Polycystic Ovary Syndrome
Conditions
Keywords
IVM, in vitro maturation, polycystic ovarian syndrome, PCOS, Steiner-Tan needle, oocyte maturation
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.
Interventions
COMBINATION_PRODUCTin 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
Sponsors
Bruce Rose, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective series
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of treated patients having an ongoing pregnancy | 10 months post transfer | pregnancy with cardiac activity (by history or observations) after 12 weeks |
| Percentage of treated patients having a clinical pregnancy | 12 weeks post transfer | ultrasound evidence of pregnancy in uterus or tissue evidence of pregnancy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of retrieved oocytes which fertilized per patient | 4 days post retrieval | proportion of mature oocytes which display pronuclei |
| Percentage of fertilized oocytes which became blastocysts per patient | 8 days post retrieval | proportion of fertilized oocytes which form a fluid filled cavity |
| Percentage of patients who have a biochemical pregnancy after therir first transfer | 28 days post transfer | proportion of patients with an hCG level greater than 5 measured post first transfer |
| Percentage of fertilized oocytes which divided | 6 days post retrieval | proportion of fertilized oocytes which become 2 or more cells |
| Percentage of retrieved oocytes which matured per patient | 2 days post retrieval | proportion of retrieved oocytes which are mature (polar body present) within 48 hours of retrieval |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of clinical pregnancies from subsequent transfers | up to one year after transfer of last patient enrolled | Number of clinical pregnancies from all blastocyst transfers related to the retrieval |
| Number of ongoing pregnancies from subsequent transfers | up to one year after transfer of last patient enrolled | Number of ongoing pregnancies from blastocyst transfers related to the retrieval |
Countries
United States
Contacts
Primary ContactBruce I Rose, MD, PhD
Backup ContactSamuel Brown, MD
Outcome results
None listed