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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Bruce Rose, MD
Study ID
NCT04149496
Status
Recruiting
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Conditions

  • Polycystic Ovary Syndrome

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 38 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
May 10, 2019
Status verified
Oct 2019
Primary completion
Apr 1, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: All
    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)

Primary Outcome Measure

Percentage of treated patients having a clinical pregnancy [ Time Frame: 12 weeks post transfer ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brown FertilityJacksonvilleFlorida32256
Julius Varzoni, BS
[email protected]
904-260-0352
Meaghan German, RN
[email protected]
904-260-0352

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By research site
Brown Fertility· Jacksonville, FL

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