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In Vitro Maturation of Human Eggs

C

Colorado Center for Reproductive Medicine

Status

Enrolling

Conditions

Infertility Poly Cystic Ovary
Healthy
IVF
Infertility of Tubal Origin
In Vitro Maturation
Infertility Female
IVM
PCOS
AMH
Infertility
Ovarian Reserve
PCOS (Polycystic Ovary Syndrome)

Treatments

Other: IVM

Study type

Interventional

Funder types

Other

Identifiers

NCT06633120
20141020

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

Female

Ages

Under 38 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Biphasic IVM Treatment
Experimental group
Description:
Biphasic IVM of oocytes
Treatment:
Other: IVM

Trial contacts and locations

1

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Central trial contact

Elizabeth A Jannaman, BS; Ye Yuan, PhD

Data sourced from clinicaltrials.gov

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