In Vitro Maturation of Human Eggs

October 7, 2024 updated by: Colorado Center for Reproductive Medicine
CCRM Fertility, a global pioneer in fertility treatment, research and science, is seeking participants for a new study on in vitro maturation (IVM). IVM requires less hormones to stimulate the ovaries than IVF, making it more affordable than IVF with fewer side effects. Participants that qualify for the study will receive a free cycle of IVM treatment at CCRM Fertility and including a new patient consultation, fertility testing, preimplantation genetic testing for aneuploidies (PGT-A), anesthesia and some medication

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will undergo a complete IVF workup to qualify for study. Once passing their baseline appointment patients will undergo a three day low dose stimulation followed by egg retrieval 18-22 hours post last medication dosage. Immature oocytes will be retrieved from the ovaries via ultrasound guided TV aspiration and matured overnight in the laboratory. Mature oocytes will be fertilized via ICSI the following day and cultured to the blastocyst stage. Biopsy of the first 14 blastocysts are included with this package, patients have the option biopsy additional embryos if available. Biopsies will be sent for PGTA testing. This study also includes preparation for and the first frozen embryo transfer. Some FET medication is included as well as testing through the first pregnancy test.

Study Type

Interventional

Enrollment (Estimated)

50

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

  • United States
    • Colorado
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Colorado Center for Reproductive Medicine
        • Contact:
        • Contact:
          • Ye Yuan, PhD

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Infertile women diagnosed with PCOS or polycystic ovaries, or infertile women with good ovarian reserve
  • Antral follicle count (AFC) greater than 24
  • AMH greater than 3.5 ng/ml
  • Body Mass Index less than 35
  • Accept to have embryos biopsied for PGT
  • Intend to perform embryo transfer within 4 months after completing the IVM cycle
  • Paternal (or donor) age <45, ejaculated sperm collection only (partner frozen and donor sperm acceptable), sperm morphology (strict criteria) >1%, motility > 20% and sperm count > 10 million per ml (so samples can be prepared through standard procedure)

Exclusion Criteria:

  • More than 2 failed IVF cycles

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biphasic IVM Treatment
Biphasic IVM of oocytes
Other: IVM
Immature oocytes will be retrieved from small ovarian follicles and matured overnight in the laboratory prior to undergoing fertilization and embryo culture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oocyte maturation
Time Frame: 27 hours
Maturation rate of retrieved oocytes
27 hours
Embryo fertilization and development
Time Frame: 7 days
Number of embryos that fertilize and develop after ICSI. Blastocysts will be biopsied and frozen on days 5, 6, and 7 of development
7 days
Pregnancy
Time Frame: 6 months
Pregnancy following embryo transfer. HCG levels and ultrasound confirming IUP and heartrate.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live Birth
Time Frame: 12 months
Birth information (sex of infant, status, weight, and any complications) will be collected via patient contact when possible.
12 months

Collaborators and Investigators

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

Sponsor

Colorado Center for Reproductive Medicine

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)

February 3, 2023

Primary Completion (Estimated)

July 31, 2029

Study Completion (Estimated)

August 30, 2030

Study Registration Dates

First Submitted

September 25, 2024

First Submitted That Met QC Criteria

October 7, 2024

First Posted (Estimated)

October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

October 9, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20141020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be shared through publication in scientific journals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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