InfertilityNCT02245750
Value of Routine Hysteroscopy Prior to IVF/ICSI Cycles
A study testing Hysteroscopy in people with Infertility, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
In the current study the investigators hypothesize that Routine Hysteroscopy prior to IVF/ICSI cycle increases the clinical pregnancy rate. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Hysteroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2014to Feb 2015
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Patient's age ranged from 20-40 years.
- Normal appearance of the uterine cavity on hysterosalpingography.
- Patients prepared for IVF/ICSI cycle.
Who cannot join
- Patients who have any contraindications for hysteroscopy. (Menstruation, pregnancy, severe vaginitis or cervicitis, endometrial infection and history of Pelvic Inflammatory Diseases).
- Patients with uterine cavity pathology previously known to the examiner.
- Patients with previous uterine surgery such as myomectomy.
- Patients with abnormal HSG.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams Maternity hospital
Cairo
mostafa F gomaa, MD
About this study
In the current study the investigators hypothesize that Routine Hysteroscopy prior to IVF/ICSI cycle increases the clinical pregnancy rate.
Read the detailed description
A randomized controlled study involving 300 patients with recurrent implantation failure
- Conditions
- Infertility
- Being tested
- Hysteroscopy
- Keywords
- hysteroscopy - recurrent implantation failure
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysteroscopyDevice
hysteroscopy and endometrial injury prior to the IVF/ICSI cycle
| Study group | Role | What they receive |
|---|---|---|
| Routine Invistigations | No intervention | ICSI with long luteal phase protocol |
| Hysteroscopy | Experimental | hysteroscopy will be done prior to the ICSI cycle Receives: Device: Hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Clinical pregnancy rate.
Measured: 6 months
Secondary outcomes (1)
• Live Birth Rate
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 posted22 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2014 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mostafa fouad, Ain Shams Maternity Hospital
- Investigators
- mostafa f gomaa, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245750
- Sponsor's protocol ID
- Routine Hysterscopy
- Status last verified
- Sep 2014
- First submitted
- 24 Apr 2014
- Last updated
- 22 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Routine Hysteroscopy Prior to IVF/ICSI Cycles
- ClinicalTrials.gov ID
- NCT02245750
- Acronym / sponsor ID
- Routine Hysterscopy
- Conditions
- Infertility
- Keywords
- hysteroscopy - recurrent implantation failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 22 Sep 2014 (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.
In the current study the investigators hypothesize that Routine Hysteroscopy prior to IVF/ICSI cycle increases the clinical pregnancy rate.
Detailed description
A randomized controlled study involving 300 patients with recurrent implantation failure
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Invistigations | No intervention | –ICSI with long luteal phase protocol |
| Hysteroscopy | Experimental | Device: Hysteroscopyhysteroscopy will be done prior to the ICSI cycle |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patient's age ranged from 20-40 years.
- Normal appearance of the uterine cavity on hysterosalpingography.
- Patients prepared for IVF/ICSI cycle.
Key exclusion criteria (4 listed)
- Patients who have any contraindications for hysteroscopy. (Menstruation, pregnancy, severe vaginitis or cervicitis, endometrial infection and history of Pelvic Inflammatory Diseases).
- Patients with uterine cavity pathology previously known to the examiner.
- Patients with previous uterine surgery such as myomectomy.
- Patients with abnormal HSG.
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 |
|---|---|---|
| Hysteroscopyhysteroscopy and endometrial injury prior to the IVF/ICSI cycle | Device | Hysteroscopy |
Primary outcome
• Clinical pregnancy rate.
Time frame: 6 months
1 secondary outcome
• Live Birth Rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2014.
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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.
mostafa f gomaa, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopy in people with Infertility, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Sep 2014. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Mohammed, MbbcH (00201110362860, ahmadmarzok85@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Clinical pregnancy rate. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2014.