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NCT Number: NCT06619379

The Effect of Vaginal Speculum Type and Retention Time on Pregnancy Outcomes During The Embryo Transfer Process

Investigators aim to investigate possible affects of a speculum material and retention strategy on IVF pregnancy results. The study is planned as a prospective, randomized control trial. All of the clinical managements, including the embryo transfers, will be performed by the same gynecologist for homogeneity of the study. Only the cases with good implantation potentials are going to be included. Therefore, transfers with cleavage embryos and blastocysts rather than good and top quality will be excluded. All patients included to final statistical analysis will receive the same luteal support.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eurofertil

Bursa, Turkey (Türkiye)

About this study

Participants will be included among the 20 - 40 years old women applying to for IVF. Women with mullerian anomalies and couples with chromosomal abnormalities will be excluded. Histrory of recurrent implantation failure, thin endometrium will also be considered as exclusion criterias. Participants who are initially included in the study will be excluded either the demanded preimplantation genetik testing for aneuploidy optionally, or if the embryo transfer is performed under general anesthesia or the embryo transfer is recorded as difficult transfer.

The participants included in the study will be randomised for the speculum material ( metal or plastic) and also for the retention time of the speculum out of the vagina. Just immediately before applying the speculum to the patient, the material temperature will be measured and recorded with a thermometer capable of digital and object measurement.

All of the transfers will be performed with the same technique. After the embryo transfer is made and the transfer catheter is withdrawn, the speculum will be extracted according to the randomization. If the speculum is not extracted immediately, the chronometer will be started and the extraction will be done either in the 60. second or 420. second ( 7 minutes) according to the randomization . As there are two speculum materials and three retention time arms in the design, a total of 6 groups will be formed after crossover. Data gained in this way will be analyzed and their demographic data and embryological parameters will be evaluated and the implantation rates, pregnancy rates and clinical pregnancy rates of the patients will be determined.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • women aged 20-40
  • cases that good and top quality embryos are achieved for embryo trasnfer

Exclusion criteria

  • recurrent implantation failure
  • any known genetic problems of couple
  • any known mullein anomalies
  • PGT-A cases
  • thin endometrium

Treatment and study plan

Retention time of speculum

Other

According to the randomization, the speculum can be extracted :

  • just after the transfer catheter is withdrawn
  • 60 seconds after the transfer catheter is withdrawn
  • 420 second (7 minutes) after the catheter is withdrawn

Primary outcomes

  1. Pregnacy rates

    Time frame: Beta-HCG test will be taken on the 12th day of the embryo transfer

    Pregnancy rates is the primary outcome

Sponsors and collaborators

Lead sponsor

Eurofertil IVF Health Center

Other

Registry information

Acronym: Speculum

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 1, 2024
Registry last updated
Jul 25, 2025

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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