Clinical trial NCT02825849: Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair
Official title: Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair: a Prospective Randomised Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Infertility
Asherman's Syndrome
Keywords: endometrium
thin uterine lining
uterine scarring
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: During Study Period #1: Subjects were randomized to receive either PRP or standard care. A total of 13 subjects were randomized.

The study design was then altered to remove randomization (10/4/2018). All patients in Study Period #2 received PRP. An additional 14 subjects were enrolled in Study Period #2.
Primary purpose: TREATMENT

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.

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:
* 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.

Eligibility 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

Primary outcomes:
measure: Endometrial Thickness
timeFrame: 3-30 days after treatment
Secondary outcomes:
measure: Number of Participants With Ultrasound Confirmed Clinical Pregnancies
timeFrame: at least 7 weeks after treatment
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco - Center for Reproductive Health
state: California
Study officials:
affiliation: University of California, San Francisco
name: Heather G. Huddleston, MD
role: PRINCIPAL_INVESTIGATOR
References: