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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Combination Product: in vitro maturation of oocytes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective series
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All<br>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) | Combination Product: in vitro maturation of oocytes<br>* Immature oocytes (rather than mature oocytes) are harvested as in IVF. These oocytes are allowed to mature in the laboratory before fertilization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of treated patients having a clinical pregnancy | ultrasound evidence of pregnancy in uterus or tissue evidence of pregnancy | 12 weeks post transfer | 
| Percentage of treated patients having an ongoing pregnancy | pregnancy with cardiac activity (by history or observations) after 12 weeks | 10 months post transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of retrieved oocytes which matured per patient | proportion of retrieved oocytes which are mature (polar body present) within 48 hours of retrieval | 2 days post retrieval | 
| Percentage of retrieved oocytes which fertilized per patient | proportion of mature oocytes which display pronuclei | 4 days post retrieval | 
| Percentage of fertilized oocytes which divided | proportion of fertilized oocytes which become 2 or more cells | 6 days post retrieval | 
| Percentage of fertilized oocytes which became blastocysts per patient | proportion of fertilized oocytes which form a fluid filled cavity | 8 days post retrieval | 
| 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 | 28 days post transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVM, in vitro maturation, polycystic ovarian syndrome, PCOS, Steiner-Tan needle, oocyte maturation