Asherman's Syndrome, Infertility
Conditions
Keywords
endometrium, thin uterine lining, uterine scarring
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.
Interventions
BIOLOGICALIntrauterine 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.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endometrial Thickness | 3-30 days after treatment | Endometrial thickness will be measured using transvaginal ultrasound per standard protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
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. | 22 |
| Control Group With Standard Treatment Only Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols | 5 |
| Total | 27 |
Baseline characteristics
| Characteristic | PRP Intrauterine Infusion | Control Group With Standard Treatment Only | Total |
|---|---|---|---|
| Age, Continuous | 37.9 years STANDARD_DEVIATION 3.2 | 35.6 years STANDARD_DEVIATION 6.3 | 37.5 years STANDARD_DEVIATION 3.9 |
| Ashermans score on hysteroscopy | 5.6 score STANDARD_DEVIATION 1.17 | 5.8 score STANDARD_DEVIATION 2.49 | 5.67 score STANDARD_DEVIATION 1.63 |
| Endometrial Thickness | 6.3 cm STANDARD_DEVIATION 2.3 | 4.3 cm STANDARD_DEVIATION 1.2 | 5.9 cm STANDARD_DEVIATION 2.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 22 Participants | 5 Participants | 27 Participants |
| Sex: Female, Male Female | 22 Participants | 5 Participants | 27 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 5 |
| other Total, other adverse events | 0 / 22 | 0 / 5 |
| serious Total, serious adverse events | 0 / 22 | 0 / 5 |
Outcome results
Primary
Endometrial Thickness
Endometrial thickness will be measured using transvaginal ultrasound per standard protocol
Time frame: 3-30 days after treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PRP Intrauterine Infusion | Endometrial Thickness | 6.4 cm | Standard Deviation 2.4 |
| Control Group With Standard Treatment Only | Endometrial Thickness | 5.2 cm | Standard Deviation 2.3 |
Secondary
Number of Participants With Ultrasound Confirmed Clinical Pregnancies
Defined by ultrasound confirmed pregnancies per total participants in each arm
Time frame: at least 7 weeks after treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRP Intrauterine Infusion | Number of Participants With Ultrasound Confirmed Clinical Pregnancies | 12 Participants |
| Control Group With Standard Treatment Only | Number of Participants With Ultrasound Confirmed Clinical Pregnancies | 3 Participants |
p-value: 0.824Chi-squared