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NCT Number: NCT06599671

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

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.

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Key information

Age range

19 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • It was diagnosed by MRI as a large niche (defined as niche with a depth of >50% of the myometrial thickness and a residual myometrial thickness (RMT) ≤3mm);
  • Infertility secondary to niche (the inability to conceive within 12 months of unprotected intercourse or repeated failed IVF);
  • Fertility requirements;
  • Signed informed consent.

Exclusion criteria

  • Age below 18 years or over 49 years;
  • Contraindications for intraspinal or general anaesthesia;
  • A (suspected) malignancy or combined benign lesions requiring hysterectomy;
  • Atypical endometrial cells or cervical dysplasia;
  • Uterine or cervical polyps;
  • Submucosal fibroids;
  • Hydrosalpinx.

Treatment and study plan

Transvaginal niche resection

Procedure

In short: the bladder was carefully dissected away from the uterus towards the abdominal cavity to open the vesicovaginal space and reach the peritoneum. The fingers on the anterior wall isthmus could touch the obvious scar-like defect. The weak scar tissue then thoroughly was removed.

Primary outcomes

  1. Live birth rate

    Time frame: Total follow-up will extend to 15 months after randomization.

    Live birth is defined as a live born neonate beyond 24 weeks of gestation.

Study contacts

Contact information is provided by the study sponsor or research team.

Qunying Cai

CONTACT

[email protected]

086 13621906294

Sponsors and collaborators

Lead sponsor

International Peace Maternity and Child Health Hospital

Other

Registry information

Official study title

Effectiveness of Transvaginal Niche Resection Versus Expectant Management in Patients with Secondary Infertility and a Large Uterine Caesarean Scar Defect (niche), a Randomised Controlled Trial

Acronym: TVARES

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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