Recruiting

In Vitro Maturation

Sponsor:

Colorado Center for Reproductive Medicine

Code:

NCT06633120

Conditions

Healthy

PCOS

PCOS (Polycystic Ovary Syndrome)

Ovarian Reserve

Infertility

Eligibility Criteria

Sex: Female

Age: 0 - 38

Healthy Volunteers: Not accepted

Interventions

IVM

Study Details

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

Conditions

Healthy

PCOS

PCOS (Polycystic Ovary Syndrome)

Ovarian Reserve

Infertility

Study ID

NCT06633120

Start date

Feb 3, 2023

Status verified date

Sep, 2024

Completion date

Aug 30, 2030

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0 - 38

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Biphasic IVM Treatment

Biphasic IVM of oocytes

Interventions

IVM

Immature oocytes will be retrieved from small ovarian follicles and matured overnight in the laboratory prior to undergoing fertilization and embryo culture.

Primary outcome measure

  • Oocyte maturation [ Time Frame: 27 hours ]
  • Embryo fertilization and development [ Time Frame: 7 days ]
  • Pregnancy [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Elizabeth A Jannaman, BS

303-788-8300EJannaman@CCRMIVF.com

Ye Yuan, PhD

720-895-8306YYuan@ccrmivf.com

Locations

Colorado Center for Reproductive Medicine

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

Rachel Study Coordinator

303-788-8300RachelM@colocrm.com

More Information

Sponsor

Colorado Center for Reproductive Medicine

Last update posted

Oct 9, 2024

Last verified

Sep, 2024

Keywords

  • IVM
  • Infertility
  • PCOS
  • IVF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by Colorado Center for Reproductive Medicine on 2024-10-09.