中文(简体)
Albanian
Arabic
Armenian
Azerbaijani
Belarusian
Bengali
Bosnian
Catalan
Czech
Danish
Deutsch
Dutch
English
Estonian
Finnish
Français
Greek
Haitian Creole
Hebrew
Hindi
Hungarian
Icelandic
Indonesian
Irish
Italian
Japanese
Korean
Latvian
Lithuanian
Macedonian
Mongolian
Norwegian
Persian
Polish
Portuguese
Romanian
Russian
Serbian
Slovak
Slovenian
Spanish
Swahili
Swedish
Turkish
Ukrainian
Vietnamese
Български
中文(简体)
中文(繁體)

Pozzi Forceps in Intrauterine Insemination

只有注册用户可以翻译文章
登陆注册
链接已保存到剪贴板
状态招聘中
赞助商
CHU de Quebec-Universite Laval

关键词

抽象

Many infertility and subfertility issues are treated nowadays with intrauterine inseminations. This is a minimally invasive technique that consists in placing sperm into a woman's uterus. Inseminations have only a fair success rate despite advances in technology ( 7 % per cycle). The goal of this study is to find an easy intervention that could help with success rate. Some studies are showing that the use of Pozzi tenaculum forceps might increase rates of pregnancy following intrauterine inseminations. In order to study the impact of this intervention, we are conducting a randomized controlled trial comparing the rate of term live births after IUI between patients who had their treatment done with a pozzi tenaculum forceps and those who had their treatment done without a tenaculum forceps.

描述

Once the initial investigations are done, an oral treatment is started on the first cycle if medically indicated.

At mid-cycle, patients undergo a transvaginal ultrasound looking for follicles' maturation. This ultrasound's goal is to detect ovulation and plan the IUI. If no follicle is detected, the transvaginal ultrasound is repeated later. If there is no luteinizing hormone (LH) peak detected upon ovulation urine test, there will be an ovulation induction with human chorionic gonadotropin (hCG) based depending on patient's age, number and size of detected follicles. Subcutaneous hCG or intramuscular hCG can be used. A cycle can be cancelled if there is no ovulation or if there is ovarian hyperstimulation.

During ovulation, semen analysis is performed, looking at sperm volume, sperm concentration and mobility. Then, semen is treated with a density gradient or with centrifugation. Isolated sperm are diluted in 0.5 to 1 mL of media and maintained in an incubator at a 37 º C temperature until insemination. The laboratory performs a second analysis on the washed semen in order to obtain the most accurate measures. If donor's semen is used, the andrology laboratory prepares the specimen and then processes with the semen analysis.

Patients are inseminated the day after a spontaneous LH peak or 24-36h after ovulation induction. For those who are randomized to the intervention group, a pozzi tenaculum forceps will be applied and clamped horizontally to the anterior cervical labrum with only a single click and mild traction will be applied in another to decrease the uterocervical angle. When no tenaculum is applied, motion will be mimicked without actual tissue prehension. Patients randomized to the control group will only have a tenaculum forceps applied in cases where the IUI is not feasible otherwise by the gynecologist. Indeed, it is sometimes necessary, when the cervical anatomy does not allow for easy pass of the catheter, for a pozzi tenaculum forceps to be used in order to insert the insemination catheter properly in the uterine cavity. In that case, tenaculum use will be recorded in the patient's file. No cervical insemination is allowed. Insemination is performed with flexible catheters and care is taken to avoid touching the uterine fundus with the catheter tip. There are multiple catheters available in the gynecology clinic, namely catheters The Curve (Cooper Surgical, Berlin), Shapeable IUI Catheter (Thomas Medical, Indianapolis) and Mini space (Laboratory C.C.D., Paris). After the intervention, patients are instructed to lie flat for 10 minutes after which they go home until next appointment.

Intercourse is allowed following IUI treatments. Patients are instructed to perform a urinary pregnancy test at home to weeks after the IUI, which will be provided to them. If the test is positive, patients are scheduled for a transvaginal ultrasound on week #7 of amenorrhea to confirm proper intrauterine pregnancy evolution. When pregnancy is confirmed, patients are referred to an physician for obstetrical follow-up.

In case of treatment failure, patients go on with ovulation induction or stimulation for the next cycle as previously prescribed by the gynecologist at mid-cycle ultrasound, if indicated. Dosages of ovarian stimulation medication may be modified, at physician's discretion, in order to optimize response to treatment according to the usual indications (ovarian hyperstimulation, side effects, poor response, etc.) Patients will be followed for 3 cycles and, if need be, can receive subsequent IUI treatments outside research protocol.

日期

最后验证: 12/31/2019
首次提交: 02/02/2018
提交的预估入学人数: 02/14/2018
首次发布: 02/18/2018
上次提交的更新: 01/22/2020
最近更新发布: 01/26/2020
实际学习开始日期: 05/31/2019
预计主要完成日期: 09/30/2020
预计完成日期: 12/31/2020

状况或疾病

Infertility
Insemination

干预/治疗

Procedure: Intrauterine insemination

-

手臂组

干预/治疗
Active Comparator: Pozzi for intrauterine insemination
Treatment done with a pozzi tenaculum forceps
Active Comparator: No Pozzi for intrauterine insemination
Treatment done without a tenaculum forceps

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别Female
接受健康志愿者
标准

Inclusion Criteria:

- Infertility :Defined as no pregnancy after one year of regular unprotected vaginal intercourse

- Infertility secondary to endometriosis, to a mild to moderate male factor, to an ovulatory dysfunction, an unexplained infertility or any other known medical indication for IUI.

- Intrauterine insemination with a partner's semen sample or a donor sample

- First IUI treatment or first treatment since last pregnancy

- Ovulation induction with letrozole medication

- Being able to speak and understand French

Exclusion Criteria:

- Bilateral tubal occlusion

- Active pelvic infection

- < 1 X 10^6 mobile sperm on semen analysis

结果

主要结果指标

1. Rate of live births [At the end of 1 cycle (approximately 28 days)]

Term delivery resulting from an intrauterine insemination cycle

次要成果指标

1. Clinical rate of pregnancy [At the end of 1 cycle (approximately 28 days)]

Positive urinary pregnancy test ou blood test (b-hcG)

2. Patients' global satisfaction [15 minutes after the intervention]

In regards of the treatment they received, yes/no questions Are you satisfied with the treatment you received? Do you think this treatment is an reasonable option of treatment?

3. Pain Level [15 minutes after the intervention]

Visual analog scale On a scale from 0-10 with intermediate values, 10 being the worst pain ever and 0 being no pain at all.

加入我们的脸书专页

科学支持的最完整的草药数据库

  • 支持55种语言
  • 科学支持的草药疗法
  • 通过图像识别草药
  • 交互式GPS地图-在位置标记草药(即将推出)
  • 阅读与您的搜索相关的科学出版物
  • 通过药效搜索药草
  • 组织您的兴趣并及时了解新闻研究,临床试验和专利

输入症状或疾病,并阅读可能有用的草药,输入草药并查看所使用的疾病和症状。
*所有信息均基于已发表的科学研究

Google Play badgeApp Store badge