Evaluation of Different Culture Media for in Vitro Fertilization

NCT05676515 | Completed

• 1 other identifier: 60500922.2.0000.5327
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Under in vivo conditions, human gametes and embryos are exposed to fluids in the fallopian tubes, where fertilization occurs, and in the uterus, the site of embryonic implantation. The composition of these microenvironments is extremely complex and diverse. On the other hand, infertile couples who need in vitro fertilization treatments have their gametes and embryos cultured for a few days in commercial culture media. The composition of the media used in assisted reproduction laboratories varies according to the manufacturer and culture strategy. It is already known that the exposure of embryos to different concentrations of nutrients can affect the effectiveness of in vitro fertilization treatments, such as the fertilization rate, embryonic development speed, implantation rate, gestation, abortion, newborn weight, among other factors. Although these aspects are much discussed in the literature, there is still no consensus regarding the choice of a specific culture medium. Thus, the present study aims to evaluate the influence of three commercial culture media on the fertilization rate and embryonic quality through a prospective randomized clinical trial using sibling oocytes from patients undergoing in vitro fertilization cycles.

Conditions

Infertility, Female

Keywords

culture media; fertilization

Outcome Measures

Primary Outcomes (1)

• day three good quality embryo rate

  day three A/B embryos

  64-67 hours

Secondary Outcomes (1)

• fertilization

  16-18 hours

Study Arms (3)

culture media of fabricant A

ACTIVE COMPARATOR

use of culture media of fabricant A

Other: culture media

culture media of fabricant B

ACTIVE COMPARATOR

use of culture media of fabricant B

Other: culture media

culture media of fabricant C

ACTIVE COMPARATOR

use of culture media of fabricant C

Other: culture media

Interventions

culture media OTHER

spliting of biological material and use of three culture media

culture media of fabricant A; culture media of fabricant B; culture media of fabricant C

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• IVF/ICSI cycles;
• At least three oocytes retrieved;
• Consent term signed;

You may not qualify if:

• Less than three oocytes for fertilization.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Guedes da Luz Médicos Associados Sociedade Simples LTDA: collaborator

Study Sites (1)

Insemine

Porto Alegre, Rio Grande do Sul, 91330001, Brazil

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Culture Media

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Laboratory Chemicals; Specialty Uses of Chemicals; Chemical Actions and Uses; Equipment and Supplies

Study Officials

• João Sabino Cunha Filho, PhD

  Hospital de Clínicas de Porto Alegre

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 9, 2023
• Study Start: October 10, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 31, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

BR (1)