In Vitro Maturation of Human Eggs

Not Applicable

Recruiting

• Conditions: AMH; Healthy; PCOS; PCOS (Polycystic Ovary Syndrome); Ovarian Reserve; Infertility; Infertility Female; Infertility of Tubal Origin; Infertility Poly Cystic Ovary; In Vitro Maturation
• Interventions: Other: IVM

• Registration Number: NCT06633120
• Lead 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

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 Timeline

• Study Start: 2023-02-03
• Status Verified: 2024-09
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Study First Posted: 2024-10-09
• Last Update Posted: 2024-10-09
• Primary Completion: 2029-07-31
• Study Completion: 2030-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biphasic IVM Treatment	IVM	Biphasic IVM of oocytes

Primary Outcome Measures

Name	Time	Method
Oocyte maturation	27 hours	Maturation rate of retrieved oocytes
Embryo fertilization and development	7 days	Number of embryos that fertilize and develop after ICSI. Blastocysts will be biopsied and frozen on days 5, 6, and 7 of development
Pregnancy	6 months	Pregnancy following embryo transfer. HCG levels and ultrasound confirming IUP and heartrate.

Secondary Outcome Measures

Name	Time	Method
Live Birth	12 months	Birth information (sex of infant, status, weight, and any complications) will be collected via patient contact when possible.

Trial Locations

Locations (1)

Colorado Center for Reproductive Medicine; 🇺🇸 Lone Tree, Colorado, United States