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The objective of this study is to perform a prospective randomized controlled trial seeking to characterize the effects of intra-ovarian injection of platelet rich plasma (PRP) on biomarkers of ovarian reserve as well as IVF outcomes in women with primary ovarian insufficiency (POI) and poor ovarian response (POR) who decline the use of an egg donor to establish a pregnancy.
Patients will be randomized to either receive the intra-ovarian PRP injection procedure or not. Regardless of randomization patients will be re-assessed at the same time points for ovarian reserve parameters. If antral follicles are detected at follow up, patients will undergo controlled ovarian hyperstimulation and a routine in vitro fertilization cycle as per protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Patients randomized to this group will receive the intra-ovarian platelet rich plasma injection |
|
| Control Group | No Intervention | Patients randomized to this group will not receive the intra-ovarian platelet rich plasma injection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intra-ovarian platelet rich plasma injection | Other | patients will undergo a transvaginal intra-ovarian platelet rich plasma injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| number of participants with a mature oocyte retrieved- POI group | success or failure is determined by the retrieval of at least one mature oocyte | 24 hours post egg retrieval procedure |
| number of mature oocytes retrieved- POR group | the total number of mature oocytes retrieved | 24 hours post egg retrieval procedure |
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Inclusion criteria
POI according to ESHRE criteria (patient must fit both criteria):
POR defined by at least two prior cycles with POR (≤3 oocytes retrieved with a conventional stimulation protocol, or a cancelled cycle due to poor response)
Patients declining ovum donation treatment
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Emre U Seli, MD | Reproductive Medicine Associates of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medicine Associates of New Jersey | Basking Ridge | New Jersey | 07920 | United States | ||
| Acibadem University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38725194 | Derived | Herlihy NS, Cakiroglu Y, Whitehead C, Reig A, Tiras B, Scott RT Jr, Seli E. Effect of intraovarian platelet-rich plasma injection on IVF outcomes in women with poor ovarian response: the PROVA randomized controlled trial. Hum Reprod. 2024 May 9:deae093. doi: 10.1093/humrep/deae093. Online ahead of print. |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Istanbul |
| Turkey (Türkiye) |
| D000091662 | Genital Diseases |
| D007246 | Infertility |