Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair (PRP-E)

• ClinicalTrials.gov Identifier: NCT02825849
• Recruitment Status: Completed
• First Posted: July 7, 2016
• Last Update Posted: March 27, 2019
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

Brief Summary:

Patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial lining in in vitro fertilization (IVF) treatment programs, particularly those resistant to standard therapies, present a significant clinical challenge. The aim of this trial is to assess if intrauterine administration of platelet rich plasma (PRP) improves endometrial lining thickness in patients with thin lining or Asherman's Syndrome.

Condition or disease	Intervention/treatment	Phase
Infertility; Asherman's Syndrome	Biological: Intrauterine infusion of platelet rich plasma	Phase 2

Detailed Description:

BACKGROUND:

There is a need for new and more effective therapies for patients with intrauterine adhesions (Asherman's Syndrome) and persistent thin endometrial lining in in vitro fertilization (IVF) treatment programs, particularly for patients resistant to standard therapies

HYPOTHESIS:

Platelet rich plasma stimulates cellular processes involved in endometrial regeneration relevant to management of a thin lining or intrauterine scarring.

PRIMARY AIMS:

- To measure the change in endometrial lining thickness

SECONDARY AIMS:

• To determine if fertility is improved in patients receiving platelet rich plasma (PRP):

  1. In patients with thin lining undergoing frozen embryo transfer (FET), to determine:

• the chance of having embryo transfer,
• implantation rate

• clinical pregnancy rate

  2. In patients with Asherman's Syndrome, to determine:

• the rate of return/normalization of menses
• the chance of spontaneous pregnancy
• the chance of embryo transfer

Any adverse effects of study arm will be monitored and reported as appropriate.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Modified to nonrandomized allocation due to lack of patients willing to be randomized following initial enrollment period. 20 enrolled patients compared to 20 case-controls matched for thin lining and Asherman's syndrome.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair: a Prospective Randomised Pilot Study
• Study Start Date: November 2016
• Actual Primary Completion Date: March 2019
• Actual Study Completion Date: March 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Biological: 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.; Other Name: PRP
No Intervention: Control group with standard treatment only; Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols

Outcome Measures

Primary Outcome Measures :

1. Endometrial thickness [ Time Frame: 3-30 days after treatment ]
   Endometrial thickness will be measured using transvaginal ultrasound per standard protocol

Secondary Outcome Measures :

1. Implantation rate (for patients with thin lining) [ Time Frame: approximately 7 weeks after treatment ]
   defined by number of gestational sacs seen on early pregnancy 6-week ultrasound divided by number of embryos transferred
2. Clinical pregnancy rate (for patients with thin lining) [ Time Frame: approximately 7 weeks after treatment ]
   Defined by the number of fetal poles with heartbeat seen on 6-week ultrasound divided by the number of embryos transferred
3. Return/normalization of menstrual flow (for patients with Asherman's Syndrome) [ Time Frame: 1-3 months after treatment ]
   Patients will be asked to record the menstrual flow diary (Menstrual Assessment Chart) before treatment and for 1-3 months after treatment

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 43 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Persistent thin lining < 6mm on >1 cycle in previous IVF or FET cycle OR moderate-to-severe Asherman's syndrome

Exclusion Criteria:

• Age <18 years old or >43 years old,
• Pregnancy,
• Diagnosis of cancer,
• Hb <11 g/dL, platelets <150,000/mm3,
• Anticoagulation,
• NSAIDs in the 10 days before procedure
• Any significant comorbidity or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
• Incision in the uterus: myomectomy; cesarean section

Contacts and Locations

Locations

United States, California

University of California San Francisco - Center for Reproductive Health

San Francisco, California, United States, 94158

Sponsors and Collaborators

University of California, San Francisco

Investigators

• Principal Investigator: Heather G. Huddleston, MD; University of California, San Francisco

More Information

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT02825849
• Other Study ID Numbers: 16-19764
• First Posted: July 7, 2016
• Last Update Posted: March 27, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by University of California, San Francisco:

endometrium; thin uterine lining; uterine scarring

Additional relevant MeSH terms:

Infertility; Gynatresia