Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair
Status: | Completed |
---|---|
Conditions: | Women's Studies, Infertility |
Therapuetic Areas: | Reproductive |
Healthy: | No |
Age Range: | 18 - 43 |
Updated: | 3/29/2019 |
Start Date: | November 2016 |
End Date: | March 2019 |
Platelet-rich Plasma (PRP) for Endometrial Regeneration and Repair: a Prospective Randomised Pilot Study
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.
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.
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.
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.
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
We found this trial at
1
site
San Francisco, California 94158
Phone: 415-353-7475
Click here to add this to my saved trials