Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction (LIFE)
A Retrospective and Prospective Study on the Impact of Infertility on the Sexual Sphere in Couples Undergoing Homologous and Heterologous Assisted Reproduction and in Fertile Controls
Fertile and infertile couples attending the Urology Unit and the Assisted Reproductive Technology (ART) Service at our Foundation will be enrolled. As part of the standard of care, all couples will undergo both a gynecological evaluation and consultation and an andrological evaluation and consultation.
In accordance with routine clinical practice, infertile couples will be asked during the consultation to complete validated self-administered questionnaires designed to assess the impact of infertility on their sexual function.
研究概览
详细说明
The aim of the study is to evaluate the impact of infertility on sexual function. The following validated questionnaires will be administered to both the study couples and the control group:
- All couples: Index of Sexual Satisfaction (ISS; 25 items; approximately 5 minutes to complete) and the Depression Anxiety Stress Scale-21 (DASS-21; 21 items; approximately 4 minutes to complete).
- Infertile couples only: Fertility Problem Inventory (FPI; 46 items; approximately 10 minutes to complete).
- All male participants: International Index of Erectile Function (IIEF; 15 items; approximately 4 minutes to complete).
- All female participants: Female Sexual Function Index (FSFI; 19 items; approximately 4 minutes to complete).
Questionnaire data will be collected from infertile couples undergoing homologous or heterologous assisted reproductive treatment. The control group will consist of couples attending the same outpatient clinic who have previously achieved at least one full-term pregnancy without the use of assisted reproductive technology (ART).
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Luca Boeri, MD, PhD
- 电话号码：+390255034501
- 邮箱：LUCA.BOERI@POLICLINICO.MI.IT
学习地点
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Mirano、意大利、20122
- 招聘中
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
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接触：
- Luca Boeri, MD, PhD
- 电话号码：+390255034501
- 邮箱：LUCA.BOERI@POLICLINICO.MI.IT
-
副研究员：
- Edgardo Somigliana, Prof., MD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Fertile and infertile couples attending the Urology Department and the MAR service
描述
Inclusion Criteria:
- Sexually active (at least 2 intercourses/week)
- Patients who have signed the informed consent form
Exclusion Criteria:
- Conditions that may affect the sexual function (induratio penis plastica, hypogonadism, genital lichen planus, dyspareunia)
- Psychiatric/depressive conditions
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：OTHER
队列和干预
团体/队列 |
|---|
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group 1
infertile men |
|
group 2 control
fertile men |
|
group 3
infertile women |
|
group 4 control
fertile women |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Men sexual health
大体时间：Day 1
|
Differences in the Sexual Satisfaction Index (ISS) score between infertile men undergoing homologous vs. heterologous fertilization. ISS have a Total Score Range from 0 to 100 (higher scores mean higher levels of sexual dissatisfaction). |
Day 1
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Women sexual health
大体时间：Day 1
|
Differences in the Sexual Satisfaction Index (ISS) score between infertile women undergoing homologous vs. heterologous fertilization. ISS have a Total Score Range from 0 to 100 (higher scores mean higher levels of sexual dissatisfaction). |
Day 1
|
|
Couples sexual health
大体时间：Day 1
|
Differences in the Sexual Satisfaction Index (ISS) score between subjects (both male and female) undergoing homologous or heterologous fertilization VS control of fertile couples. ISS have a Total Score Range from 0 to 100 (higher scores mean higher levels of sexual dissatisfaction). |
Day 1
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 7039
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