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Low recruitment and competing studies have published.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP intrauterine infusion | Experimental | 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 |
|
| Control group with standard treatment only | No Intervention | Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrauterine infusion of platelet rich plasma | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Endometrial Thickness | Endometrial thickness will be measured using transvaginal ultrasound per standard protocol | 3-30 days after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Ultrasound Confirmed Clinical Pregnancies | Defined by ultrasound confirmed pregnancies per total participants in each arm | at least 7 weeks after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather G. Huddleston, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco - Center for Reproductive Health | San Francisco | California | 94158 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Group With Standard Treatment Only | Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Endometrial Thickness | Endometrial thickness will be measured using transvaginal ultrasound per standard protocol | Posted | Mean | Standard Deviation | cm | 3-30 days after treatment |
|
Adverse events were collected for up to 365 days after study treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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The study was a pilot study and was not adequately powered to detect a difference. In addition the study was closed prior to full enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Huddleston | UCSF | 415-353-3040 | heather.huddleston@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2020 | Dec 2, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 25, 2019 | Dec 2, 2020 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 24, 2019 | Dec 2, 2020 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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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.
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|
| BG001 | Control Group With Standard Treatment Only | Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Endometrial Thickness | Mean | Standard Deviation | cm |
|
| Ashermans score on hysteroscopy | The American Fertility Society (presently ASRM) developed a classification system upon hysteroscopic assessment of intrauterine adhesions. Parameters assessed are: extent of cavity involved (<1/3, 1/3-2/3 an >2/3, with scores 1, 2, 4 respectively), type of adhesions (filmy, filmy and dense and dense, with scores 1, 2, 4 respectively), menstrual pattern (normal, hypomenorrhea, amenorrhea, with scores 0, 2, 4 respectively). Then overall severity of intrauterine adhesive disease is expressed as a total: stage 1 (mild) - score 1-4, Stage II (moderate (score 5-8), Stage III (severe)- score 9-12. | This score was only calculated for patients with ashermans syndrome who had hysteroscopy in the randomized trial portion of the study. | Mean | Standard Deviation | score |
|
Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols
|
|
| Secondary | Number of Participants With Ultrasound Confirmed Clinical Pregnancies | Defined by ultrasound confirmed pregnancies per total participants in each arm | Posted | Count of Participants | Participants | at least 7 weeks after treatment |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Control Group With Standard Treatment Only | Patients with Asherman's Syndrome or thin uterine lining in frozen embryo transfer cycles undergoing standard treatment protocols | 0 | 5 | 0 | 5 | 0 | 5 |
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| D005261 | Female Urogenital Diseases and Pregnancy Complications |