Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06633120

In Vitro Maturation of Human Eggs

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

Up to 38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Colorado Center for Reproductive Medicine

Lone Tree, Colorado, 80124, United States

Location status: Recruiting

Location contact

Rachel Study Coordinator

CONTACT

[email protected]

303-788-8300 ext. 1769

Ye Yuan, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IVM

Other

Immature oocytes will be retrieved from small ovarian follicles and matured overnight in the laboratory prior to undergoing fertilization and embryo culture.

Primary outcomes

  1. Oocyte maturation

    Time frame: 27 hours

    Maturation rate of retrieved oocytes

  2. 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

  3. Pregnancy

    Time frame: 6 months

    Pregnancy following embryo transfer. HCG levels and ultrasound confirming IUP and heartrate.

Secondary outcomes

  1. Live Birth

    Time frame: 12 months

    Birth information (sex of infant, status, weight, and any complications) will be collected via patient contact when possible.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth A Jannaman, BS

CONTACT

[email protected]

303-788-8300 ext. 1123

Ye Yuan, PhD

CONTACT

[email protected]

720-895-8306

Sponsors and collaborators

Lead sponsor

Colorado Center for Reproductive Medicine

Other

Registry information

Important dates

Study start
2023
Primary completion
2029
Study completion
2030
First posted
Oct 9, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.