RESUMO
BACKGROUND: In in vitro fertilization (IVF) and intracytoplasmatic sperm injection (ICSI) treatment a large drop is present between embryo transfer and occurrence of pregnancy. The implantation rate per embryo transferred is only 30%. Studies have shown that minor intrauterine abnormalities can be found in 11-45% of infertile women with a normal transvaginal sonography or hysterosalpingography. Two randomised controlled trials have indicated that detection and treatment of these abnormalities by office hysteroscopy after two failed IVF cycles leads to a 9-13% increase in pregnancy rate. Therefore, screening of all infertile women for intracavitary pathology prior to the start of IVF/ICSI is increasingly advocated. In absence of a scientific basis for such a policy, this study will assess the effects and costs of screening for and treatment of unsuspected intrauterine abnormalities by routine office hysteroscopy, with or without saline infusion sonography (SIS), prior to a first IVF/ICSI cycle. METHODS/DESIGN: Multicenter randomised controlled trial in asymptomatic subfertile women, indicated for a first IVF/ICSI treatment cycle, with normal findings at transvaginal sonography. Women with recurrent miscarriages, prior hysteroscopy treatment and intermenstrual blood loss will not be included. Participants will be randomised for a routine fertility work-up with additional (SIS and) hysteroscopy with on-the-spot-treatment of predefined intrauterine abnormalities versus the regular fertility work-up without additional diagnostic tests. The primary study outcome is the cumulative ongoing pregnancy rate resulting in live birth achieved within 18 months of IVF/ICSI treatment after randomisation. Secondary study outcome parameters are the cumulative implantation rate; cumulative miscarriage rate; patient preference and patient tolerance of a SIS and hysteroscopy procedure. All data will be analysed according to the intention-to-treat principle, using univariate and multivariate logistic regression and cox regression. Cost-effectiveness analysis will be performed to evaluate the costs of the additional tests as routine procedure. In total 700 patients will be included in this study. DISCUSSION: The results of this study will help to clarify the significance of hysteroscopy prior to IVF treatment. TRIAL REGISTRATION: NCT01242852.
Assuntos
Fertilização in vitro , Histeroscopia , Infertilidade Feminina/terapia , Doenças Uterinas/diagnóstico , Útero/anormalidades , Protocolos Clínicos , Análise Custo-Benefício , Feminino , Humanos , Histeroscopia/economia , Infertilidade Feminina/diagnóstico por imagem , Infertilidade Feminina/economia , Infertilidade Feminina/etiologia , Análise de Intenção de Tratamento , Modelos Logísticos , Análise Multivariada , Países Baixos , Preferência do Paciente , Gravidez , Taxa de Gravidez , Modelos de Riscos Proporcionais , Método Simples-Cego , Injeções de Esperma Intracitoplásmicas , Resultado do Tratamento , Ultrassonografia , Doenças Uterinas/complicações , Doenças Uterinas/diagnóstico por imagem , Doenças Uterinas/economia , Útero/diagnóstico por imagemRESUMO
Transanal endoscopic microsurgery has been used by surgeons since 1983. All these years of experience and research have shown that this is a safe and successful approach for rectal neoplasms, both benign and malignant. The advantage of this procedure is the excellent view and hence precise surgical margins in an operative field that is otherwise difficult to reach. Furthermore, selected patients who used to require major rectal surgery now may be treated using this minimally invasive technique. These advantages may also be favorable for the gynecological field, especially in intravaginal surgery. Our case report describes the first successfully performed transvaginal endoscopic microsurgery in a woman with residual disease after treatment with chemoradiation for squamous cell carcinoma of the vagina. Despite the difficulty of operating in tissue with post-radiation effect, the rest of the tumor was excised with clear surgical margins without damage to the rectum. The patient was discharged from the hospital 2 days after the procedure and recovered without complications.