Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Halim Fertility Center | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to learn if platelet rich plasma (PRP) works to improve embryo development rates and embryo quality in IVF cycles, involving male adult patients with severe sperm disorders.
The main questions it aims to answer are:
Researchers will compare embryos from IVF patients treated with PRP to those not treated with PRP to see if PRP improves embryo development and embryo quality.
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRP | Experimental |
| |
| Non-PRP | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma | Biological | Platelet-rich plasma (PRP) will be prepared from autologous blood collected from each participant. The blood sample will undergo centrifugation at 1400 rpm for 15 minutes to separate and concentrate the platelet-rich fraction. The resulting PRP will then be isolated and added to the participant's sperm sample for use in the IVF procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Blastocyst formation rate (%) | Blastocyst formation rate is defined as the proportion of fertilised oocytes that successfully develop into blastocysts by Day 5 of embryo culture. It is calculated as the number of embryos reaching the blastocyst stage on Day 5 divided by the total number of normally fertilised oocytes (2 pronuclei, 2PN), expressed as a percentage. Embryo development is assessed using standard morphological criteria under microscopy, and only embryos meeting established blastocyst-stage characteristics are included in the numerator. | From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Fertilisation rate (%) | Fertilisation rate refers to the percentage of mature eggs that are successfully fertilised after being combined with sperm in the laboratory. It is calculated by dividing the number of eggs that show normal signs of fertilisation by the total number of mature eggs used for insemination, then multiplying by 100. Normal fertilisation is identified by the presence of two distinct structures inside the egg when examined under a microscope approximately 16-18 hours after insemination. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Halim Fertility Center, RSIA Stella Maris lantai 5, Jl. Samanhudi No.20, J A T I, Kec. Medan Maimun, Kota Medan, Sumatera Utara 20152 | Medan | North Sumatra | 20152 | Indonesia |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| From enrollment to fertilisation of the embryo (day 1). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase. |
| Cleavage rate (%) | Cleavage rate refers to the percentage of fertilised eggs that undergo early cell division during the first 3 days of embryo development. It is calculated by dividing the number of fertilised eggs that successfully divide into two or more cells by the total number of normally fertilised eggs, then multiplying by 100. Embryos are observed under a microscope to confirm cell division and early development. | From enrollment to cleavage development (day 3). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase. |
| Good-quality blastocyst (%) | Good quality blastocyst refers to the proportion of embryos that develop into blastocysts by Day 5 and meet predefined criteria for high quality based on their appearance under a microscope. It is calculated by dividing the number of blastocysts classified as good quality by the total number of blastocysts formed, then multiplying by 100. Blastocyst quality is assessed using standard grading systems that evaluate the degree of expansion, the appearance of the inner cell mass and the outer cell layer. Only blastocysts meeting the predefined criteria for good quality are included. | From enrollment to blastocyst development (days 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase. |
| Fair-quality blastocyst (%) | Fair quality blastocyst refers to the proportion of embryos that develop into blastocysts by Day 5 and meet predefined criteria for intermediate (fair) quality based on their appearance under a microscope. It is calculated by dividing the number of blastocysts classified as fair quality by the total number of blastocysts formed, then multiplying by 100. Blastocyst quality is assessed using standard grading systems that evaluate how expanded the blastocyst is, the appearance of its inner cell mass and outer cell layer. Only blastocysts meeting the predefined criteria for fair quality are included. | From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase. |
| Poor-quality blastocyst (%) | Poor quality blastocyst refers to the proportion of embryos that develop into blastocysts by Day 5 but are classified as low quality based on their appearance under a microscope. It is calculated by dividing the number of blastocysts assessed as poor quality by the total number of blastocysts formed, then multiplying by 100. Blastocyst quality is evaluated using standard grading criteria that consider the degree of expansion, the appearance of the inner cell mass and the outer cell layer. Blastocysts that show limited expansion or irregular or poorly defined structures are classified as poor quality. | From enrollment to blastocyst development (day 5). Enrollment occurs approximately 8-14 days prior to oocyte pickup (day 0) during the ovarian stimulation phase. |
| Apr 28, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009845 | Oligospermia |
| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided