NCT07176143

hBMSC Uterine Artery Infusion for Severe IUA-Related Infertility

Not yet recruiting NA Last updated 16 September 2025

What this trial tests

NA trial testing Delivering human bone marrow mesenchymal stem cells via the uterine artery in Intrauterine Adhesions in 60 participants. Not yet recruiting.

Timeline

30 September 2025

Primary endpoint
30 December 2027

30 December 2028

Quick facts

Lead sponsor	Sixth Affiliated Hospital, Sun Yat-sen University
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	30 September 2025
Primary completion	30 December 2027
Estimated completion	30 December 2028

Drugs / interventions tested

• Delivering human bone marrow mesenchymal stem cells via the uterine artery

Conditions studied

• Intrauterine Adhesions — all drugs for Intrauterine Adhesions →

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Who can join

Adults 20 to 38, female only, with Intrauterine Adhesions. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to test a new approach: delivering human bone marrow mesenchymal stem cells (hBMSCs) via the uterine artery to treat infertility caused by severe intrauterine adhesions (IUA). This method may help stem cells better reach the deep layer of the endometrium, promote endometrial repair, and improve pregnancy chances.

Primary Objective: To assess whether stem cell therapy improves pregnancy success rates (clinical pregnancy rate after embryo transfer) in infertility patients with severe IUA undergoing IVF.

Secondary Objectives:

1. To evaluate the safety of stem cell therapy (e.g., side effects or complications).
2. To explore how stem cells help repair the endometrium (e.g., by promoting endometrial growth or improving uterine conditions).

By tracking endometrial thickness, embryo implantation rate, clinical pregnancy rate, and other indicators, we will evaluate whether this new approach is safe and effective.

Treatment Groups:

Control group: Standard hormone replacement therapy (HRT) cycle medication only.

Stem cell therapy group: Standard HRT medication + hBMSC infusion via uterine artery.

Both groups will undergo embryo transfer, and clinical pregnancy rates will be compared.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Stem cell therapy-based approaches in experimental endometriosis: a systematic review.
   Suárez-Carrasco I, De Pedro MÁ, Pulido M, Álvarez V, et al · · 2026 · PMID 41998676 · DOI 10.1186/s12958-026-01553-w