AMH, Healthy, Infertility, Infertility Female, Infertility of Tubal Origin, Infertility Poly Cystic Ovary, In Vitro Maturation, IVF, IVM, Ovarian Reserve, PCOS, PCOS (Polycystic Ovary Syndrome)
Conditions
Keywords
IVM, Infertility, PCOS, IVF
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
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.
Interventions
OTHERIVM
Immature oocytes will be retrieved from small ovarian follicles and matured overnight in the laboratory prior to undergoing fertilization and embryo culture.
Sponsors
Colorado Center for Reproductive Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 38 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oocyte maturation | 27 hours | Maturation rate of retrieved oocytes |
| Embryo fertilization and development | 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 |
| Pregnancy | 6 months | Pregnancy following embryo transfer. HCG levels and ultrasound confirming IUP and heartrate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Live Birth | 12 months | Birth information (sex of infant, status, weight, and any complications) will be collected via patient contact when possible. |
Countries
United States
Contacts
Primary ContactElizabeth A Jannaman, BS
Backup ContactYe Yuan, PhD
Outcome results
None listed