In Vitro Maturation of Human Eggs

Colorado Center for Reproductive Medicine50 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy PCOS

Eligibility

Sex: FEMALEMax age: 38 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Oocyte maturation

Maturation rate of retrieved oocytes

Time frame: 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

Time frame: 7 days

Pregnancy

Pregnancy following embryo transfer. HCG levels and ultrasound confirming IUP and heartrate.

Time frame: 6 months

Secondary Outcomes

Live Birth

Birth information (sex of infant, status, weight, and any complications) will be collected via patient contact when possible.

Time frame: 12 months