Rigid hymenal ring: a surgical option for insertional dyspareunia
Official title: Rigid Hymenal Ring as a Cause for Insertional Dyspareunia and Response to Surgical Treatment: a Prospective Longitudinal Cohort Study
Run by Hadassah Medical Organization · NCT07913386 · Data updated 2026-11-12
This study tests whether surgically removing a rigid hymenal ring helps reduce pain during penetration for women with insertional dyspareunia.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Hadassah Medical Organization Academic / other |
| Locations | 1 site (Jerusalem) |
| Status | Recruiting |
| Started | June 21, 2024 |
| Main results expected | December 2028 |
| Study ends | December 2028 |
| Registry record updated | November 3, 2026 |
| Trial ID | NCT07913386 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are premenopausal women aged 18–45 with insertional dyspareunia and a clinically rigid hymen causing provoked pain.
✕Probably not a fit
Patients whose pain has other causes or who do not have a clinically rigid hymen may not experience benefit from this procedure.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational cohort study will describe characteristics of women with insertional dyspareunia linked to a rigid hymenal ring and prospectively assess pain response after hymenectomy. Participants are premenopausal women aged 18–45 with self-reported sexual pain and a rigid hymen confirmed on examination. The primary intervention is hymenectomy, and outcomes will focus on changes in pain with penetration over time. The study aims to clarify whether this anatomic feature is a treatable cause of vestibuledynia–related pain and how patients fare after surgery.
Why it matters
Potential benefit: If successful, participants may experience reduced pain during intercourse after hymenectomy.
How similar studies have gone: Previous clinical observations suggest relief of vestibular pain after targeted hymenal surgery, but systematic prospective data are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18-45 2. Pre-menopausal 3. Patient experience insertional dyspareunia 4. Self-reported sexual pain intensity ≥3 in the 0-10 Visual Analogue Scale (VAS) or complete avoidance of penetrative intercourse due to pain severity 5. On exam, presence of rigid hymen, with pain provoked by its lateral stretching. The pain should be clinically relevant, i.e., the patient identifies this provoked pain as pain familiar to her from intercourse or penetration attempts. 6. ASA I or II 7. BMI\<35 Exclusion Criteria: Exclusion criteria 1. Previous vaginal delivery 2. Planned pregnancy in the upcoming year. 3. Previous hymenectomy, perineorrhaphy or vestibulectomy 4. Other identifiable causes for the pain, such as vulvovaginitis, dermatoses, scars etc. 5. Circumferential vestibular tenderness on Q-TIP examination 6. Major health conditions (cardiovascular, diabetes etc.) 7. Diagnosis of an unstable psychiatric disorder 8. Difficult airway and/or major lung disease 9. A need for intubation during surgery
Where it's running
-
Hadassah Medical Center
Jerusalem, Israel Recruiting
Study contacts
- Study coordinator: Ahinoam Lev-Sagie, Prof.
- Email: levsagie@netvision.net.il
- Phone: 972-54-3217178
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.