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A protocol was developed to improve pregnancy results after IVM compared to results from studies in the literature. Differences from most published protocols include the use of the Steiner-Tan needle to optimize oocyte environment during oocyte retrieval, use of oral medications and very low doses of FSH, and delayed embryo transfer during subsequent warmed cryo-preserved embryo transfer. Eligible patient have a PCO pattern in their ovaries during transvaginal ultrasound.
All participants are candidates for IVF having PCOS or having PCO patterns in their ovaries who wish to undertake IVM for the potential advantages that it holds. All cycles are proceeded by oral contraceptive use for cycle scheduling purposes. Priming is done with oral letrozole with the addition of 25-75 IU daily starting after 2 days of letrozole. HCG is given when several follicle have diameters 8 mm or greater and no follicles have diameters greater than 13 mm. Oocyte retrieval is done approximately 38 hours later. A Steiner-Tan needle is used for oocyte retrieval in a manner that minimizes the amount of time that an oocyte is out of the ovary and not in a controlled laboratory environment. Oocytes are assessed for maturity for up to 48 hours post retrieval. If mature, oocytes are injected with sperm using ICSI. Embryos are grown to blastocysts and all blastocyst are vitrified. Warmed cryo-preserved blastocyst are transferred using routine IVF protocols during a subsequent cycle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All | Experimental | Patients requiring IVF treatment with PCOS or a PCO pattern in their ovaries who wish to undertake IVM (as a variant of their IVF procedure) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| in vitro maturation of oocytes | Combination Product | Immature oocytes (rather than mature oocytes) are harvested as in IVF. These oocytes are allowed to mature in the laboratory before fertilization |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of treated patients having a clinical pregnancy | ultrasound evidence of pregnancy in uterus or tissue evidence of pregnancy | 12 weeks post transfer |
| Percentage of treated patients having an ongoing pregnancy | pregnancy with cardiac activity (by history or observations) after 12 weeks | 10 months post transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of retrieved oocytes which matured per patient | proportion of retrieved oocytes which are mature (polar body present) within 48 hours of retrieval | 2 days post retrieval |
| Percentage of retrieved oocytes which fertilized per patient |
| Measure | Description | Time Frame |
|---|---|---|
| Number of clinical pregnancies from subsequent transfers | Number of clinical pregnancies from all blastocyst transfers related to the retrieval | up to one year after transfer of last patient enrolled |
| Number of ongoing pregnancies from subsequent transfers |
Inclusion Criteria:
Exclusion Criteria:
genetic female with ovaries and uterus
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruce I Rose, MD, PhD | Contact | 904-260-0352 | brose@brownfertility.com | |
| Samuel Brown, MD | Contact | 904-260-0352 | sbrown@brownfertility.com |
| Name | Affiliation | Role |
|---|---|---|
| Bruce I Rose, MD, PhD | Brown Fertility | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown Fertility | Recruiting | Jacksonville | Florida | 32256 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25374658 | Background | Rose BI. The potential of letrozole use for priming in vitro maturation cycles. Facts Views Vis Obgyn. 2014;6(3):150-5. | |
| Background | Rose BI: The case for more active management of endometrial development in IVM: Decreasing the miscarriage rate and increasing the clinical pregnancy rate. Journal of Reproductive Endocrinology and Infertility, 14: 1-6, 2016 | ||
| 23644950 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 13, 2022 | |
| Unrelease | Jun 14, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 13, 2022 | Jun 14, 2022 | |||
| Jun 14, 2022 |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D059471 | In Vitro Oocyte Maturation Techniques |
| ID | Term |
|---|---|
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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Prospective series
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proportion of mature oocytes which display pronuclei
| 4 days post retrieval |
| Percentage of fertilized oocytes which divided | proportion of fertilized oocytes which become 2 or more cells | 6 days post retrieval |
| Percentage of fertilized oocytes which became blastocysts per patient | proportion of fertilized oocytes which form a fluid filled cavity | 8 days post retrieval |
| Percentage of patients who have a biochemical pregnancy after therir first transfer | proportion of patients with an hCG level greater than 5 measured post first transfer | 28 days post transfer |
Number of ongoing pregnancies from blastocyst transfers related to the retrieval
| up to one year after transfer of last patient enrolled |
| Background |
| Rose BI, Laky D. A comparison of the Cook single lumen immature ovum IVM needle to the Steiner-Tan pseudo double lumen flushing needle for oocyte retrieval for IVM. J Assist Reprod Genet. 2013 Jun;30(6):855-60. doi: 10.1007/s10815-013-0006-1. Epub 2013 May 5. |
| Jul 7, 2022 |
| 1 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |