PCOS (Polycystic Ovary Syndrome)FIBSNCT07533968
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.
A study testing questionnaires in people with PCOS (Polycystic Ovary Syndrome), run by Universitair Ziekenhuis Brussel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome)
- What is being tested?
- questionnaires
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- - 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
About this study
Official title: Fertility Treatment: Impact on Symptoms of Irritable Bowel Syndrome
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).
Read more
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)
- Being tested
- questionnaires
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
Questionnaires: Rome III and IV criteria, GSRS, IBS-SSS, PHQ-9 and GAD-7
| Study group | Role | What they receive |
|---|---|---|
| PCOS group | Experimental | Women with PCOS fill in questionnaires before ovarian stimulation and after. Receives: Other: questionnaires |
| Social freezing group | Experimental | Women who want to freeze their eggs fill in the questionnaires before and after ovarian stimulation. Receives: Other: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: "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.
Measured: 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
"Assessed using the Gastrointestinal Symptom Rating Scale (GSRS), a validated 15-item questionnaire scored on a 7-point Likert scale. The total GSRS score will be compared before (at consultation) and after (at oocyte retrieval) ovarian stimulation."
Measured: From start of ovarian stimulation to oocyte retrieval, up to 14 days"
Change in depression levels before and after ovarian stimulation
Assessed using the Patient Health Questionnaire (PHQ-9), a validated 9-item questionnaire. Total scores range from 0 to 27."
Measured: From start of ovarian stimulation to oocyte retrieval, up to 14 days
Change in anxiety levels before and after ovarian stimulation
Assessed using the Generalized Anxiety Disorder scale (GAD-7), a validated 7-item questionnaire. Total scores range from 0 to 21."
Measured: From start of ovarian stimulation to oocyte retrieval, up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome)Studies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07533968
- Sponsor's protocol ID
- 1432025000254
- Acronym
- FIBS
- Status last verified
- Apr 2026
- First submitted
- 6 Mar 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility Treatment: Impact on Symptoms of Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT07533968
- Acronym / sponsor ID
- FIBS / 1432025000254
- Conditions
- PCOS (Polycystic Ovary Syndrome)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS group | Experimental | Other: questionnairesWomen with PCOS fill in questionnaires before ovarian stimulation and after. |
| Social freezing group | Experimental | Other: questionnairesWomen who want to freeze their eggs fill in the questionnaires before and after ovarian stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesQuestionnaires: Rome III and IV criteria, GSRS, IBS-SSS, PHQ-9 and GAD-7 | Other | PCOS group, Social freezing group |
Primary outcome
Proportion of participants meeting IBS diagnostic criteria before and after ovarian stimulation
Time frame: "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
Time frame: 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.
3 secondary outcomes
Change in general gastrointestinal symptom severity before and after ovarian stimulation
Time frame: From start of ovarian stimulation to oocyte retrieval, up to 14 days"
Change in depression levels before and after ovarian stimulation
Time frame: From start of ovarian stimulation to oocyte retrieval, up to 14 days
Change in anxiety levels before and after ovarian stimulation
Time frame: From start of ovarian stimulation to oocyte retrieval, up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing questionnaires in people with PCOS (Polycystic Ovary Syndrome), run by Universitair Ziekenhuis Brussel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants meeting IBS diagnostic criteria before and after ovarian stimulation (time frame: "From start of ovarian stimulation to oocyte retrieval, up to 14 days"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.