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临床试验/NCT07533968
NCT07533968尚未招募不适用

Fertility Treatment: Impact on Symptoms of Irritable Bowel Syndrome

Universitair Ziekenhuis Brussel0 个研究点目标入组 120 人开始时间: 2026年4月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
120
主要终点
Proportion of participants meeting IBS diagnostic criteria before and after ovarian stimulation

研究概览

简要总结

This exploratory study investigates the impact of fertility treatments on symptoms of irritable bowel syndrome (IBS) in women. Specifically, the study focuses on two groups:

  • Women with polycystic ovary syndrome (PCOS) who are starting their first IVF cycle.
  • Women who choose social freezing (freezing eggs for social reasons).

Background and Rationale PCOS is an endocrine disorder with hormonal and metabolic abnormalities associated with reduced fertility. There are four PCOS phenotypes, of which phenotypes A and B are the "classic" forms. Social freezing is becoming increasingly popular as an option for women without a partner who want to preserve their fertility.

IBS is a common gastrointestinal disorder involving motility disorders and a disturbed gut-brain axis. There is an increased risk of anxiety and depression in IBS patients. Women with PCOS have a twofold increased risk of developing IBS. However, little is known about the effect of hormonal fertility treatments on IBS symptoms.

Objectives

  • Primary objective: To investigate whether fertility treatments influence the prevalence and severity of IBS symptoms.
  • Secondary objective: To investigate this change in IBS prevalence and severity in relation to:
  • Changes in anxiety and depression scores.
  • Changes in general gastrointestinal complaints.
  • Subgroup analyses based on:
  • Type of stimulation
  • Duration of desire to have children
  • Ethnicity
  • PCOS type
  • Hormonal and ultrasound response

Study design The study is a prospective, interventional exploratory study in which participants complete questionnaires before and after the hormonal stimulation phase.

  • Start date : March 1, 2026
  • End date of data collection: February 2027
  • Participation locations: Fertility Clinic UZ Brussels
  • Target sample size: 120 women (60 per group)

Data collected

Before treatment:

  • Demographics (height, weight, ethnicity)
  • Medical history related to fertility
  • PCOS phenotype (in study arm)

After treatment:

  • Hormonal values (FSH, LH, estrogen, progesterone)
  • Number of follicles on ultrasound
  • Number of eggs collected

Questionnaires:

  • IBS-SSS (IBS symptom severity)
  • Rome IV and III criteria (IBS diagnosis)
  • GSRS (general GI symptoms)
  • PHQ-9 (depression)
  • GAD-7 (anxiety)

Measuring instruments

  • Rome IV and III criteria: Diagnosis of IBS based on frequency and nature of abdominal pain and changes in bowel movements.
  • IBS-SSS: Five dimensions of IBS symptoms, score between 0 and 500.
  • GSRS: General gastrointestinal complaints in five domains.
  • PHQ-9 and GAD-7: Validation instruments for depression and anxiety.

Data management

  • Data is collected manually using paper questionnaires.
  • Data is then entered into RedCap.
  • Analysis is performed using SPSS.
  • Strict compliance with GDPR and confidentiality guidelines.

Statistical Analysis

  • Logistic regression: To determine the likelihood of meeting the Rome criteria before and after treatment.
  • Multiple linear regression: To identify factors that influence change in IBS-SSS scores.
  • Model selection: Based on AIC (Akaike Information Criterion).
  • Separate analyses for PCOS and social freezing groups.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosis of PCOS according to the 2004 Rotterdam criteria (only for the PCOS group and not for the social freezing group)
  • Initiating their first cycle of IVF treatment (PPOS and freeze only protocol)
  • Nulliparous
  • ≥ 18 years
  • Willing to participate in the study
  • Understanding Dutch, French or English

排除标准

  • - Known inflammatory bowel disorder
  • Known major intestinal bowel disorder
  • Known systemic or auto-immune disorder with implication for the GI system
  • History of abdominal surgery (appendectomy and cholecystectomy allowed if >6 months earlier)
  • History of gastro-enteritis in the past 6 weeks

研究组 & 干预措施

PCOS group

Experimental

Women with PCOS fill in questionnaires before ovarian stimulation and after.

干预措施: questionnaires (Other)

Social freezing group

Experimental

Women who want to freeze their eggs fill in the questionnaires before and after ovarian stimulation.

干预措施: questionnaires (Other)

结局指标

主要结局

Proportion of participants meeting IBS diagnostic criteria before and after ovarian stimulation

时间窗: "From start of ovarian stimulation to oocyte retrieval, up to 14 days"

Assessed using Rome III and Rome IV criteria. The number of participants meeting IBS diagnostic criteria will be compared before (at consultation) and after (at oocyte retrieval) ovarian stimulation.

Change in IBS symptom severity before and after ovarian stimulation

时间窗: From start of ovarian stimulation to oocyte retrieval, up to 14 days"

Assessed using the IBS Severity Scoring System (IBS-SSS), a validated 5-item questionnaire. Total scores range from 0 to 500, with categories: remission (\<75), mild (75-175), moderate (175-300), and severe (\>300). The total IBS-SSS score will be compared before (at consultation) and after (at oocyte retrieval) ovarian stimulation.

次要结局

  • Change in general gastrointestinal symptom severity before and after ovarian stimulation(From start of ovarian stimulation to oocyte retrieval, up to 14 days")
  • Change in depression levels before and after ovarian stimulation(From start of ovarian stimulation to oocyte retrieval, up to 14 days)
  • Change in anxiety levels before and after ovarian stimulation(From start of ovarian stimulation to oocyte retrieval, up to 14 days)

研究者

申办方类型
Other
责任方
Sponsor

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