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Completed

NCT Number: NCT05683639

Heated and Non Heated Ovarian Aspiration Needle Protocol

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Insemine Human Reproduction Centre

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

warming of the follicular aspiration needle

Other

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

Primary outcomes

  1. normal fertilization rate

    Time frame: 16 to 18 hours after fertilization procedure

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

Secondary outcomes

  1. number of oocyte retrieved

    Time frame: immediately after ovarian aspiration procedure

    the total number of oocytes captured in the ovarian aspiration procedure

  2. number of mature oocyte

    Time frame: 3 hours post ovarian aspiration

    total number of MII

  3. oocyte damage rate

    Time frame: 3 hours post ovarian aspiration

    the number of fractured oocytes or atresia

  4. abnormal fertilization rate

    Time frame: 16 to 18 hours after fertilization procedure

    the total number of zygotes with three or more pronuclei

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Guedes da Luz Médicos Associados Sociedade Simples LTDA

Registry information

Official study title

Randomized Clinical Trial in Women Submitted to in Vitro Fertilization: Warming Versus Not Warming of the Follicular Aspiration Needle.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 13, 2023
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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