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

July 22, 2025 updated by: Elif Güler Ergin, Eurofertil IVF Health Center
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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 After the embryo transfer is made and the transfer catheter is withdrawn, the speculum will be extracted according to the randomization.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.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey
        • Eurofertil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Plastic speculum
Metal speculum
Other: Retention time of speculum

According to the randomization, the speculum can be extracted :

  1. just after the transfer catheter is withdrawn
  2. 60 seconds after the transfer catheter is withdrawn
  3. 420 second (7 minutes) after the catheter is withdrawn
Other: Metal speculum
Metal speculum will be used in this group
Other: Retention time of speculum

According to the randomization, the speculum can be extracted :

  1. just after the transfer catheter is withdrawn
  2. 60 seconds after the transfer catheter is withdrawn
  3. 420 second (7 minutes) after the catheter is withdrawn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnacy rates
Time Frame: Beta-HCG test will be taken on the 12th day of the embryo transfer
Pregnancy rates is the primary outcome
Beta-HCG test will be taken on the 12th day of the embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eurofertil IVF Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2025

Last Update Submitted That Met QC Criteria

July 22, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Eurofertil

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Without sharing the names of the participants, additional data can be shared upon request

IPD Sharing Time Frame

IPD will be available after the study is submitted to a journal. There is not a limitation for the duration of availability

IPD Sharing Access Criteria

The reviewers can be able access the IPD and supporting information. Requests by email will be acceptable for data rather than names of participants

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe