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Study Investigates IBS During Fertility Treatments

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Summary

The NIH ClinicalTrials.gov registry has posted a new observational study (NCT07533968) investigating the impact of fertility treatments on irritable bowel syndrome (IBS) symptoms in women. The study focuses on two cohorts: women with polycystic ovary syndrome (PCOS) beginning their first IVF cycle and women undergoing social egg freezing. Researchers will use questionnaires to track changes in IBS prevalence, severity, and associated anxiety and depression scores across multiple subgroups.

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What changed

A new clinical trial registration has been posted to ClinicalTrials.gov under NCT07533968. The study is an exploratory investigation that will use questionnaires to examine IBS symptoms during ovarian stimulation in women with PCOS and women pursuing elective egg freezing. The primary endpoint is change in IBS prevalence and severity; secondary analyses will evaluate relationships with anxiety, depression, and gastrointestinal complaints across subgroups defined by stimulation type, PCOS phenotype, ethnicity, and hormonal response.

Healthcare providers and clinical investigators conducting fertility treatments should be aware of this research, as findings may inform future guidance on managing gastrointestinal symptoms in patients undergoing ovarian stimulation. The study's focus on the gut-brain axis and psychological comorbidities adds to the growing body of evidence on holistic care during fertility treatments.

Archived snapshot

Apr 16, 2026

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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.

N/A NCT07533968 Kind: NA Apr 16, 2026

Abstract

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 T...

Conditions: PCOS (Polycystic Ovary Syndrome)

Interventions: questionnaires

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Last updated

Classification

Agency
NIH
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07533968

Who this affects

Applies to
Clinical investigators Healthcare providers
Industry sector
6211 Healthcare Providers
Activity scope
Clinical trial research Women's health services Medical questionnaires
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Public Health Pharmaceuticals

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