The Aim of This Study is to Gain Insight Into the Occurrence of Irritable Bowel Symptoms During Ovarian Stimulation in Individuals With PCOS and in Women Who Wish to Freeze Their Eggs. This Study Uses Questionnaires.

NCT07533968 | Not Yet Recruiting

• 1 other identifier: 1432025000254
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

PCOS (Polycystic Ovary Syndrome)

Outcome Measures

Primary Outcomes (2)

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

  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.

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

• Change in IBS symptom severity before and after ovarian stimulation

  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.

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

Secondary Outcomes (3)

• 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

Other Outcomes (1)

• Association between clinical and demographic factors and IBS symptom severity

  From start of ovarian stimulation to oocyte retrieval, up to 14 days

Study Arms (2)

PCOS group

EXPERIMENTAL

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

Other: questionnaires

Social freezing group

EXPERIMENTAL

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

Other: questionnaires

Interventions

questionnaires OTHER

Questionnaires: Rome III and IV criteria, GSRS, IBS-SSS, PHQ-9 and GAD-7

PCOS group; Social freezing group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04