Heated and Non Heated Ovarian Aspiration Needle Protocol

NCT ID: NCT05683639

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-02
• Study Completion Date: 2023-06-01

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.

Detailed Description

The estimated sample was 600 oocytes for each group, totaling a minimum of 1200 oocytes, considering a fertilization rate of 65% in the control group and 73% in the study group, for a power of 80% and p alpha 5%, i.e. , an increase of more than 10% between groups. As there is no data in the literature, when the investigators have this sample an interim analysis to evaluate the data will be performed. The investigators consider 10% a reasonable difference that can (with this sample size) increase by 48 embryos and a possible increase of 7 pregnancies within this sample. Bearing in mind that the average number of oocytes retrieved per patient is 6 oocytes, the investigators estimate that 200 patients will be needed to reach the calculated sample number.

The warm-up protocol will be applied by the embryologists, which consists of heating the follicular aspiration needle to 37 Celsius, overnight, the day before the day of the ovarian aspiration procedure.

The variables that will be compared between the studied groups are the rates of oocyte retrieval, maturity (MII), fracture, atresia, fertilization rates and discarded embryos.

Continuous variables will be analyzed using Student's t test if they have normal distribution, for comparison of means between two independent groups or the Wilcoxon-Mann-Whitney U test if not parametric. Differences between groups will be considered significant when p<0.05.

Conditions

Infertility, Female

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Standard protocol

The standard protocol comprises no heating of the aspiration needle.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Warming protocol

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

Group Type: EXPERIMENTAL

warming of the follicular aspiration needle

Intervention Type: OTHER

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

Interventions

warming of the follicular aspiration needle

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All women submitted to IVF cycles

Exclusion Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Guedes da Luz Médicos Associados Sociedade Simples LTDA

UNKNOWN

Sponsor Role: collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

João da Cunha Filho, PhD

Role: STUDY_DIRECTOR

Hospital de Clínicas de Porto Alegre

Locations

Insemine Human Reproduction Centre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

60504522.7.0000.5327

Identifier Type: -

Identifier Source: org_study_id