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

University of California San Francisco (UCSF)

Status and phase: Terminated; Phase 2

Conditions: Infertility; Asherman's Syndrome

Treatments: Biological: Intrauterine infusion of platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT02825849

16-19764

Details and patient eligibility

About

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.

Full 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:

• clinical pregnancy rate

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

• the chance of spontaneous pregnancy

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

Enrollment: 27 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

27 participants in 2 patient groups

PRP intrauterine infusion

Experimental group

Description:

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

Treatment:

Biological: Intrauterine infusion of platelet rich plasma

Control group with standard treatment only

No Intervention group

Description:

Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols