Evaluation of the Potential Impact of HIV and Its Treatments on Ovarian Reserve: Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- change from inclusion visit AMH level at 18 months
研究概览
简要总结
Recent evidence suggests a decline in fertility of persons living with HIV (PLWH) (delayed pregnancies, sponteanous abortions, especially when patients receive an antiretroviral therapy, early menopause, amenorrhea and anovulatory cycles) with a possible decrease in ovarian reserve. However, indications of fertility preservation by freezing oocytes are nevertheless not clearly identified.
The objective of this study is to evaluate the ovarian reserve before and after the implementation of antiretroviral treatment in PLWH for whom the diagnosis of HIV has just been made.
详细描述
This is a monocentric prospective cohort study with minimal risk and constraints. Ovarian reserve is compared between two groups: 30 PLWH, at time of diagnosis and 6, 12 and 18 months after initiation of an antiretroviral therapy, and 30 HIV negative women attending medically assisted procreation consultation for male infertility, age, BMI and smoking habits matched.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
No masking
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For every participant :
- •woman aged 18 to 37
- •covered by social security
- •able to give an informed consent
- •Case group only :
- •diagnosis of HIV infection during the 3 months before inclusion
- •concomitant initiation of an antiretroviral therapy with integrase inhibitors and nucleoside analogues
- •Control group only :
- •assisting medically assisted procreation consultation for male infertility
- •matching case subjects with age, BMI and smoking habits
排除标准
- •For every participant :
- •current pregnancy
- •condition or associated treatment that may have an impact on fertility
- •premature ovarian failure
- •polycystic ovary syndrome
- •endometriosis
- •Control group only :
- •suspected HIV infection
研究组 & 干预措施
case
PLWH
干预措施: AMH test (Diagnostic Test)
case
PLWH
干预措施: pelvic ultrasound (Diagnostic Test)
control
HIV negative women, going to medically assisted procreation consultation for male infertility
干预措施: AMH test (Diagnostic Test)
control
HIV negative women, going to medically assisted procreation consultation for male infertility
干预措施: pelvic ultrasound (Diagnostic Test)
结局指标
主要结局
change from inclusion visit AMH level at 18 months
时间窗: M0 (inclusion visit) and M18 (after 18 months)
blood test to evaluate ovarian reserve thanks to AMH
次要结局
- estradiol, lutenizing hormone and follicle-stimulating hormone test(Month 0 (inclusion visit), Month 6 (after 6 months), Month 12 (after one year), Month18 (after 18 months))
- antral follicle count(Month 0 (inclusion visit), Month 6 (after 6 months), Month12 (after one year), Month18 (after 18 months))