Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- More than 2 failed IVF cycles
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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