Actively Recruiting

Phase Not Applicable
Age: 0 - 38Years
FEMALE
ID06633120

In Vitro Maturation of Human Eggs for Infertility Treatment at Colorado Center for Reproductive Medicine

Led by Colorado Center for Reproductive Medicine · Updated on 2024-10-09

50

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating in vitro maturation (IVM) of human eggs as a fertility treatment option for women diagnosed with polycystic ovary syndrome (PCOS), polycystic ovaries, or those with good ovarian reserve who experience infertility. This study aims to assess the process and outcomes of IVM, which uses fewer hormones than traditional IVF, potentially making it more affordable and with fewer side effects. The study is sponsored by the Colorado Center for Reproductive Medicine. Participants will first undergo a complete IVF workup to qualify. Qualified women will receive a cycle of low-dose ovarian stimulation for three days, followed by retrieval of immature eggs from the ovaries using ultrasound-guided aspiration. These eggs are matured overnight in the lab, then fertilized via intracytoplasmic sperm injection (ICSI) and cultured to the blastocyst stage. The first 14 blastocysts will be biopsied for preimplantation genetic testing for aneuploidies (PGT-A), with options for additional biopsies. The study includes preparation and the first frozen embryo transfer (FET), along with some medication and testing through the first pregnancy test. During the study, participants will attend visits for baseline assessments, stimulation, egg retrieval, fertilization, embryo culture, biopsy, and embryo transfer. Researchers will monitor egg maturation at 27 hours, embryo fertilization and development over 7 days, and pregnancy outcomes up to 6 months. Live birth outcomes will also be tracked for up to 12 months. The study covers anesthesia, some medications, and fertility testing as part of the treatment cycle, with ongoing follow-up to assess success and safety.

CONDITIONS

Brief Title

In Vitro Maturation of Human Eggs

Who Can Participate

Age: 0 - 38Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Agree to have embryos biopsied for preimplantation genetic testing
  • Intend to perform embryo transfer within 4 months after completing the IVM cycle
  • Paternal (or donor) age under 45, ejaculated sperm collection only (partner frozen and donor sperm acceptable)
  • Sperm morphology (strict criteria) greater than 1%, motility greater than 20%, and sperm count greater than 10 million per ml
Not Eligible

You will not qualify if you...

  • More than 2 failed IVF cycles

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 1 week

Participants undergo a three day low dose stimulation followed by egg retrieval. Immature oocytes are matured overnight in the laboratory, fertilized via ICSI, and cultured to the blastocyst stage. Biopsy of blastocysts and preparation for the first frozen embryo transfer is included.

Multiple visits including stimulation, egg retrieval, fertilization, and embryo transfer preparation

Follow-up

Duration - Up to 6 months

Participants receive testing through the first pregnancy test after frozen embryo transfer.

1 to 2 visits for pregnancy testing and monitoring

Trial Site Locations

Total: 1 location

1

Colorado Center for Reproductive Medicine

Lone Tree, Colorado, United States, 80124

Actively Recruiting

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Research Team

E

Elizabeth A Jannaman, BS

Y

Ye Yuan, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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