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NCT03545945
Hysteroscopy in Chronic Anovulation
NA trial testing Additional office hysteroscopy in Chronic Anovulation. Withdrawn.
31 December 2020
Quick facts
| Lead sponsor | University of South Florida |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 September 2018 |
| Primary completion | 31 December 2020 |
| Estimated completion | 1 March 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Additional office hysteroscopy
- Endometrial biopsy
Conditions studied
- Chronic Anovulation — all drugs for Chronic Anovulation →
Sponsor
University of South Florida
Who can join
Adults 18 to 45, female only, with Chronic Anovulation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Patients with chronic anovulation presenting to the IVF clinic for subfertility treatment are at increased risk of endometrial hyperplasia and carcinoma.They are often subjected to endometrial biopsy to rule out any underlying changes such as endometrial hyperplasia or carcinoma before commencing any further treatment. Literature shows that these group of patients have higher possibility of having underlying uterine abnormality (uterine polyp, fibroid, septum, or adhesion) and if we perform only endometrial biopsy, these structural abnormalities will remain undetected. And presence of uterine abnormalities lead to difficulty in implantation, which eventually leads to lower success rate of infertility treatment. WE propose that performing simultaneous office hysteroscopy followed by endometrial biopsy in such patients will lead to higher detection of uterine structural abnormalities and obtaining endometrial tissue to rule out hyperplasia or carcinoma. The concern for clinicians at times is that performing both the procedures together will lead to higher pain perception during the procedure. But with the introduction of flexible hysteroscope which has a diameter of 3.5 mm we hypothesize that the pain of performing office hysteroscopy with endometrial biopsy and performing endometrial biopsy alone will be equivalent. Meanwhile, hysteroscopy will lead lead to detection of underlying uterine pathology and help us in taking directed biopsies.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03545945
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03545945 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of South Florida
- Last refreshed: 18 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03545945.
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