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

Phase 2

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
PRP intrauterine infusion	Intrauterine infusion of platelet rich plasma	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

Primary Outcome Measures

Name	Time	Method
Endometrial Thickness	3-30 days after treatment	Endometrial thickness will be measured using transvaginal ultrasound per standard protocol

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Ultrasound Confirmed Clinical Pregnancies	at least 7 weeks after treatment	Defined by ultrasound confirmed pregnancies per total participants in each arm