NCT06599671 (TVARES) is a NA clinical trial of Transvaginal niche resection in Caesarean Scar Defect, sponsored by International Peace Maternity and Child Health Hospital.

Who is sponsoring NCT06599671?

NCT06599671 is sponsored by International Peace Maternity and Child Health Hospital.

What drugs are being tested in NCT06599671?

Interventions in NCT06599671: Transvaginal niche resection.

What condition does NCT06599671 study?

NCT06599671 studies Caesarean Scar Defect.

Is NCT06599671 still recruiting?

NCT06599671 is currently not yet recruiting. Last updated 24 September 2024.

Last reviewed 2024-09-24 · How we verify

NCT06599671: TVARES

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effectiveness of Transvaginal Niche Resection Versus Expectant Management in Patients with Secondary Infertility and a Large Uterine Caesarean Scar Defect

Not yet recruiting NA Last updated 24 September 2024

What this trial tests

NA trial testing Transvaginal niche resection in Caesarean Scar Defect in 100 participants. Not yet recruiting.

Timeline

1 October 2024

Primary endpoint
30 September 2027

30 September 2027

Quick facts

Lead sponsor	International Peace Maternity and Child Health Hospital
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	1 October 2024
Primary completion	30 September 2027
Estimated completion	30 September 2027

Drugs / interventions tested

Transvaginal niche resection

Conditions studied

Caesarean Scar Defect — all drugs for Caesarean Scar Defect →

Sponsor

International Peace Maternity and Child Health Hospital

Who can join

Adults 19 to 48, female only, with Caesarean Scar Defect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to evaluate the efficacy and safety of transvaginal niche resection in improving pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility. The main questions it aims to answer are: 1. Does transvaginal niche resection improve pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility? 2. What medical problems do participants have when taking transvaginal niche resection? Researchers will compare transvaginal niche resection to expectant management (without any additional surgical intervention) to see if transvaginal niche resection works to improve pregnancy outcomes of a large uterine caesarean scar defect (niche) with secondary infertility. Participants will: 1. Undergo a procedure (transvaginal niche resection) within 2 week after randomization in the intervention group. Women were advised to use contraception in the first 6 months following niche resection to allow uterine healing prior to subsequent pregnancy. 2. Receive usual care at least 9 months which means no additional surgical intervention during this period in the control group. Patients are allowed to become pregnant and to receive fertility therapies if indicated. Any member of the control group who has not become pregnant after 9 months will be given the opportunity to undergo a transvaginal niche resection. 3. Receive a standardized magnetic resonance imaging (MRI) evaluation of the niches. Niches will be evaluated at baseline in all groups and at 3 months after surgery. 4. Be contacted by telephone at 6, 9 and 15 months to assess the primary and secondary outcomes.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other International Peace Maternity and Child Health Hospital trials

Trials by the same sponsor.

NCT07510139 — A Clinical Study of Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes for the Treatment of Premature Ovarian Insuffi · Phase 1, PHASE2 · active not recruiting
NCT06759480 — Study of Laparoscopic Radical Hysterectomy Based on Space Anatomy in Patients With IB3 and IIA2 Cervical Cancer · not yet recruiting
NCT07279181 — TVS, SHG, and MRI in Uterine Niche · completed
NCT06006091 — The Effectiveness of the Letrozole-induced Endometrial Preparation Protocol in Frozen-thawed Embryo Transfer (FET) · NA · recruiting
NCT06121388 — Brain MRI Imaging Changes and Associated Factors on Cognition Function in Patients With Premature Ovarian Failure · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06599671 (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 International Peace Maternity and Child Health Hospital
Last refreshed: 24 September 2024

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/NCT06599671.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing