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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03629132
Other study ID # RPR-IUAs
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 15, 2018
Est. completion date December 30, 2019

Study information

Verified date August 2018
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Effect of platelet-rich plasma (PRP) on uterine scar fibrosis, endometrial receptivity and pregnancy outcome in patients with severe intrauterine adhesions


Description:

1. Inclusion criteria: patients with intrauterine adhesions (AFS score >9 points); age 21 to 40 years old, with fertility requirements.

2. Study design:prospective, randomized controlled cohort study, patients with intrauterine adhesions were randomized into two groups, the control group and the intervention group (intraoperative and postoperative 1 week postoperative PRP). The surgical procedures and postoperative medication regimens were the same.

3. Compare the biochemical pregnancy rate, clinical pregnancy rate, abortion rate and live birth rate after hysteroscopic resection in PRP group and control group, and explore the effect of PRP on pregnancy outcome after intrauterine adhesion.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 30, 2019
Est. primary completion date August 1, 2019
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 37 Years
Eligibility Inclusion Criteria:Patients with intrauterine adhesions (AFS score >9 points); age 21 to 40 years old, with fertility requirements -

Exclusion Criteria:Endometrial tuberculosis, endometrial polyps, uterine submucosal fibroids, endometrial hyperplasia, endometrial malignant lesions, premature ovarian failure, chromosomal abnormalities

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Platelet-rich plasma
Platelet-rich plasma intrauterine injection
gel
Self-crosslinking sodium hyaluronate gel intrauterine injection

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Yanhong Deng

Outcome

Type Measure Description Time frame Safety issue
Primary AFS score AFS score 1 year
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