IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: in vitro maturation of oocytes.
- Who it may be relevant to
- Registry conditions: Polycystic Ovary Syndrome. Basic parameters: 18 years — 38 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Combination product in 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
Primary outcome measures
- Percentage of treated patients having a clinical pregnancy [Time frame: 12 weeks post transfer]
- Percentage of treated patients having an ongoing pregnancy [Time frame: 10 months post transfer]
Secondary outcome measures (5)
- 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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Brown Fertility — Jacksonville
Publications
- Rose BI. The potential of letrozole use for priming in vitro maturation cycles. Facts Views Vis Obgyn. 2014;6(3):150-5. PMID 25374658
- 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. PMID 23644950
Identifiers
NCT: NCT04149496 · 18-49