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

October 31, 2019 updated by: Bruce Rose, MD

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of treated patients having a clinical pregnancy
Time Frame: 12 weeks post transfer
ultrasound evidence of pregnancy in uterus or tissue evidence of pregnancy
12 weeks post transfer
Percentage of treated patients having an ongoing pregnancy
Time Frame: 10 months post transfer
pregnancy with cardiac activity (by history or observations) after 12 weeks
10 months post transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of retrieved oocytes which matured per patient
Time Frame: 2 days post retrieval
proportion of retrieved oocytes which are mature (polar body present) within 48 hours of retrieval
2 days post retrieval
Percentage of retrieved oocytes which fertilized per patient
Time Frame: 4 days post retrieval
proportion of mature oocytes which display pronuclei
4 days post retrieval
Percentage of fertilized oocytes which divided
Time Frame: 6 days post retrieval
proportion of fertilized oocytes which become 2 or more cells
6 days post retrieval
Percentage of fertilized oocytes which became blastocysts per patient
Time Frame: 8 days post retrieval
proportion of fertilized oocytes which form a fluid filled cavity
8 days post retrieval
Percentage of patients who have a biochemical pregnancy after therir first transfer
Time Frame: 28 days post transfer
proportion of patients with an hCG level greater than 5 measured post first transfer
28 days post transfer

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of clinical pregnancies from subsequent transfers
Time Frame: up to one year after transfer of last patient enrolled
Number of clinical pregnancies from all blastocyst transfers related to the retrieval
up to one year after transfer of last patient enrolled
Number of ongoing pregnancies from subsequent transfers
Time Frame: up to one year after transfer of last patient enrolled
Number of ongoing pregnancies from blastocyst transfers related to the retrieval
up to one year after transfer of last patient enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bruce Rose, MD

Investigators

  • Principal Investigator: Bruce I Rose, MD, PhD, Brown Fertility

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 10, 2019

Primary Completion (ANTICIPATED)

April 1, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

July 9, 2019

First Submitted That Met QC Criteria

October 31, 2019

First Posted (ACTUAL)

November 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2019

Last Update Submitted That Met QC Criteria

October 31, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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