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NCT06633120 | RECRUITING | Healthy

In Vitro Maturation of Human Eggs
Sponsor:

Colorado Center for Reproductive Medicine

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

Condition or disease

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

Intervention/treatment

IVM

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : In Vitro Maturation of Human Eggs
Actual Study Start Date : 2023-02-03
Estimated Primary Completion Date : 2029-07-31
Estimated Study Completion Date : 2030-08-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: to 38 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
In Vitro Maturation of Human Eggs

Location Details

NCT06633120

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

Colorado Center for Reproductive Medicine

Lone Tree, Colorado, United States, 80124