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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Immature oocytes (rather than mature oocytes) are harvested as in IVF. These oocytes are allowed to mature in the laboratory before fertilization
Brown Fertility
Jacksonville, Florida, United States
RECRUITINGPercentage of treated patients having a clinical pregnancy
ultrasound evidence of pregnancy in uterus or tissue evidence of pregnancy
Time frame: 12 weeks post transfer
Percentage of treated patients having an ongoing pregnancy
pregnancy with cardiac activity (by history or observations) after 12 weeks
Time frame: 10 months post transfer
Percentage of retrieved oocytes which matured per patient
proportion of retrieved oocytes which are mature (polar body present) within 48 hours of retrieval
Time frame: 2 days post retrieval
Percentage of retrieved oocytes which fertilized per patient
proportion of mature oocytes which display pronuclei
Time frame: 4 days post retrieval
Percentage of fertilized oocytes which divided
proportion of fertilized oocytes which become 2 or more cells
Time frame: 6 days post retrieval
Percentage of fertilized oocytes which became blastocysts per patient
proportion of fertilized oocytes which form a fluid filled cavity
Time frame: 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
Time frame: 28 days post transfer
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