment guidelines adopted the information from adult treatment guidelines. 2) Systematic and critical reviews unambiguously concluded that selective serotonin reuptake inhibitors(SSRIs) excelled tricyclic antidepressants( TCAs) for both efficacy and side effect profiles, and were recommend for the first-line choice for the treatment of children with depressive disorders. 3) New antidepressants generally lacked treatment experiences and randomized controlled clinical trials. 4) SSRIs and other new antidepressants, when used together, might result in pharmacokinetic and/or pharmacodynamic drug-to-drug interaction. 5) The difference of the clinical effectiveness of antidepressants between children and adults should be addressed from developmental aspects, which required further evidence. Conclusion:Treatment guidelines for the pharmacological treatment of childhood and adolescence depression could be constructed on the basis of clinical trial findings and practical experiences. Treatment guidelines are to best serve as the frame of reference for a clinician to make reasonable decisions for a particular therapeutic situation. In order to fulfill this role, guidelines should be updated as soon as new research data become available.

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COH-IVF Outcomes for Infertile Patients With Borderline Ovarian Tumor After Conservative Treatment (경계성 난소 종양의 보존적 수술 후 불임 환자에서 체외수정시술의 유용성)

  • Lee, Hyun-Joo;Ahn, Ka-Yougng;Hahn, Ho-Suap;Park, Chan-Woo;Yang, Kwang-Moon;Lee, In-Ho;Kim, Tae-Jin;Lim, Kyung-Taek;Lee, Ki-Heon;Kang, Inn-Soo
    • Clinical and Experimental Reproductive Medicine
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    • v.34 no.2
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    • pp.87-94
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    • 2007
  • Objective: To examine determinants of successful pregnancy and evaluate COH-IVF outcomes of infertile patients after conservative surgical treatment of borderline ovarian tumor (BOT). Methods: In women of BOT (n=93), from January 1995 to December 1999, 44 of 93 women underwent conservative surgical treatment. From theses 44 women, patients characteristics, surgical and histological parameters were compared between 14 women who conceived and 30 women who failed to conceive. For 5 infertile women of 30 women who failed to conceive, 10 attempt IVF cycles were analysed; clinical pregnancy rate (CPR), implantation rate (IR) and live birth rate (LBR). Results: Women who conceived tend to be younger (25.9 vs 27.0 years) and lower serum CA-125 level (59.7 vs 72.9) compared to women who failed to conceive without significant difference. For 8 cycles out of 10 attempt IVF cycles, except for 2 cancellation cycles, the mean number of oocytes retrieved was 5.6 (range 2$\sim$16) with a mean fertilization rate of 74.4%. The CPR, IR and LBR per embryo transfer were 50.0% (4/8 cycles), 31.6% (6/19) and 50.0% (4/8 cycles) respectively. During the mean follow-up period after COH-IVF initiation, 29.6 (range 14$\sim$61) months, no recurrence was found. Conclusion: No determinant of successful pregnancy was found after conservative treatment for BOT. COH-IVF may be considered for infertile patients after conservative treatment of BOT. However, larger clinical studies with longer follow-up are necessary to evaluate the safety and efficacy of COH-IVF. All patients should be informed of the potential risks associated with ovarian hyperstimulation and close follow-up is necessary after COH-IVF.