EmbryoNCT03097042
Comparison of Two Different Catheter Withdrawal Technique
A study testing Embryo transfer any further manipulation and Embryo transfer with catheter Manipulation in people with Embryo and Catheter Site Discharge, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
The embryologist will oad the embryos into the catheter at the right position, then the catheter will be slowly pushed through the cervical canal, 1-2 cm beneath the fundus 5.5 cm away from the cervical external os.The embryos will be delivered by pushing the plunger of the syringe from the mid-cavitary positioned… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Embryo, Catheter Site Discharge
- What is being tested?
- Embryo transfer any further manipulation and Embryo transfer with catheter Manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers between the ages 20 to 40 Good quality embryo transfer Easy embryo transfer (use of soft catheter, not using tenaculum), Fresh cycle Single embryo transfer
Who cannot join
- Volunteers younger than 20 and older than 40 years old Volunteers with poor ovarian reserve Low quality embryos Difficult embryo transfer (use of rigid catheter, use of tenaculum, passing of outer catheters heath from cervical os) Frozen cycle Volunteers that receive another transfer of embryos that remain in the catheter after the initial transfer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Different Catheter Withdrawal Technique During Embryo Transfer
The embryologist will oad the embryos into the catheter at the right position, then the catheter will be slowly pushed through the cervical canal, 1-2 cm beneath the fundus 5.5 cm away from the cervical external os.The embryos will be delivered by pushing the plunger of the syringe from the mid-cavitary positioned catheter and keeping the plunger pushed down.
Study Group: The catheter will be pulled back slowly and without rotation with the plunger still pushed forward.
Control Group: The catheter will be pulled back slowly with a 360°rotation with the plunger kept pushed forward.
Read the detailed description
Patients to be included will be those meeting the study criteria who present at Istanbul Zeynep Kamil Training and Research Hospital, In vitro fertilization unit between February 1, 2017 and August, 2017.
The voluntary participants of the study will undergo controlled ovarian stimulation that is routinely performed in our clinic, followed by ovum pick up (OPU) and embryo transfer procedure. Volunteers will be asked to hold the urine 2 hours before the procedure to ensure fullness of the bladder. Identification details will be checked to verify that the names on the embryo containers are correct. The embryos will be examined by the embryologist. The participants will be informed before the procedure about the fertilization rates, number and quality of the developed embryos, the number of embryos to be transferred and the number of embryos planned to be frozen. Patients will undergo the procedure in the lithotomy position.The fullness of the bladder will be verified by inserting a speculum cervix and the vagina will be cleaned with a sterile serum physiological saline solution (SF) sponge, and cervical mucus aspired from the external os gently with a special soft aspirator catheter.
After the cervix is cleaned with culture liquid, a trial transfer will be performed with a sterile catheter. At this stage, only the soft internal catheter will pass through the internal os and the outer sheath will be stopped when it reaches the internal os. The outer sheath of the catheter will be advanced 2 cm into the cervical canal under ultrasound guidance and will be stopped before passing the internal os. Once it is ensured that the soft catheter is inside the endometrial cavity, the embryologist will be informed of the appropriate catheter position. Embryologist will oad the embryos into the catheter at the right position, then the catheter will be slowly pushed through the cervical canal, 1-2 cm beneath the fundus 5.5 cm away from the cervical external os. The embryos will be delivered by pushing the plunger of the syringe from the mid-cavitary positioned catheter and keeping the plunger pushed down. Afterwards, the volunteers will be randomly divided into two groups. Randomization will be ensured by a computer-based programme.
- 1st Group Volunteers: The catheter will be pulled back slowly and without rotation with the plunger still pushed forward.
- 2nd GroupVolunteers:The catheter will be pulled back slowly with a 360° rotation with the plunger kept pushed forward. The speculum will remain in the cervix until the embryologist checks the catheter for the presence of any embryos, blood or mucus.
Parameters to be Reviewed: Age, weight, height of the participants, primary/secondary infertility, infertility duration, presence of additional diseases, gravida, parity, abortion history, endometrial thickness on the day of HCG, infertility reasons, baseline and total gonadotropin dose, stimulation period, number of collected oocytes, number of M2 oocytes, quality of transferred embryos, BhCG positivity
- Conditions
- Embryo, Catheter Site Discharge
- Being tested
- Embryo transfer any further manipulation, Embryo transfer with catheter Manipulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embryo transfer any further manipulationProcedure or surgery
The catheter will be pulled back slowly and without rotation with the plunger still pushed forward
Embryo transfer with catheter ManipulationProcedure or surgery
catheter rotation during withdrawal
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | The catheter will be pulled back slowly and without rotation Receives: Procedure: Embryo transfer with catheter Manipulation |
| Control Group | Active comparator | The catheter will be pulled back by rotating 360 degrees round itself Receives: Procedure: Embryo transfer any further manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy
Detection of the fetal heart rate by ultrasonography
Measured: 6 months
Secondary outcomes (1)
mucus or blood stained catheter
The rates of mucus and/or blood stained catheter will be calculated
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start1 Feb 2017
- Primary completion1 Aug 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmbryoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiğdem Yayla Abide, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097042
- Sponsor's protocol ID
- 180/2016
- Status last verified
- Jan 2018
- First submitted
- 24 Jan 2017
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yayla Abide C, Ozkaya E, Sanverdi I, Bostanci Ergen E, Kurek Eken M, Devranoglu B, Bilgic BE, Kilicci C, Kayatas Eser S. Prospective Randomized Trial Comparing Embryo Transfers of Cases with and without Catheter Rotation during Its Withdrawal. Gynecol Obstet Invest. 2018;83(4):397-403. doi: 10.1159/000489493. Epub 2018 May 14.
PubMed 29758560
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Catheter Withdrawal Technique During Embryo Transfer
- ClinicalTrials.gov ID
- NCT03097042
- Acronym / sponsor ID
- 180/2016
- Conditions
- Embryo, Catheter Site Discharge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The embryologist will oad the embryos into the catheter at the right position, then the catheter will be slowly pushed through the cervical canal, 1-2 cm beneath the fundus 5.5 cm away from the cervical external os.The embryos will be delivered by pushing the plunger of the syringe from the mid-cavitary positioned catheter and keeping the plunger pushed down.
Study Group: The catheter will be pulled back slowly and without rotation with the plunger still pushed forward.
Control Group: The catheter will be pulled back slowly with a 360°rotation with the plunger kept pushed forward.
Detailed description
Patients to be included will be those meeting the study criteria who present at Istanbul Zeynep Kamil Training and Research Hospital, In vitro fertilization unit between February 1, 2017 and August, 2017.
The voluntary participants of the study will undergo controlled ovarian stimulation that is routinely performed in our clinic, followed by ovum pick up (OPU) and embryo transfer procedure. Volunteers will be asked to hold the urine 2 hours before the procedure to ensure fullness of the bladder. Identification details will be checked to verify that the names on the embryo containers are correct. The embryos will be examined by the embryologist. The participants will be informed before the procedure about the fertilization rates, number and quality of the developed embryos, the number of embryos to be transferred and the number of embryos planned to be frozen. Patients will undergo the procedure in the lithotomy position.The fullness of the bladder will be verified by inserting a speculum cervix and the vagina will be cleaned with a sterile serum physiological saline solution (SF) sponge, and cervical mucus aspired from the external os gently with a special soft aspirator catheter.
After the cervix is cleaned with culture liquid, a trial transfer will be performed with a sterile catheter. At this stage, only the soft internal catheter will pass through the internal os and the outer sheath will be stopped when it reaches the internal os. The outer sheath of the catheter will be advanced 2 cm into the cervical canal under ultrasound guidance and will be stopped before passing the internal os. Once it is ensured that the soft catheter is inside the endometrial cavity, the embryologist will be informed of the appropriate catheter position. Embryologist will oad the embryos into the catheter at the right position, then the catheter will be slowly pushed through the cervical canal, 1-2 cm beneath the fundus 5.5 cm away from the cervical external os. The embryos will be delivered by pushing the plunger of the syringe from the mid-cavitary positioned catheter and keeping the plunger pushed down. Afterwards, the volunteers will be randomly divided into two groups. Randomization will be ensured by a computer-based programme.
- 1st Group Volunteers: The catheter will be pulled back slowly and without rotation with the plunger still pushed forward.
- 2nd GroupVolunteers:The catheter will be pulled back slowly with a 360° rotation with the plunger kept pushed forward. The speculum will remain in the cervix until the embryologist checks the catheter for the presence of any embryos, blood or mucus.
Parameters to be Reviewed: Age, weight, height of the participants, primary/secondary infertility, infertility duration, presence of additional diseases, gravida, parity, abortion history, endometrial thickness on the day of HCG, infertility reasons, baseline and total gonadotropin dose, stimulation period, number of collected oocytes, number of M2 oocytes, quality of transferred embryos, BhCG positivity
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Procedure: Embryo transfer with catheter ManipulationThe catheter will be pulled back slowly and without rotation |
| Control Group | Active comparator | Procedure: Embryo transfer any further manipulationThe catheter will be pulled back by rotating 360 degrees round itself |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Volunteers between the ages 20 to 40 Good quality embryo transfer Easy embryo transfer (use of soft catheter, not using tenaculum), Fresh cycle Single embryo transfer
Key exclusion criteria (1 listed)
- Volunteers younger than 20 and older than 40 years old Volunteers with poor ovarian reserve Low quality embryos Difficult embryo transfer (use of rigid catheter, use of tenaculum, passing of outer catheters heath from cervical os) Frozen cycle Volunteers that receive another transfer of embryos that remain in the catheter after the initial transfer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Embryo transfer any further manipulationThe catheter will be pulled back slowly and without rotation with the plunger still pushed forward | Procedure or surgery | Control Group |
| Embryo transfer with catheter Manipulationcatheter rotation during withdrawal | Procedure or surgery | Study group |
Primary outcome
Clinical Pregnancy
Time frame: 6 months
Detection of the fetal heart rate by ultrasonography
1 secondary outcome
mucus or blood stained catheter
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Derived from this study: PubMed 29758560Yayla Abide C, Ozkaya E, Sanverdi I, Bostanci Ergen E, Kurek Eken M, Devranoglu B, Bilgic BE, Kilicci C, Kayatas Eser S. Prospective Randomized Trial Comparing Embryo Transfers of Cases with and without Catheter Rotation during Its Withdrawal. Gynecol Obstet Invest. 2018;83(4):397-403. doi: 10.1159/000489493. Epub 2018 May 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Embryo transfer any further manipulation and Embryo transfer with catheter Manipulation in people with Embryo and Catheter Site Discharge, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Pregnancy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03097042, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.