InfertilityPhase 4NCT01030393
Intra-uterine Injection of Human Chorionic Gonadotrophin (hCG) Before Embryo Transfer
A Phase 4 study testing human chorionic gonadotrophin in people with Infertility, run by The Egyptian IVF-ET Center at 1 site in Egypt.
Trial summary
Chorionic gonadotrophins (hCG) play an important role in implantation. The aim of the study is to evaluate the effect of intrauterine injection of hCG before embryo transfer in IVF/ICSI on the implantation and pregnancy rates. Read more about this study
- Who is it for?
- Ages 20 to 39 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
- 472 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2010to Feb 2011
- Phase
- Phase 4
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- male factor infertility
- normal female hormonal profile
- normal uterine cavity
Who cannot join
- previous ICSI failure
- endometriosis
- azoospermia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-uterine Injection of Human Chorionic Gonadotrophin Before Embryo Transfer in ICSI
Chorionic gonadotrophins (hCG) play an important role in implantation. The aim of the study is to evaluate the effect of intrauterine injection of hCG before embryo transfer in IVF/ICSI on the implantation and pregnancy rates. The rational is that intrauterine hCG injection will attract regulatory T cells and improve implantation.
Read the detailed description
Background :
Human chorionic gonadotrophin ( hCG) was found to secreted immediately after fertilization by the embryo. It plays an important role in implantation and in attracting regulatory T cells to the endometrium.
Rational :
Intrauterine injection of hCG before embryo transfer in IVF/ICSI may increase endometrial regulatory T cells ( Treg ) and improve the implantation and pregnancy rates.
Aim of the work :
To study the effect of intrauterine injection of hCG before embryo transfer on the implantation and pregnancy rates after IVF/ICSI.
Subjects :
Infertile patients undergoing ICSI.
Inclusion criteria :
- Female age less than 40 years
- Male factor infertility
- Normal female hormonal profile and uterine cavity
Exclusion criteria :
- Previous ICSI failure
- Azoospermia
- Endometriosis
Study group: Intrauterine injection of 100 iu of hCG (group 1)or 200 iu of hCG ( group 2) will be done during the dummy embryo transfer which is done 10-15 minutes before the actual embryo transfer.
Control group: The embryo transfer will be done without prior intrauterine injection of hCG
Main outcome measures :
Implantation and pregnancy rates
Secondary outcome measures :
miscarriage and delivery rates
- Conditions
- Infertility
- Being tested
- human chorionic gonadotrophin
- Keywords
- hCG, pregnancy, implantation, ICSI, IVF
- 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 (group1) or 200 iu (group2) of hCG before embryo transfer in IVF/ICSI And intrauterine injection of 500 iu hCG before embryo transfer .
| Study group | Role | What they receive |
|---|---|---|
| intrauterine hCG | Experimental | Experimental arm : intrauterine injection of 100 iu(group1)or 200 iu (group2) of hCG before embryo transfer.
Intrauterine injection of 500 iu hCG before embryo transfer Receives: Drug: human chorionic gonadotrophin |
What is being measured
The primary outcome is the main question the study is designed to answer.
implantation and pregnancy rates
Measured: 5 weeks after embryo transfer
Secondary outcomes (1)
miscarriage and delivery rates
Measured: 9 months from embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 472 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 T Mansour, MD,PhD, Principal investigator, The Egyptian IVF-ET Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030393
- Sponsor's protocol ID
- hCG 100
- Status last verified
- Aug 2012
- First submitted
- 10 Dec 2009
- Last updated
- 21 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schumacher A, Brachwitz N, Sohr S, Engeland K, Langwisch S, Dolaptchieva M, Alexander T, Taran A, Malfertheiner SF, Costa SD, Zimmermann G, Nitschke C, Volk HD, Alexander H, Gunzer M, Zenclussen AC. Human chorionic gonadotropin attracts regulatory T cells into the fetal-maternal interface during early human pregnancy. J Immunol. 2009 May 1;182(9):5488-97. doi: 10.4049/jimmunol.0803177.
PubMed 19380797Mansour R, Tawab N, Kamal O, El-Faissal Y, Serour A, Aboulghar M, Serour G. Intrauterine injection of human chorionic gonadotropin before embryo transfer significantly improves the implantation and pregnancy rates in in vitro fertilization/intracytoplasmic sperm injection: a prospective randomized study. Fertil Steril. 2011 Dec;96(6):1370-1374.e1. doi: 10.1016/j.fertnstert.2011.09.044. Epub 2011 Nov 1.
PubMed 22047664
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-uterine Injection of Human Chorionic Gonadotrophin Before Embryo Transfer in ICSI
- ClinicalTrials.gov ID
- NCT01030393
- Acronym / sponsor ID
- hCG 100
- Conditions
- Infertility
- Keywords
- hCG, pregnancy, implantation, ICSI, IVF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- The Egyptian IVF-ET CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Dec 2009 (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.
Chorionic gonadotrophins (hCG) play an important role in implantation. The aim of the study is to evaluate the effect of intrauterine injection of hCG before embryo transfer in IVF/ICSI on the implantation and pregnancy rates. The rational is that intrauterine hCG injection will attract regulatory T cells and improve implantation.
Detailed description
Background :
Human chorionic gonadotrophin ( hCG) was found to secreted immediately after fertilization by the embryo. It plays an important role in implantation and in attracting regulatory T cells to the endometrium.
Rational :
Intrauterine injection of hCG before embryo transfer in IVF/ICSI may increase endometrial regulatory T cells ( Treg ) and improve the implantation and pregnancy rates.
Aim of the work :
To study the effect of intrauterine injection of hCG before embryo transfer on the implantation and pregnancy rates after IVF/ICSI.
Subjects :
Infertile patients undergoing ICSI.
Inclusion criteria :
- Female age less than 40 years
- Male factor infertility
- Normal female hormonal profile and uterine cavity
Exclusion criteria :
- Previous ICSI failure
- Azoospermia
- Endometriosis
Study group: Intrauterine injection of 100 iu of hCG (group 1)or 200 iu of hCG ( group 2) will be done during the dummy embryo transfer which is done 10-15 minutes before the actual embryo transfer.
Control group: The embryo transfer will be done without prior intrauterine injection of hCG
Main outcome measures :
Implantation and pregnancy rates
Secondary outcome measures :
miscarriage and delivery rates
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intrauterine hCG | Experimental | Drug: human chorionic gonadotrophinExperimental arm : intrauterine injection of 100 iu(group1)or 200 iu (group2) of hCG before embryo transfer. Intrauterine injection of 500 iu hCG before embryo transfer |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male factor infertility
- normal female hormonal profile
- normal uterine cavity
Key exclusion criteria (3 listed)
- previous ICSI failure
- endometriosis
- azoospermia
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 (group1) or 200 iu (group2) of hCG before embryo transfer in IVF/ICSI And intrauterine injection of 500 iu hCG before embryo transfer . | Drug | intrauterine hCG |
Primary outcome
implantation and pregnancy rates
Time frame: 5 weeks after embryo transfer
1 secondary outcome
miscarriage and delivery rates
Time frame: 9 months from 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 21 Aug 2012.
- Background: PubMed 19380797Schumacher A, Brachwitz N, Sohr S, Engeland K, Langwisch S, Dolaptchieva M, Alexander T, Taran A, Malfertheiner SF, Costa SD, Zimmermann G, Nitschke C, Volk HD, Alexander H, Gunzer M, Zenclussen AC. Human chorionic gonadotropin attracts regulatory T cells into the fetal-maternal interface during early human pregnancy. J Immunol. 2009 May 1;182(9):5488-97. doi: 10.4049/jimmunol.0803177.
- Derived from this study: PubMed 22047664Mansour R, Tawab N, Kamal O, El-Faissal Y, Serour A, Aboulghar M, Serour G. Intrauterine injection of human chorionic gonadotropin before embryo transfer significantly improves the implantation and pregnancy rates in in vitro fertilization/intracytoplasmic sperm injection: a prospective randomized study. Fertil Steril. 2011 Dec;96(6):1370-1374.e1. doi: 10.1016/j.fertnstert.2011.09.044. Epub 2011 Nov 1.
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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 T 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 Phase 4 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 3 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 21 Aug 2012. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
implantation and pregnancy rates (time frame: 5 weeks after embryo transfer). 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 NCT01030393, which also lists 2 linked publications.
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 Aug 2012.