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

NCT04149496 | Recruiting FDA Device

• 1 other identifier: 18-49
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Percentage of retrieved oocytes which matured per patient

  2 days post retrieval

• Percentage of retrieved oocytes which fertilized per patient

  4 days post retrieval

• Percentage of fertilized oocytes which divided

  6 days post retrieval

• Percentage of fertilized oocytes which became blastocysts per patient

  8 days post retrieval

• Percentage of patients who have a biochemical pregnancy after therir first transfer

  28 days post transfer

Other Outcomes (2)

• Number of clinical pregnancies from subsequent transfers

  up to one year after transfer of last patient enrolled

• Number of ongoing pregnancies from subsequent transfers

  up to one year after transfer of last patient enrolled

Study Arms (1)

All

EXPERIMENTAL

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

Interventions

in vitro maturation of oocytes COMBINATION_PRODUCT

Immature oocytes (rather than mature oocytes) are harvested as in IVF. These oocytes are allowed to mature in the laboratory before fertilization

All

Eligibility Criteria

• Age: 18 Years - 38 Years
• Gender Eligibility Details: genetic female with ovaries and uterus
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• PCO pattern with \> 25 antral follicles
• AMH \> 3.5

You may not qualify if:

• BMI \> 35
• body morphology making transvaginal retrieval difficult or impossible
• complicating medical condition making pregnancy or IVF relatively contra-indicated

Sponsors & Collaborators

• Bruce Rose, MD: lead

Study Sites (1)

Brown Fertility

Jacksonville, Florida, 32256, United States

RECRUITING

Related Publications (3)

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

  PMID: 25374658 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 23644950 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

In Vitro Oocyte Maturation Techniques

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Bruce I Rose, MD, PhD

  Brown Fertility

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruce I Rose, MD, PhD

CONTACT

904-260-0352; brose@brownfertility.com

Samuel Brown, MD

CONTACT

904-260-0352; sbrown@brownfertility.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Model Details: Prospective series

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: November 4, 2019
• Study Start: May 10, 2019
• Primary Completion: April 1, 2023
• Study Completion: December 31, 2023
• Last Updated: November 4, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)