InfertilityNCT01064219
Intrauterine Human Chorionic Gonadotrophins (hCG) and Endometrial Treg Cells
A study testing human chorionic gonadotrophin in people with Infertility, run by The Egyptian IVF-ET Center at 1 site in Egypt.
Trial summary
Intrauterine injection of hCG around the time of implantation may increase endometrial Treg cells and improve implantation. It has been demonstrated that regulatory T cells expand during pregnancy. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- human chorionic gonadotrophin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2010to Dec 2010
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Male factor infertility
- Ovulatory factor infertility
- Unexplained infertility
- Female age less than 39
Who cannot join
- Azoospermia
- Tubal factor infertility
- Pelvic endometriosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intrauterine Injection of Human Chorionic Gonadotrophins (hCG) on the Endometrial T-regulatory Cells and the Electronmicroscopic Endometrial Characteristics
Intrauterine injection of hCG around the time of implantation may increase endometrial Treg cells and improve implantation. It has been demonstrated that regulatory T cells expand during pregnancy. hCG was found to be secreted by the embryo immediately after fertilization and has chemoattractant properties to Treg cells.
Read the detailed description
Aim of the work:
To study the effect of intrauterine injection of human chorionic gonadotrophin on the endometrial T regulatory cells (Treg cells)and the electromicroscopic endometrial characteristics.
Background:
It has been demonstrated that regulatory T cells expand during pregnancy and are present at the feto-maternal interface at very early stages in pregnancy.
Rational:
Intrauterine injection of hCG around the time of implantation may increase endometrial Treg cells and improve implantation.
Methods:
Intrauterine injection of 100 IU hCG will be done followed by endometrial biopsy to check for Treg cells and pinopodes.
- Conditions
- Infertility
- Being tested
- human chorionic gonadotrophin
- Keywords
- hCG, Treg cells, implantation, pinopodes, endometrium
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human chorionic gonadotrophinDrug
Also called choriomon
intrauterine injection of 100 IU hCG followed by endometrial biopsy .
| Study group | Role | What they receive |
|---|---|---|
| intrauterine hCG | Experimental | intrauterine injection of 100 hCG followed by endometrial biopsy Receives: Drug: human chorionic gonadotrophin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the presence of Treg cells and pinopodes in the endometrium
Measured: 4 weeks
Secondary outcomes (1)
pregnancy rate
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionDec 2010
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Egyptian IVF-ET Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragaa Mansour, The Egyptian IVF-ET Center
- Investigators
- Ragaa Mansour, MD,PhD, Principal investigator, The Egyptian IVF-ET Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01064219
- Sponsor's protocol ID
- hCG and Treg cells
- Status last verified
- Dec 2010
- First submitted
- 5 Feb 2010
- Last updated
- 5 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intrauterine Injection of Human Chorionic Gonadotrophins (hCG) on the Endometrial T-regulatory Cells and the Electronmicroscopic Endometrial Characteristics
- ClinicalTrials.gov ID
- NCT01064219
- Acronym / sponsor ID
- hCG and Treg cells
- Conditions
- Infertility
- Keywords
- hCG, Treg cells, implantation, pinopodes, endometrium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Egyptian IVF-ET CenterUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Feb 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.
Intrauterine injection of hCG around the time of implantation may increase endometrial Treg cells and improve implantation. It has been demonstrated that regulatory T cells expand during pregnancy. hCG was found to be secreted by the embryo immediately after fertilization and has chemoattractant properties to Treg cells.
Detailed description
Aim of the work:
To study the effect of intrauterine injection of human chorionic gonadotrophin on the endometrial T regulatory cells (Treg cells)and the electromicroscopic endometrial characteristics.
Background:
It has been demonstrated that regulatory T cells expand during pregnancy and are present at the feto-maternal interface at very early stages in pregnancy.
Rational:
Intrauterine injection of hCG around the time of implantation may increase endometrial Treg cells and improve implantation.
Methods:
Intrauterine injection of 100 IU hCG will be done followed by endometrial biopsy to check for Treg cells and pinopodes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intrauterine hCG | Experimental | Drug: human chorionic gonadotrophinintrauterine injection of 100 hCG followed by endometrial biopsy |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male factor infertility
- Ovulatory factor infertility
- Unexplained infertility
- Female age less than 39
Key exclusion criteria (3 listed)
- Azoospermia
- Tubal factor infertility
- Pelvic endometriosis
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 |
|---|---|---|
| human chorionic gonadotrophinAlso: choriomonintrauterine injection of 100 IU hCG followed by endometrial biopsy . | Drug | intrauterine hCG |
Primary outcome
the presence of Treg cells and pinopodes in the endometrium
Time frame: 4 weeks
1 secondary outcome
pregnancy rate
Time frame: 4 weeks
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 5 Nov 2013.
- 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.
Ragaa Mansour, MD,PhD principal investigator
The Egyptian IVF-ET Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human chorionic gonadotrophin in people with Infertility, run by The Egyptian IVF-ET Center 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 4 inclusion and 3 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 5 Nov 2013. 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?
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 presence of Treg cells and pinopodes in the endometrium (time frame: 4 weeks). 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 5 Nov 2013.