Heated and Non Heated Ovarian Aspiration Needle Protocol

NCT05683639 | Completed

• 1 other identifier: 60504522.7.0000.5327
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief Summary

The success of IVF is influenced by factors as cause of infertility and age. Furthermore, there is a large influence of external factors, from the laboratory environment, handling and cultivation of gametes and embryos. The existence of factors capable of affecting the success of the treatment lead to the need of a quality control to attenuate the unfavorable effects. After ovarian stimulation, follicular aspiration is performed. At this moment, factors such as aspiration technique, needle type and temperature are the main variables to be controlled. It is known that oocytes are the more sensitive cells to temperature fluctuations. Currently, the standard protocol for follicular aspiration does not include the warming of the aspiration needle. However, due to the existing evidence in the literature, that the follicular fluid temperature drops during the aspiration procedure, this work aims to evaluate the influence of a pre warming of the aspiration needle as a new protocol.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• normal fertilization rate

  Fertilization will be confirmed through the visualization of the presence of two pronuclei

  16 to 18 hours after fertilization procedure

Secondary Outcomes (4)

• number of oocyte retrieved

  immediately after ovarian aspiration procedure

• number of mature oocyte

  3 hours post ovarian aspiration

• oocyte damage rate

  3 hours post ovarian aspiration

• abnormal fertilization rate

  16 to 18 hours after fertilization procedure

Study Arms (2)

Standard protocol

NO INTERVENTION

The standard protocol comprises no heating of the aspiration needle.

Warming protocol

EXPERIMENTAL

The aspiration needle will be warm-up overnight the day before the oocyte pick-up procedure

Other: warming of the follicular aspiration needle

Interventions

warming of the follicular aspiration needle OTHER

the follicular aspiration needle will be heated overnight before the ovarian aspiration procedure.

Warming protocol

Eligibility Criteria

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

You may qualify if:

• All women submitted to IVF cycles

You may not qualify if:

• Women submitted to follicular aspiration due to oocyte cryopreservation
• Patients without oocyte retrieved
• Patients without mature oocyte retrieved
• Procedures with needle replacement

Sponsors & Collaborators

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

Study Sites (1)

Insemine Human Reproduction Centre

Porto Alegre, Rio Grande do Sul, 91330-001, Brazil

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

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

Study Officials

• João da 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 13, 2023
• Study Start: January 2, 2023
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)