Comparison of the Effect of Cervical Mucus Cleaning Method Applied Before Embryo Transfer on Pregnancy Rates.

NCT04888091 | Completed

• 1 other identifier: 90-07.April.2021
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the impact of cervical mucus cleansing before embryo transfer and compare two different instruments for this purpose.

Conditions

Infertility

Keywords

Cervical mucus; Embryo transfer; Pregnancy rate

Outcome Measures

Primary Outcomes (2)

• Detecting pregnancy after embryo transfer.

  Confirmation of pregnancy with serum βhcg value at the earliest 12th day after embryo transfer.

  12 days after embryo transfer/ intervention.

• Confirmation of fetal cardiac activity in detected pregnancy.

  Evaluation of fetal cardiac activity on ultrasound.

  3-4 weeks after embryo transfer/ intervention.

Secondary Outcomes (1)

• Success of embryo transfer during intervention.

  5 minutes after embryo transfer.

Study Arms (3)

Cervical mucus removal with cotton swab

ACTIVE COMPARATOR

Cervical mucus will be removed with cotton swab before embryo transfer

Procedure: Cotton swab

Cervical mucus removal with cannula

ACTIVE COMPARATOR

Cervical mucus will be removed with cannula before embryo transfer

Procedure: Cannula

No cervical mucus removal

NO INTERVENTION

Cervical mucus will not be removed prior to embryo transfer

Interventions

Cotton swab PROCEDURE

Removal of the cervical mucus with a cotton swab before embryo transfer.

Cervical mucus removal with cotton swab

Cannula PROCEDURE

Removal of the cervical mucus with a cannula before embryo transfer.

Cervical mucus removal with cannula

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old women,
• Women undergoing good quality embryo transfer,
• Women who are eligible for a single or double embryo transfer.

You may not qualify if:

• If there is a diagnosis of a uterine anomaly,
• If there is a diagnosis of myoma uteri,
• If there is a diagnosis of rheumatological disease,
• Women to be transferred other than good quality embryo,
• Hİstory of previous pelvic, gynecological operation.

Sponsors & Collaborators

• Zeynep Kamil Maternity and Pediatric Research and Training Hospital: lead

Study Sites (1)

Zeynep Kamil Women and Children's Diseases Training and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Infertility

Interventions

Cannula

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• Belgin Devranoğlu, Ass. Prof.

  Zeynep Kamil Women and Children's Diseases Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• Müşerref Banu Yılmaz, Md.

  Zeynep Kamil Women and Children's Diseases Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant masking: Embryo transfer is done while the patient is lying in lithotomy position in accordance with gynecological examination. The patient is informed about the preparations before the embryo transfer and then the examination is completed. The patient will not be informed about the method used for removal of the cervical mucus. The patient's lying position also does not allow observation of the material used to remove cervical mucus.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Specialist in Obstetrics and Gynecology

Model Details: It is a parallel model interventional study. The sample size is calculated as 180 patients. Sixty patients will be assigned to each study arm by randomization. It is planned to use random computerized numbers for randomization. İn arm 1, cervical mucus will be removed with a cotton swab before embryo transfer. In arm 2, cervical mucus will be removed with a canula before embryo transfer. In arm 3, cervical mucus will not be removed.

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 17, 2021
• Study Start: June 25, 2021
• Primary Completion: July 8, 2022
• Study Completion: July 8, 2022
• Last Updated: February 23, 2024

Record last verified: 2024-02

Locations

TU (1)