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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Infertility Asherman's Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Intrauterine infusion of platelet rich plasma

Intervention Type BIOLOGICAL

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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PRP

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes