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

NCT06619379 | Active Not Recruiting

• 1 other identifier: Eurofertil
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy Rates

Keywords

IVF embryo transfer speculum retention

Outcome Measures

Primary Outcomes (1)

• Pregnacy rates

  Pregnancy rates is the primary outcome

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

Study Arms (2)

Plastic speculum

OTHER

Metal speculum

Other: Retention time of speculum

Metal speculum

OTHER

Metal speculum will be used in this group

Other: Retention time of speculum

Interventions

Retention time of speculum OTHER

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 just after the transfer catheter is withdrawn 2. 60 seconds after the transfer catheter is withdrawn 3. 420 second (7 minutes) after the catheter is withdrawn

Metal speculum; Plastic speculum

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: the participants are women whom embryo transfer will be performed
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Eurofertil IVF Health Center: lead

Study Sites (1)

Eurofertil

Bursa, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Embryologist

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: October 1, 2024
• Study Start: June 17, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be available after the study is submitted to a journal. There is not a limitation for the duration of availability
• 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

Locations

TU (1)