Thin Endometrium Clinical Trial
Official title:
Intrauterine Infusion of Autologous Platelet-Rich Plasma (PRP) in Women With Thin Endometrium Undergoing Embryo-transfer.
The goal of this interventional study is to evaluate the increasing in endometrial thickening after the intrauterine infusion of 0,5-1 ml of autologous Platelet-Rich Plasma (PRP) and the implantation rate in women with thin endometrium undergoing Embryo-transfer, in order to propose a novel therapeutic approach for women with an endometrium < 7 mm unresponsive to standard treatments.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | February 27, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 46 Years |
Eligibility |
Inclusion Criteria: - Endometrial thickness < 7 mm under estrogen replacement therapy or repeated implantation failure - Age between 18 and 46 years Exclusion Criteria: - Age < 18 and > 46 years - Pregnancy - Bleeding diathesis - Previous uterine surgery (miomectomy, cesarean section, etc...) - Platelet count < 105/µL - Hemoglobin < 10 g/dL - Presence of a tumor in the wound bed or metastatic disease - Current diagnosis of cancer - Other concomitant active infections |
Country | Name | City | State |
---|---|---|---|
Italy | Pugliese Ciaccio Hospital | Catanzaro |
Lead Sponsor | Collaborator |
---|---|
University Magna Graecia |
Italy,
Chang Y, Li J, Chen Y, Wei L, Yang X, Shi Y, Liang X. Autologous platelet-rich plasma promotes endometrial growth and improves pregnancy outcome during in vitro fertilization. Int J Clin Exp Med. 2015 Jan 15;8(1):1286-90. eCollection 2015. — View Citation
L. Aghajanova, S. Houshdaran, S. Balayan, J. Irwin, H. Huddleston, L. Giudice. Platelets for endometrial regeneration: a novel approach. Fertil Steril. Volume 106, Issue 3, Supplement, Page e82
Nazari L, Salehpour S, Hoseini S, Zadehmodarres S, Ajori L. Effects of autologous platelet-rich plasma on implantation and pregnancy in repeated implantation failure: A pilot study. Int J Reprod Biomed (Yazd). 2016 Oct;14(10):625-628. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Clinical pregnancy rate | Defined by the number of fetal poles with heartbeat seen on 6-week ultrasound divided by the number of embryos transferred | Approximately 8 weeks after treatment | |
Other | Return to spontaneous period | Records of a menstrual flow diary (Menstrual Assessment Chart) for 1-3 months after treatment | Approximately 1 to 3 months after treatment | |
Primary | Endometrial thickness | Endometrial thickness > 7 mm measured by means of transvaginal ultrasound | 24-48h after the intrauterine PRP infusion | |
Secondary | Positive pregnancy test rate | Positive pregnancy test rate after Embryo-transfer | Approximately 3 weeks after treatment | |
Secondary | Implantation rate | defined by number of gestational sacs seen on early pregnancy 6-week ultrasound divided by number of embryos transferred | Approximately 6 weeks after treatment |
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