InfertilityPhase 4NCT02329197
Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer in Women With Previous IVF Failure
A Phase 4 study testing Human Chorionic Gonadotropin (HCG) in people with Infertility and Invitro Fertilization, run by Mansoura University at 1 site in Egypt.
Trial summary
Women with history of previous IVF cycle failure will be subjected to a fresh IVF cycle. At the time they will be undergoing embryo transfer, 50 IU of human chorionic gonadotropins diluted in 0.025ml of tissue culture media will be injected intrauterine by embryo transfer catheter 10 minutes before embryo transfer… Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Infertility, Invitro Fertilization
- What is being tested?
- Human Chorionic Gonadotropin (HCG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2014to Mar 2016
- 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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with previous IVF failure undergoing fresh IVF cycle
Who cannot join
- women with hydrosalpinges women with intrauterine lesion like submucous fibroid or polyps
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Teaching Hospital
Al Mansurah, 53111
Ahmed Gibreel, MD
About this study
Women with history of previous IVF cycle failure will be subjected to a fresh IVF cycle. At the time they will be undergoing embryo transfer, 50 IU of human chorionic gonadotropins diluted in 0.025ml of tissue culture media will be injected intrauterine by embryo transfer catheter 10 minutes before embryo transfer procedure.
Read the detailed description
Infertile women with history of previous IVF cycle failure will be subjected top a fresh IVF cycle. Following controlled ovarian hyperstimulation, ovum pick up and at the time they will be undergoing embryo transfer, 50 IU of human chorionic gonadotropins diluted in 0.025ml of tissue culture media will be injected intrauterine by embryo transfer catheter 10 minutes before embryo transfer procedure.
- Conditions
- Infertility, Invitro Fertilization
- Being tested
- Human Chorionic Gonadotropin (HCG)
- Keywords
- Infertility, Invitro fertilization
- 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 Gonadotropin (HCG)Drug
Also called u-hCG
intrauterine injection of HCG prior to embryo transfer in an IVF cycle
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | women undergoing IVF treatment will be subjected for intrauterine injection of 10 IU of human chorionic gonadotropin (HCG) (diluted in 0.025ml of tissue culture), 10 minutes before embryo transfer procedure. Receives: Drug: Human Chorionic Gonadotropin (HCG) |
| Group B | No intervention | women undergoing IVF treatment will embryo transfer procedure performed in the standard way without intrauterine injection of HCG. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth
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 posted31 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015 (estimated)
- Study completionMar 2016 (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.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gibreel, Mansoura University
- Investigators
- Ahmed Gibreel, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329197
- Sponsor's protocol ID
- H005
- Status last verified
- Dec 2014
- First submitted
- 26 Dec 2014
- Last updated
- 31 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Injection of Human Chorionic Gonadotropin Before Embryo Transfer in Women With Previous IVF Failure
- ClinicalTrials.gov ID
- NCT02329197
- Acronym / sponsor ID
- H005
- Conditions
- Infertility, Invitro Fertilization
- Keywords
- Infertility, Invitro fertilization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 31 Dec 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.
Women with history of previous IVF cycle failure will be subjected to a fresh IVF cycle. At the time they will be undergoing embryo transfer, 50 IU of human chorionic gonadotropins diluted in 0.025ml of tissue culture media will be injected intrauterine by embryo transfer catheter 10 minutes before embryo transfer procedure.
Detailed description
Infertile women with history of previous IVF cycle failure will be subjected top a fresh IVF cycle. Following controlled ovarian hyperstimulation, ovum pick up and at the time they will be undergoing embryo transfer, 50 IU of human chorionic gonadotropins diluted in 0.025ml of tissue culture media will be injected intrauterine by embryo transfer catheter 10 minutes before embryo transfer procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Human Chorionic Gonadotropin (HCG)women undergoing IVF treatment will be subjected for intrauterine injection of 10 IU of human chorionic gonadotropin (HCG) (diluted in 0.025ml of tissue culture), 10 minutes before embryo transfer procedure. |
| Group B | No intervention | –women undergoing IVF treatment will embryo transfer procedure performed in the standard way without intrauterine injection of HCG. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with previous IVF failure undergoing fresh IVF cycle
Key exclusion criteria (1 listed)
- women with hydrosalpinges women with intrauterine lesion like submucous fibroid or polyps
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 Gonadotropin (HCG)Also: u-hCGintrauterine injection of HCG prior to embryo transfer in an IVF cycle | Drug | Group A |
Primary outcome
Live Birth
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 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.
Ahmed Gibreel, MD principal investigator
Mansoura University
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 Gonadotropin (HCG) in people with Infertility and Invitro Fertilization, run by Mansoura University 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 1 inclusion and 1 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 31 Dec 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Gibreel, MD (002/01004045733, ahmedfathgi@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live Birth (time frame: 9 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 31 Dec 2014.