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CompletedNCT04424160Updated Apr 20, 2021

Effects of Platelet Rich Plasma on Endometrium

An interventional study of PRP injection in the endometrium in Asherman Syndrome, sponsored by Acibadem University. Completed at 1 site in Turkey. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-04-20.

Sponsored by Acibadem University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
20 Years to 45 Years
Sex
Female
01

Study summary

Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal route after the cessation of menstrual period. The endometrial thickness will be assessed under ultrasound and hormone replacement will be started. As the endometrial thickness reaches adequate thickness during ultrasound follow-up, embryo transfer will be performed.

Read the detailed description

Intrauterine platelet rich plasma will be injected in the endometrial region via the vaginal route after the cessation of menstrual period. In the second menstrual period following the PRP injection, the endometrial thickness will be assessed under ultrasound and hormone replacement will be started. As the endometrial thickness reaches adequate thickness during ultrasound follow-up, embryo transfer will be performed. Pregnancy test results will be recorded and followed.

02

Conditions studied

  • Asherman Syndrome

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03

In context

Gynatresia

49 studies on the registry are indexed under Gynatresia; 17 are open to participants now.

This study's enrollment of 150 is above the median of 95 across 41 interventional studies indexed under Gynatresia.

Browse Gynatresia studies →

Lead sponsor

Acibadem University is the lead sponsor of 210 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women in whom cycle was cancelled due to an endometrial thickness \<7 mm when progesterone start was planned in patients undergoing frozen embryo transfer with hormone replacement therapy
  • Women with a history of Asherman syndrome, but no obvious intrauterine adhesion in the last hysteroscopic procedure;
  • Women who have at least 2 frozen good-quality embryos.

Exclusion criteria

Exclusion Criteria:

  • Women with any other known cause of implantation failure, such as poor embryo quality, or congenital uterine anomalies, endometrial polyp or fibroid,
  • Previous diagnosis of any malignancy,
  • Anticoagulant use for which plasma infusion is contraindicated,
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Endometrial PRP

    Patients in whom endometrial PRP was performed

    Biological: PRP injection in the endometrium

Interventions

  • BiologicalPRP injection in the endometrium

    Within 5 days after the cessation of menstrual period, endometrial PRP procedure will be planned. Approximately 20 ml of blood sample will be collected under sterile conditions, and PRP will be prepared. The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into the endometrial region of the endometrium in several positions.On the same day after the procedure, the patient will be observed in the outpatient room and will be discharged on the same day.

06

What researchers measure

Primary outcomes

  1. Endometrial thickness during hormone replacement therapy

    To measure endometrial thickness assessed by ultrasound during hormone replacement therapy for endometrial preparation in frozen-thawed cycles

    Time frame: 2-10 months

Secondary outcomes

  1. Pregnancy outcomes after frozen-thawed embryo transfer

    To assess pregnancy rates by beta-human chorionic gonadotropin and ultrasound after frozen-thawed embryo transfer cycles

    Time frame: 2-10 months

07

Study locations

1 site
  • Acıbadem Maslak Hospital IVF Unit
    Istanbul, 34460, Turkey
08

References and documents

Publications

  • 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. PubMed 25785127 ↗
  • Tandulwadkar SR, Naralkar MV, Surana AD, Selvakarthick M, Kharat AH. Autologous Intrauterine Platelet-Rich Plasma Instillation for Suboptimal Endometrium in Frozen Embryo Transfer Cycles: A Pilot Study. J Hum Reprod Sci. 2017 Jul-Sep;10(3):208-212. doi: 10.4103/jhrs.JHRS_28_17. PubMed 29142450 ↗
  • Zadehmodarres S, Salehpour S, Saharkhiz N, Nazari L. Treatment of thin endometrium with autologous platelet-rich plasma: a pilot study. JBRA Assist Reprod. 2017 Feb 1;21(1):54-56. doi: 10.5935/1518-0557.20170013. PubMed 28333034 ↗
  • Chang Y, Li J, Wei LN, Pang J, Chen J, Liang X. Autologous platelet-rich plasma infusion improves clinical pregnancy rate in frozen embryo transfer cycles for women with thin endometrium. Medicine (Baltimore). 2019 Jan;98(3):e14062. doi: 10.1097/MD.0000000000014062. PubMed 30653117 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04424160
Lead sponsor
Acibadem University
Collaborators
Baskent University
Responsible party
Bulent Tiras (Prof., Acibadem University) — Principal investigator
First posted
Jun 9, 2020
Start date
Sep 15, 2020
Primary completion
Apr 19, 2021
Completion
Apr 19, 2021
Last update
Apr 20, 2021

Study contacts

Hulusi Bulent Zeyneloglu, Prof
principal investigator · Baskent University Departments of Obstetrics and Gynecology
Yigit Cakiroglu, Assoc.Prof.
study director · Acibadem University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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