Clinical trial NCT04149496: IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer
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
Overall status: RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: IVM
in vitro maturation
polycystic ovarian syndrome
PCOS
Steiner-Tan needle
oocyte maturation
Lead sponsor: Brown Fertility
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective series
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of treated patients having a clinical pregnancy
timeFrame: 12 weeks post transfer
measure: Percentage of treated patients having an ongoing pregnancy
timeFrame: 10 months post transfer
Secondary outcomes:
measure: Percentage of retrieved oocytes which matured per patient
timeFrame: 2 days post retrieval
measure: Percentage of retrieved oocytes which fertilized per patient
timeFrame: 4 days post retrieval
measure: Percentage of fertilized oocytes which divided
timeFrame: 6 days post retrieval
measure: Percentage of fertilized oocytes which became blastocysts per patient
timeFrame: 8 days post retrieval
measure: Percentage of patients who have a biochemical pregnancy after therir first transfer
timeFrame: 28 days post transfer
Other outcomes:
measure: Number of clinical pregnancies from subsequent transfers
timeFrame: up to one year after transfer of last patient enrolled
measure: Number of ongoing pregnancies from subsequent transfers
timeFrame: up to one year after transfer of last patient enrolled
Locations:
city: Jacksonville
country: United States
facility: Brown Fertility
state: Florida
Study officials:
affiliation: Brown Fertility
name: Bruce I Rose, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rose BI. The potential of letrozole use for priming in vitro maturation cycles. Facts Views Vis Obgyn. 2014;6(3):150-5.
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
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.