InfertilityNCT03345251
Physical Endometrial Manipulation and Its Effect on ICSI
A study testing Hydrotubation in people with Infertility, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility . Implantation is the main rate limiting step in IVF outcome. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Hydrotubation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 640 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2017to 28 Dec 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Infertile female age 20-35 years
- Previous Failed one ICSI trial
- normal basal hormonal profile [FSH, LH] 3-10 mIU/ml and 1.8-8.5 mIU/ml respectively, --normal endometrial cavity
- patent tubes
- normal Husband semen analysis
Who cannot join
- Ovarian factor of infertility
- Tubal factor of infertility
- Endometrial factor of infertility
- Male factor of infertility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physical Endometrial Manipulation and Its Effect on Success Rate in Patients With Previous ICSI Failure
Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility . Implantation is the main rate limiting step in IVF outcome. Implantation is described at cellular and molecular level by adhesion or fixation of good quality embryo to receptive endometrium within a critical period of time which is called the window of implantation .
Read the detailed description
Testing the effect of Physical manipulation of the endometrium on the quality of the endometrium prior to ICSI cycle and if it increases the success rate
- Conditions
- Infertility
- Being tested
- Hydrotubation
- Keywords
- ICSI - physical - Manipulation - scratching
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrotubationDevice
Also called Sonohysterography, Endometrial scratching
| Study group | Role | What they receive |
|---|---|---|
| manipulation of endometrium | Experimental | The arm is physical manipulation to the endometrium prior to ICSI By one of these interventions )Hydrotubation , Sonohysterography or endometrial scratching Receives: Device: Hydrotubation |
| no manipulation to endometrium in ICSI | Placebo comparator | This is the control group , with no manipulation to endometrium prior to ICSI No intervention to this group Receives: Device: Hydrotubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants who achieved clinical pregnancy
Describes how many participant will continue pregnancy after positive pregnancy test
Measured: 6 weeks after embryo transfer
Secondary outcomes (1)
The number of participants who achieved ongoing pregnancy and live birth
Describes who many participant will continue pregnancy till he had birth and a live birth
Measured: 9 months after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start3 Jan 2017
- Primary completion25 Dec 2017
- Study completion28 Dec 2017
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 640 were enrolled but 608 were analyzed
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- Mahmoud Alalfy, master, Study chair, Algazeerah hospital -Location (Giza -Egypt )
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345251
- Sponsor's protocol ID
- Algazeerah
- Status last verified
- Aug 2021
- First submitted
- 25 Oct 2017
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Endometrial Manipulation and Its Effect on Success Rate in Patients With Previous ICSI Failure
- ClinicalTrials.gov ID
- NCT03345251
- Acronym / sponsor ID
- Algazeerah
- Conditions
- Infertility
- Keywords
- ICSI - physical - Manipulation - scratching
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 25 Dec 2017 (actual)
- Study completion
- 28 Dec 2017 (actual)
- First posted
- 17 Nov 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.
Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility . Implantation is the main rate limiting step in IVF outcome. Implantation is described at cellular and molecular level by adhesion or fixation of good quality embryo to receptive endometrium within a critical period of time which is called the window of implantation .
Detailed description
Testing the effect of Physical manipulation of the endometrium on the quality of the endometrium prior to ICSI cycle and if it increases the success rate
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 640 were enrolled but 608 were analyzed
| Arm | Type | Receives |
|---|---|---|
| manipulation of endometrium | Experimental | Device: HydrotubationThe arm is physical manipulation to the endometrium prior to ICSI By one of these interventions )Hydrotubation , Sonohysterography or endometrial scratching |
| no manipulation to endometrium in ICSI | Placebo comparator | Device: HydrotubationThis is the control group , with no manipulation to endometrium prior to ICSI No intervention to this group |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Infertile female age 20-35 years
- Previous Failed one ICSI trial
- normal basal hormonal profile [FSH, LH] 3-10 mIU/ml and 1.8-8.5 mIU/ml respectively, --normal endometrial cavity
- patent tubes
- normal Husband semen analysis
Key exclusion criteria (4 listed)
- Ovarian factor of infertility
- Tubal factor of infertility
- Endometrial factor of infertility
- Male factor of infertility
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 |
|---|---|---|
| HydrotubationAlso: Sonohysterography, Endometrial scratching | Device | manipulation of endometrium, no manipulation to endometrium in ICSI |
Primary outcome
The number of participants who achieved clinical pregnancy
Time frame: 6 weeks after embryo transfer
Describes how many participant will continue pregnancy after positive pregnancy test
1 secondary outcome
The number of participants who achieved ongoing pregnancy and live birth
Time frame: 9 months after embryo transfer
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 2 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Infertility
RecruitingPhase 3
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
Infertility
Active, not recruitingObservational study
Fresh Versus Vitrified-Warmed Donor Oocytes: Embryological and Clinical Outcomes
Infertility, Donor Oocyte Assisted Reproduction
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
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.
Mahmoud Alalfy, master study chair
Algazeerah hospital -Location (Giza -Egypt )
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrotubation in people with Infertility, run by Aljazeera 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 5 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: finished, as of the sponsor's last update on 2 Sep 2021. 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. Some participants in this study may receive a placebo. 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?
The number of participants who achieved clinical pregnancy (time frame: 6 weeks after embryo transfer). 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 2 Sep 2021.