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IMPACT

Investigating the Effects of Metabolic Bariatric Surgery on PCOS and Menstrual Cycle Trends - IMPACT

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58443
Enrollment
50
Registered
2025-05-20
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irregular menstruation, Polycycstic Ovary Syndrome Irregular menstruation, PCOS

Interventions

None listed

Sponsors

Frisius Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Women of reproductive age (18-39), scheduled to undergo Roux-en-Y gastric bypass or one anastomosis gastric bypass at the Center Obesity Northern Netherlands.

Exclusion criteria

Exclusion criteria: Post-menopausal women; Women who use a form of hormonal contraceptives; Women who plan to start using a form of hormonal contraceptives during the year following the gastric bypass;Women who use metformin or similar medications that effects insulin sensitivity;Women with gynecological procedures in their medical history that possibly affect their menstruation cycle (e.g. hysterectomy, oophorectomy, bilateral tubal ligation sterilization, ablation of endometrium); Women diagnosed with severe psychiatric or medical comorbidities known to possibly affect menstruation (e.g. depression, substance addictions, cancer (Nebgen et al., 2017; Padda et al., 2021; Shen et al., 2014)); Pregnant and post-natal women (until 6 months);Lack of proficiency in Dutch. 

Design outcomes

Primary

MeasureTime frame
The main study parameter is the differences in the prevalence of PCOS before, and one year after metabolic bariatric surgery. 

Secondary

MeasureTime frame
The prevalence of irregular menstruation before and one and three years after MBS;The effect of weight loss on the prevalence of menstruation irregularities and PCOS after surgery;The effect of BMI on the prevalence of menstruation irregularities and PCOS before surgery;The differences in 24-hour urinary steroid metabolite profile between women with irregular menstruation with and without PCOS;The effects of PCOS on quality of life.

Countries

Netherlands

Contacts

Public ContactM Hofman

Frisius Medisch Centrum

marije.hofman@frisiusmc.nl0653428813

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026