Evaluation of Neuropeptide Expression During the Ovarian Cycle and in Patients With PCOS: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Evaluation of the normal fluctuation of SP during the ovarian cycle in non-PCOS women
研究概览
简要总结
The goal of this clinical trial is to characterize PCOS in terms of neuropeptide expression and to make the comparison between women with and without PCOS by going to analyze venous blood samples taken during the three phases of the ovarian cycle and follicular fluid, taken during the ovulatory phase as part of the oocyte pick-up. Specifically, the expression of neuropeptides such as CGRP, SP, VIP and enkephalins in the three phases of the ovarian cycle (follicular phase, ovulatory phase and luteal phase) will be evluated in three groups of women afferent to the medically assisted reproduction centre. In particular, Group 1 (control) will include women with regular ovarian cycle; Group 2 will include non-PCOS women undergoing ovarian stimulation and ICSI treatment; finally Group 3 will include women with PCOS undergoing ovarian stimulation and ICSI treatment.
The main question[s] it aims to answer are:
- Is there a fluctuation in blood neuropeptides concentrations of women with normal ovarian cycles during the three phases of the ovarian cycle?
- Do PCOS women has altered levels of blood and follicolar fluid concentration of neuropepides with respect to non-PCOS individuals?
- Is blood and follicolar fluid concentration of neuropeptide modulated by protocols of ovarian stimulation?
Participants of Group 1 will follow the ovarian monitoring protocol, during which blood samples will be taken at the three phases of the ovarian cycle.
Participants of Group 2 and 3 will undergo ovarian stimulation and ICSI treatment, followed by blood and follicular fluid sampling at the specified cycle phases.
Researchers will compare the control Group 1 with Group 2 and 3 to see if there is a significative difference in the concentration of blood neuropeptides between the three groups at the same phase of the ovarian cycle.
Moreover, they will evaluate if there is there significant different concentration of neuropeptides in follicolar fluid between group 2 and 3 during the ovulatory phase.
详细描述
This project aims to investigate the neurosensory mechanisms underlying one of the most common disorders related to folliculogenesis, such as PCOS. The study aims to characterize PCOS in terms of neuropeptide expression and to make the comparison between women with and without PCOS, by going to analyze venous blood samples taken during the three phases of the ovarian cycle and follicular fluid, taken during the ovulatory phase as part of the oocyte pick-up. Specifically, the expression of neuropeptides such as CGRP, SP, VIP and enkephalins in the three phases of the ovarian cycle (follicular phase, ovulatory phase and luteal phase) in the three groups of women considered will be evaluated.
Study design:
The study will enroll 45 total patients, referred to the PMA Center, divided into 3 groups of 15 patients each: Group 1 (control) women with regular ovarian cycle; Group 2- non-PCOS women undergoing ovarian stimulation and ICSI treatment; Group 3- women with PCOS undergoing ovarian stimulation and ICSI treatment.
The study will have a total duration of 24 months divided as follows:
- Pre-phase monitoring and enrollment of subjects (20 months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •infertile women
- •BMI between 18 and 30 kg/m2,
- •basal FSH < 10 IU/L,
- •number of antral follicles (2-10 m) per ovary > 10,
- •regular uterine cavity assessed by hysterosalpinography, sonohysterography or hysteroscopy, and hematologic and biochemical parameters within normal limits will be included in the study, euthyroid status (with or without treatment)
- •In case of women with PCOS, it should be diagnosed according to the Rotterdam criteria (The Rotterdam ESHRE/ASRM-sponsored PCOS consensus workshop group (2004) Revised 2003 consensus on diagnostic criteria and longterm health risks related to polycystic ovary syndrome (PCOS).
- •No restrictions regarding the indication of infertility.
排除标准
- •presence of ovaries inaccessible to oocyte pick-up,
- •presence of sactosalpinx, heterologous fertilization,
- •contraindication to pregnancy,
- •atypical genital discharge of unspecified cause,
- •uncontrolled dystothyroidism, presence of neoplasms,
- •severe alteration of liver or kidney function, taking medications that may interfere with the study.
结局指标
主要结局
Evaluation of the normal fluctuation of SP during the ovarian cycle in non-PCOS women
时间窗: 5 days postmenstrual, 14 days postmenstrual, 18 days postmenstrual
To evaluate the absolute difference of blood concentration of SP and the relative difference of its concentration \[100 - (CFO\*100/CFF) and 100 - (CFL\*100/CFO)\] in the three phases of the ovarian cycle: follicular phase (FF) (day 5-10 postmenstrual), ovulatory phase (FO) (day 14) and luteal phase (FL) (day 18-23) in women of childbearing age with regular ovarian cycle afferent to the PMA Center (Group 1).
Evaluation of the normal fluctuation of enkephalins during the ovarian cycle of non PCOS women
时间窗: 5 days postmenstrual, 14 days postmenstrual, 18 days postmenstrual
To evaluate the absolute difference of blood concentration of enkephalins and the relative difference of its concentration \[100 - (CFO\*100/CFF) and 100 - (CFL\*100/CFO)\] in the three phases of the ovarian cycle: follicular phase (FF) (day 5-10 postmenstrual), ovulatory phase (FO) (day 14) and luteal phase (FL) (day 18-23) in women of childbearing age with regular ovarian cycle afferent to the PMA Center (Group 1).
Evaluation of the normal fluctuation of CGRP during the ovarian cycle in non-PCOS women
时间窗: 5 days postmenstrual, 14 days postmenstrual, 18 days postmenstrual
To evaluate the absolute difference of blood concentration of CGRP and the relative difference of its concentration \[100 - (CFO\*100/CFF) and 100 - (CFL\*100/CFO)\] in the three phases of the ovarian cycle: follicular phase (FF) (day 5-10 postmenstrual), ovulatory phase (FO) (day 14) and luteal phase (FL) (day 18-23) in women of childbearing age with regular ovarian cycle afferent to the PMA Center (Group 1).
Evaluation of the normal fluctuation of VIP during the ovarian cycle in non-PCOS women
时间窗: 5 days postmenstrual, 14 days postmenstrual, 18 days postmenstrual
To evaluate the absolute difference of blood concentration of VIP and the relative difference of its concentration \[100 - (CFO\*100/CFF) and 100 - (CFL\*100/CFO)\] in the three phases of the ovarian cycle: follicular phase (FF) (day 5-10 postmenstrual), ovulatory phase (FO) (day 14) and luteal phase (FL) (day 18-23) in women of childbearing age with regular ovarian cycle afferent to the PMA Center (Group 1).
次要结局
- Evaluation of the fluctuation of CGRP during the ovarian cycle in non-PCOS women undergoing ICSI treatment(5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up)
- Evaluation of the fluctuation of enkephalins during the ovarian cycle in non-PCOS women undergoing ICSI treatment(5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up)
- Evaluation of the fluctuation of SP during the ovarian cycle in non-PCOS women undergoing ICSI treatment(5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up)
- Comparison of CGRP blood concentration between PCOS women and non-PCOS women undergoing ICSI treatment(5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up)
- Evaluation of the fluctuation of CGRP during the ovarian cycle in PCOS women undergoing ICSI treatment(5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up)
- Evaluation of the fluctuation of enkephalins during the ovarian cycle in PCOS women undergoing ICSI treatment(5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up)
- Evaluation of the fluctuation of VIP during the ovarian cycle in PCOS women undergoing ICSI treatment(5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up)
- Comparison of SP blood concentration between PCOS women and non-PCOS women undergoing ICSI treatment(5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up)
- Evaluation of the fluctuation of VIP during the ovarian cycle in non-PCOS women undergoing ICSI treatment(5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up)
- Evaluation of the fluctuation of SP during the ovarian cycle in PCOS women undergoing ICSI treatment(5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up)
- Comparison of VIP blood concentration between non-PCOS women with normal ovarian cycle and non-PCOS women undergoing ICSI treatment(7 days after menstruation, 14 days after menstruation, 20 days after menstruation)
- Comparison of enkephalins blood concentration between PCOS women and non-PCOS women undergoing ICSI treatment(5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up)
- Comparison of VIP blood concentration between PCOS women and non-PCOS women undergoing ICSI treatment(5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up)
- Comparison of SP blood concentration between non-PCOS women with normal ovarian cycle and non-PCOS women undergoing ICSI treatment(7 days after menstruation, 14 days after menstruation, 20 days after menstruation)
- Comparison of CGRP blood concentration between non-PCOS women with normal ovarian cycle and non-PCOS women undergoing ICSI treatment(7 days after menstruation, 14 days after menstruation, 20 days after menstruation)
- Comparison of enkephalins blood concentration between non-PCOS women with normal ovarian cycle and non-PCOS women undergoing ICSI treatment(7 days after menstruation, 14 days after menstruation, 20 days after menstruation)
- Comparison of CGRP concentration in follicolar fluid between non-PCOS women and PCOS women both undergoing ICSI treatment(5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up)
- Comparison of SP concentration in follicolar fluid between non-PCOS women and PCOS women both undergoing ICSI treatment(5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up)
- Comparison of VIP concentration in follicolar fluid between non-PCOS women and PCOS women both undergoing ICSI treatment(5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up)
- Comparison of enkephalins concentration in follicolar fluid between non-PCOS women and PCOS women both undergoing ICSI treatment(5 days before egg pick-up, day of egg pick up, 10 days after egg pick-up)
研究者
Sandro Gerli
Associate Professor of Obstetrics and Gynecology
University Of Perugia