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NCT04149496 | RECRUITING | Polycystic Ovary Syndrome


IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer
Sponsor:

Bruce Rose, MD

Information provided by (Responsible Party):

Bruce Rose, MD

Brief 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.

Condition or disease

Polycystic Ovary Syndrome

Intervention/treatment

in vitro maturation of oocytes

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2019-05-10
Estimated Primary Completion Date : 2023-04-01
Estimated Study Completion Date : 2023-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 38 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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

IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer

Location Details

NCT04149496


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Locations


RECRUITING

United States, Florida

Brown Fertility

Jacksonville, Florida, United States, 32256

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