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A Prospective Series of IVF Cases Utilizing in Vitro Maturation (IVM) With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Embryo Transfer Using a Subsequent Frozen Embryo Transfer Cycle

NCT ID: NCT04149496Sponsor: Bruce Rose, MDLast updated: 2019-11-04

Summary

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.

Detailed description

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.

Arms & interventions

  • Combination Productin vitro maturation of oocytes

    Immature oocytes (rather than mature oocytes) are harvested as in IVF. These oocytes are allowed to mature in the laboratory before fertilization

Outcome measures

Primary

  • Percentage 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

Secondary

  • Percentage of retrieved oocytes which matured per patient

    Time frame: 2 days post retrieval

  • Percentage of retrieved oocytes which fertilized per patient

    Time frame: 4 days post retrieval

  • Percentage of fertilized oocytes which divided

    Time frame: 6 days post retrieval

  • Percentage of fertilized oocytes which became blastocysts per patient

    Time frame: 8 days post retrieval

  • Percentage of patients who have a biochemical pregnancy after therir first transfer

    Time frame: 28 days post transfer

Eligibility criteria

Sex: FemaleAge: 18 Years to 38 YearsHealthy volunteers: No
Inclusion Criteria: * PCO pattern with \> 25 antral follicles * AMH \> 3.5 Exclusion Criteria: * BMI \> 35 * body morphology making transvaginal retrieval difficult or impossible * complicating medical condition making pregnancy or IVF relatively contra-indicated

Study locations (1)

Brown Fertility

Jacksonville, Florida, 32256

Recruiting
Julius Varzoni, BS · Contact
Meaghan German, RN · Contact

References

  • Rose BI. The potential of letrozole use for priming in vitro maturation cycles. Facts Views Vis Obgyn. 2014;6(3):150-5.(PubMed)
  • 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
  • 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.(PubMed)
IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer | Cancerify