IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer (IVMprt)
Primary Purpose
Polycystic Ovary Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
in vitro maturation of oocytes
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring IVM, in vitro maturation, polycystic ovarian syndrome, PCOS, Steiner-Tan needle, oocyte maturation
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
Sites / Locations
- Brown FertilityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All
Arm Description
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)
Outcomes
Primary Outcome Measures
Percentage of treated patients having a clinical pregnancy
ultrasound evidence of pregnancy in uterus or tissue evidence of pregnancy
Percentage of treated patients having an ongoing pregnancy
pregnancy with cardiac activity (by history or observations) after 12 weeks
Secondary Outcome Measures
Percentage of retrieved oocytes which matured per patient
proportion of retrieved oocytes which are mature (polar body present) within 48 hours of retrieval
Percentage of retrieved oocytes which fertilized per patient
proportion of mature oocytes which display pronuclei
Percentage of fertilized oocytes which divided
proportion of fertilized oocytes which become 2 or more cells
Percentage of fertilized oocytes which became blastocysts per patient
proportion of fertilized oocytes which form a fluid filled cavity
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04149496
Brief Title
IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer
Acronym
IVMprt
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bruce Rose, MD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
IVM, in vitro maturation, polycystic ovarian syndrome, PCOS, Steiner-Tan needle, oocyte maturation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective series
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All
Arm Type
Experimental
Arm Description
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)
Intervention Type
Combination Product
Intervention Name(s)
in vitro maturation of oocytes
Intervention Description
Immature oocytes (rather than mature oocytes) are harvested as in IVF. These oocytes are allowed to mature in the laboratory before fertilization
Primary Outcome Measure Information:
Title
Percentage of treated patients having a clinical pregnancy
Description
ultrasound evidence of pregnancy in uterus or tissue evidence of pregnancy
Time Frame
12 weeks post transfer
Title
Percentage of treated patients having an ongoing pregnancy
Description
pregnancy with cardiac activity (by history or observations) after 12 weeks
Time Frame
10 months post transfer
Secondary Outcome Measure Information:
Title
Percentage of retrieved oocytes which matured per patient
Description
proportion of retrieved oocytes which are mature (polar body present) within 48 hours of retrieval
Time Frame
2 days post retrieval
Title
Percentage of retrieved oocytes which fertilized per patient
Description
proportion of mature oocytes which display pronuclei
Time Frame
4 days post retrieval
Title
Percentage of fertilized oocytes which divided
Description
proportion of fertilized oocytes which become 2 or more cells
Time Frame
6 days post retrieval
Title
Percentage of fertilized oocytes which became blastocysts per patient
Description
proportion of fertilized oocytes which form a fluid filled cavity
Time Frame
8 days post retrieval
Title
Percentage of patients who have a biochemical pregnancy after therir first transfer
Description
proportion of patients with an hCG level greater than 5 measured post first transfer
Time Frame
28 days post transfer
Other Pre-specified Outcome Measures:
Title
Number of clinical pregnancies from subsequent transfers
Description
Number of clinical pregnancies from all blastocyst transfers related to the retrieval
Time Frame
up to one year after transfer of last patient enrolled
Title
Number of ongoing pregnancies from subsequent transfers
Description
Number of ongoing pregnancies from blastocyst transfers related to the retrieval
Time Frame
up to one year after transfer of last patient enrolled
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
genetic female with ovaries and uterus
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruce I Rose, MD, PhD
Phone
904-260-0352
Email
brose@brownfertility.com
First Name & Middle Initial & Last Name or Official Title & Degree
Samuel Brown, MD
Phone
904-260-0352
Email
sbrown@brownfertility.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce I Rose, MD, PhD
Organizational Affiliation
Brown Fertility
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown Fertility
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julius Varzoni, BS
Phone
904-260-0352
Email
jvarzoni@brownfertility.com
First Name & Middle Initial & Last Name & Degree
Meaghan German, RN
Phone
904-260-0352
Email
mgerman@brownfertility.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25374658
Citation
Rose BI. The potential of letrozole use for priming in vitro maturation cycles. Facts Views Vis Obgyn. 2014;6(3):150-5.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
23644950
Citation
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.
Results Reference
background
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IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer
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