In Vitro Maturation of Human Eggs
1 other identifier
interventional
50
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Feb 2023
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2023
CompletedFirst Submitted
Initial submission to the registry
September 25, 2024
CompletedFirst Posted
Study publicly available on registry
October 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2030
October 9, 2024
September 1, 2024
6.5 years
September 25, 2024
October 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Oocyte maturation
Maturation rate of retrieved oocytes
27 hours
Embryo fertilization and development
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
Pregnancy following embryo transfer. HCG levels and ultrasound confirming IUP and heartrate.
6 months
Secondary Outcomes (1)
Live Birth
12 months
Study Arms (1)
Biphasic IVM Treatment
EXPERIMENTALBiphasic IVM of oocytes
Interventions
Immature oocytes will be retrieved from small ovarian follicles and matured overnight in the laboratory prior to undergoing fertilization and embryo culture.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- More than 2 failed IVF cycles
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Colorado Center for Reproductive Medicine
Lone Tree, Colorado, 80124, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2024
First Posted
October 9, 2024
Study Start
February 3, 2023
Primary Completion (Estimated)
July 31, 2029
Study Completion (Estimated)
August 30, 2030
Last Updated
October 9, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
IPD will be shared through publication in scientific journals.