Recruiting

IVM with Low Cost Priming

Sponsor:

Bruce Rose, MD

Code:

NCT04149496

Conditions

Polycystic Ovary Syndrome

Eligibility Criteria

Sex: Female

Age: 18 - 38

Healthy Volunteers: Not accepted

Interventions

in vitro maturation of oocytes

Study Details

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.

Conditions

Polycystic Ovary Syndrome

Study ID

NCT04149496

Start date

May 10, 2019

Status verified date

Oct, 2019

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Apr 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 38

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: All

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)

Interventions

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

Primary outcome measure

  • Percentage of treated patients having a clinical pregnancy [ Time Frame: 12 weeks post transfer ]
  • Percentage of treated patients having an ongoing pregnancy [ Time Frame: 10 months post transfer ]

Central Contacts and Locations

Central contacts

Bruce I Rose, MD, PhD

904-260-0352brose@brownfertility.com

Samuel Brown, MD

904-260-0352sbrown@brownfertility.com

Locations

Brown Fertility

Recruiting

Jacksonville, Florida, United States, 32256

Contacts

Julius Varzoni, BS

904-260-0352jvarzoni@brownfertility.com

Meaghan German, RN

904-260-0352mgerman@brownfertility.com

More Information

Sponsor

Bruce Rose, MD

Last update posted

Nov 4, 2019

Last verified

Oct, 2019

Keywords

  • IVM
  • in vitro maturation
  • polycystic ovarian syndrome
  • PCOS
  • Steiner-Tan needle
  • oocyte maturation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bruce Rose, MD on 2019-11-04.