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

Polycystic Ovary Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04149496
• Other study ID #: 18-49
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2019
• Source: Brown Fertility
• Contact: Bruce I Rose, MD, PhD
• Phone: 904-260-0352
• Email: brose[@]brownfertility.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Combination Product:
• in 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

Locations

Country	Name	City	State
United States	Brown Fertility	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bruce Rose, MD

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Rose BI. The potential of letrozole use for priming in vitro maturation cycles. Facts Views Vis Obgyn. 2014;6(3):150-5. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of clinical pregnancies from subsequent transfers	Number of clinical pregnancies from all blastocyst transfers related to the retrieval	up to one year after transfer of last patient enrolled
Other	Number of ongoing pregnancies from subsequent transfers	Number of ongoing pregnancies from blastocyst transfers related to the retrieval	up to one year after transfer of last patient enrolled
Primary	Percentage of treated patients having a clinical pregnancy	ultrasound evidence of pregnancy in uterus or tissue evidence of pregnancy	12 weeks post transfer
Primary	Percentage of treated patients having an ongoing pregnancy	pregnancy with cardiac activity (by history or observations) after 12 weeks	10 months post transfer
Secondary	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
Secondary	Percentage of retrieved oocytes which fertilized per patient	proportion of mature oocytes which display pronuclei	4 days post retrieval
Secondary	Percentage of fertilized oocytes which divided	proportion of fertilized oocytes which become 2 or more cells	6 days post retrieval
Secondary	Percentage of fertilized oocytes which became blastocysts per patient	proportion of fertilized oocytes which form a fluid filled cavity	8 days post retrieval
Secondary	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