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Trial Title:
In Vitro Maturation of Human Eggs
NCT ID:
NCT06633120
Condition:
Healthy
PCOS
PCOS (Polycystic Ovary Syndrome)
Ovarian Reserve
Infertility
Infertility Female
Infertility of Tubal Origin
Infertility Poly Cystic Ovary
AMH
In Vitro Maturation
IVM
IVF
Conditions: Official terms:
Polycystic Ovary Syndrome
Infertility
Infertility, Female
Conditions: Keywords:
IVM
Infertility
PCOS
IVF
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
IVM
Description:
Immature oocytes will be retrieved from small ovarian follicles and matured overnight in
the laboratory prior to undergoing fertilization and embryo culture.
Arm group label:
Biphasic IVM Treatment
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
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
N/A
Maximum age:
38 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Colorado Center for Reproductive Medicine
Address:
City:
Lone Tree
Zip:
80124
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rachel Study Coordinator
Phone:
303-788-8300
Phone ext:
1769
Email:
RachelM@colocrm.com
Contact backup:
Last name:
Ye Yuan, PhD
Start date:
February 3, 2023
Completion date:
August 30, 2030
Lead sponsor:
Agency:
Colorado Center for Reproductive Medicine
Agency class:
Other
Source:
Colorado Center for Reproductive Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06633120
