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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biphasic IVM Treatment | Experimental | Biphasic IVM of oocytes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVM | Other | Immature oocytes will be retrieved from small ovarian follicles and matured overnight in the laboratory prior to undergoing fertilization and embryo culture. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Live Birth | Birth information (sex of infant, status, weight, and any complications) will be collected via patient contact when possible. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth A Jannaman, BS | Contact | 303-788-8300 | 1123 | EJannaman@CCRMIVF.com |
| Ye Yuan, PhD | Contact | 720-895-8306 | YYuan@ccrmivf.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Center for Reproductive Medicine | Recruiting | Lone Tree | Colorado | 80124 | United States |
IPD will be shared through publication in scientific journals.
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D007246 | Infertility |
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |