InfertilityPhase 2/3NCT01156181
Effect of Cervical Discharge Removal During ET on Pregnancy Rate
A Phase 2/3 study testing Cervical discharge removal in people with Infertility, run by Royan Institute at 1 site in Iran.
Trial summary
Pregnancy rate may be affected by multiple factors such as embryo transfer techniques. Even small differences in embryo transfer methods may affect pregnancy rates. There is an inconsistency about the effect of the removal of cervical discharge on embryo transfer outcomes. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Cervical discharge removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 492 participants
- Where
- 1 siteIran
- Study dates
- May 2009to May 2010
- Phase
- Phase 2/3
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who were candidate for fresh embryo transfer during IVF/ICSI cycles were eligible for this study if they had two or more good quality embryos and age fewer than 40
Who cannot join
- The patients with frozen-thawed embryo transfer cycle
- Those with oocyte donation cycle
- The women with uterine abnormality
- The women with submucosal and intramural myoma
- Who does not have good-quality embryos appropriate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Cervical Discharge Removal Before Embryo Transfer on ICSI Cycle Outcomes
Pregnancy rate may be affected by multiple factors such as embryo transfer techniques. Even small differences in embryo transfer methods may affect pregnancy rates. There is an inconsistency about the effect of the removal of cervical discharge on embryo transfer outcomes. Some studies showed that cervical mucus removal before embryo transfer can increase pregnancy rate, however the others could not find any significant effect about the removal of cervical mucus on pregnancy or live birth rates. Given to the conflicting evidences, our study aimed to determine whether the cervical discharge removal has positive effect on pregnancy rate.
Read the detailed description
492 Infertile women who were candidate for fresh embryo transfer during IVF/ICSI cycles were eligible for this study if they had two or more good quality embryos. All categories of female or male factors infertility except uterine factor infertility were eligible for participation in the study. Immediately prior to embryo transfer, women were randomly allocated to either treatment (cleaning the cervical canal) or control groups. In treatment group, excess mucus and debris were cleared from the cervical canal using a sterile cotton swabs. The cervical discharge was scored as mucosal, bloody, combination of mucosal and bloody, or infected. Control group had no cervical cleaning before embryo transfer. Then, the embryos were loaded into the transfer catheter by the embryologist and were deposited into the uterine cavity by one experience physician. The primary endpoint was clinical pregnancy. Fertilization, Implantation, abortion, and live birth rates were the other outcomes of interest or secondary outcomes.
- Conditions
- Infertility
- Being tested
- Cervical discharge removal, control
- Keywords
- Cervical mucus, Embryo transfer, ICSI cycle, Pregnancy rate
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical discharge removalProcedure or surgery
Cervical discharge will be removed using a cotton swab before embryo transfer during ICSI cycles
controlProcedure or surgery
Embryo transfer without any intervention
| Study group | Role | What they receive |
|---|---|---|
| Cervical discharge removal | Experimental | Cervical discharge will be removed using a cotton swab before embryo transfer during ICSI cycles Receives: Procedure: Cervical discharge removal |
| Control | Active comparator | Embryo transfer without any intervention Receives: Procedure: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Measured: 9 months after recruiting
Secondary outcomes (4)
Fertilization rate
Measured: 2 weeks
Implantation rate
Measured: 1 month
Miscarriage rate
Measured: 9 months
Live birth rate
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startMay 2009
- Primary completionMay 2010
- Study completionMay 2010
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 InfertilityStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 492 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ashraf Moini Moini, MD, Study chair, Academic staff of Endocrinology and Female Infertility Department, Royan Institute, Tehran - IranLadan Mohammadi yeganeh, MSc, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156181
- Sponsor's protocol ID
- Royan-Emb-007
- Status last verified
- Jul 2010
- First submitted
- 1 Jul 2010
- Last updated
- 21 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moini A, Kiani K, Bahmanabadi A, Akhoond M, Akhlaghi A. Improvement in pregnancy rate by removal of cervical discharge prior to embryo transfer in ICSI cycles: a randomised clinical trial. Aust N Z J Obstet Gynaecol. 2011 Aug;51(4):315-20. doi: 10.1111/j.1479-828X.2011.01318.x. Epub 2011 Jun 9.
PubMed 21806579
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cervical Discharge Removal Before Embryo Transfer on ICSI Cycle Outcomes
- ClinicalTrials.gov ID
- NCT01156181
- Acronym / sponsor ID
- Royan-Emb-007
- Conditions
- Infertility
- Keywords
- Cervical mucus, Embryo transfer, ICSI cycle, Pregnancy rate
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 492 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- May 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 2 Jul 2010 (estimated)
- 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.
Pregnancy rate may be affected by multiple factors such as embryo transfer techniques. Even small differences in embryo transfer methods may affect pregnancy rates. There is an inconsistency about the effect of the removal of cervical discharge on embryo transfer outcomes. Some studies showed that cervical mucus removal before embryo transfer can increase pregnancy rate, however the others could not find any significant effect about the removal of cervical mucus on pregnancy or live birth rates. Given to the conflicting evidences, our study aimed to determine whether the cervical discharge removal has positive effect on pregnancy rate.
Detailed description
492 Infertile women who were candidate for fresh embryo transfer during IVF/ICSI cycles were eligible for this study if they had two or more good quality embryos. All categories of female or male factors infertility except uterine factor infertility were eligible for participation in the study. Immediately prior to embryo transfer, women were randomly allocated to either treatment (cleaning the cervical canal) or control groups. In treatment group, excess mucus and debris were cleared from the cervical canal using a sterile cotton swabs. The cervical discharge was scored as mucosal, bloody, combination of mucosal and bloody, or infected. Control group had no cervical cleaning before embryo transfer. Then, the embryos were loaded into the transfer catheter by the embryologist and were deposited into the uterine cavity by one experience physician. The primary endpoint was clinical pregnancy. Fertilization, Implantation, abortion, and live birth rates were the other outcomes of interest or secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervical discharge removal | Experimental | Procedure: Cervical discharge removalCervical discharge will be removed using a cotton swab before embryo transfer during ICSI cycles |
| Control | Active comparator | Procedure: controlEmbryo transfer without any intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women who were candidate for fresh embryo transfer during IVF/ICSI cycles were eligible for this study if they had two or more good quality embryos and age fewer than 40
Key exclusion criteria (5 listed)
- The patients with frozen-thawed embryo transfer cycle
- Those with oocyte donation cycle
- The women with uterine abnormality
- The women with submucosal and intramural myoma
- Who does not have good-quality embryos appropriate
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 |
|---|---|---|
| Cervical discharge removalCervical discharge will be removed using a cotton swab before embryo transfer during ICSI cycles | Procedure or surgery | Cervical discharge removal |
| controlEmbryo transfer without any intervention | Procedure or surgery | Control |
Primary outcome
Pregnancy rate
Time frame: 9 months after recruiting
4 secondary outcomes
Fertilization rate
Time frame: 2 weeks
Implantation rate
Time frame: 1 month
Miscarriage rate
Time frame: 9 months
Live birth rate
Time frame: 9 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 21 Sep 2011.
- Derived from this study: PubMed 21806579Moini A, Kiani K, Bahmanabadi A, Akhoond M, Akhlaghi A. Improvement in pregnancy rate by removal of cervical discharge prior to embryo transfer in ICSI cycles: a randomised clinical trial. Aust N Z J Obstet Gynaecol. 2011 Aug;51(4):315-20. doi: 10.1111/j.1479-828X.2011.01318.x. Epub 2011 Jun 9.
- Related InfoLink provided by the sponsor.
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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.
Ashraf Moini Moini, MD study chair
Academic staff of Endocrinology and Female Infertility Department, Royan Institute, Tehran - Iran
Ladan Mohammadi yeganeh, MSc principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cervical discharge removal in people with Infertility, run by Royan Institute at 1 site in Iran.
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 5 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 21 Sep 2011. 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 Iran. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pregnancy rate (time frame: 9 months after recruiting). 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 NCT01156181, 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 21 Sep 2011.