Trial Outcomes & Findings for Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair (NCT NCT02825849)

NCT ID: NCT02825849

Last Updated: 2021-02-09

Results Overview

Endometrial thickness will be measured using transvaginal ultrasound per standard protocol

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: 3-30 days after treatment
• Results posted on: 2021-02-09

Participant Flow

Participant milestones

Measure	PRP Intrauterine Infusion Intrauterine infusion of platelet rich plasma in combination with standard treatment, in patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles Intrauterine infusion of platelet rich plasma: Patients randomized to study group will have 30cc of blood drawn with isolation of platelet rich plasma (PRP) per standard manufacturer's protocol, with subsequent intrauterine infusion of this autologous PRP.	Control Group With Standard Treatment Only Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols
Overall Study STARTED	22	5
Overall Study COMPLETED	22	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	PRP Intrauterine Infusion n=22 Participants Intrauterine infusion of platelet rich plasma in combination with standard treatment, in patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles Intrauterine infusion of platelet rich plasma: Patients randomized to study group will have 30cc of blood drawn with isolation of platelet rich plasma (PRP) per standard manufacturer's protocol, with subsequent intrauterine infusion of this autologous PRP.	Control Group With Standard Treatment Only n=5 Participants Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols	Total n=27 Participants Total of all reporting groups
Age, Continuous	37.9 years STANDARD_DEVIATION 3.2 • n=22 Participants	35.6 years STANDARD_DEVIATION 6.3 • n=5 Participants	37.5 years STANDARD_DEVIATION 3.9 • n=27 Participants
Sex: Female, Male Female	22 Participants n=22 Participants	5 Participants n=5 Participants	27 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=22 Participants	0 Participants n=5 Participants	0 Participants n=27 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	22 Participants n=22 Participants	5 Participants n=5 Participants	27 Participants n=27 Participants
Endometrial Thickness	6.3 cm STANDARD_DEVIATION 2.3 • n=22 Participants	4.3 cm STANDARD_DEVIATION 1.2 • n=5 Participants	5.9 cm STANDARD_DEVIATION 2.3 • n=27 Participants
Ashermans score on hysteroscopy	5.6 score STANDARD_DEVIATION 1.17 • n=8 Participants • This score was only calculated for patients with ashermans syndrome who had hysteroscopy in the randomized trial portion of the study.	5.8 score STANDARD_DEVIATION 2.49 • n=5 Participants • This score was only calculated for patients with ashermans syndrome who had hysteroscopy in the randomized trial portion of the study.	5.67 score STANDARD_DEVIATION 1.63 • n=13 Participants • This score was only calculated for patients with ashermans syndrome who had hysteroscopy in the randomized trial portion of the study.

PRIMARY outcome

Timeframe: 3-30 days after treatment

Endometrial thickness will be measured using transvaginal ultrasound per standard protocol

Outcome measures

Measure	PRP Intrauterine Infusion n=22 Participants Intrauterine infusion of platelet rich plasma in combination with standard treatment, in patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles Intrauterine infusion of platelet rich plasma: Patients randomized to study group will have 30cc of blood drawn with isolation of platelet rich plasma (PRP) per standard manufacturer's protocol, with subsequent intrauterine infusion of this autologous PRP.	Control Group With Standard Treatment Only n=5 Participants Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols
Endometrial Thickness	6.4 cm Standard Deviation 2.4	5.2 cm Standard Deviation 2.3

SECONDARY outcome

Timeframe: at least 7 weeks after treatment

Defined by ultrasound confirmed pregnancies per total participants in each arm

Outcome measures

Measure	PRP Intrauterine Infusion n=22 Participants Intrauterine infusion of platelet rich plasma in combination with standard treatment, in patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles Intrauterine infusion of platelet rich plasma: Patients randomized to study group will have 30cc of blood drawn with isolation of platelet rich plasma (PRP) per standard manufacturer's protocol, with subsequent intrauterine infusion of this autologous PRP.	Control Group With Standard Treatment Only n=5 Participants Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols
Number of Participants With Ultrasound Confirmed Clinical Pregnancies	12 Participants	3 Participants

Adverse Events

PRP Intrauterine Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group With Standard Treatment Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heather Huddleston

UCSF

Phone: 415-353-3040

Email: heather.huddleston@ucsf.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place