InfertilityPhase 4NCT02330705
Timing of HCG Administration in IUI Cycles
A Phase 4 study testing HCG in people with Infertility, run by Mohamed Ibrahem Eid at 2 sites in Egypt.
Trial summary
Evaluation of the effect of altering the timing of human chorionic gonadotropin (HCG) administration on the clinical pregnancy rate in intrauterine insemination (IUI) cycles. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- HCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 2 sitesEgypt
- Study dates
- Jan 2015to Aug 2019
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Mild male factor infertility or unexplained infertility.
Who cannot join
- Advanced male factor infertility.
- Polycystic ovary syndrome (PCOS) as defined by the Rotterdam criteria.
- Endometriosis.
- Tubal disease.
- Uterine abnormalities or myoma.
- Previous uterine surgery.
- Metabolic or hormonal abnormalities.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Fertility care unit (FCU) in Mansoura University Hospitals
Al Mansurah, Dakahlia Governorate, 35111
Mohamed I Eid, Dr, +201225401274, dr_moh_eid@yahoo.com
- Recruiting
Private fertility care centers
Al Mansurah, Dakahlia Governorate
About this study
Official title: Timing of Human Chorionic Gonadotropin Administration in Intrauterine Insemination Cycles
Evaluation of the effect of altering the timing of human chorionic gonadotropin (HCG) administration on the clinical pregnancy rate in intrauterine insemination (IUI) cycles.
Read the detailed description
Women will be randomly divided into 3 groups; the first group will undergo IUI at the time HCG administration, the second group will undergo IUI 12 hours after HCG administration and the third group will undergo IUI 34-36 hours after HCG administration.
- Conditions
- Infertility
- Being tested
- HCG
- Keywords
- Intrauterine insemination, IUI, HCG
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCGDrug
Also called Pregnyl
Women will be given HCG before IUI
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | IUI at time of HCG Receives: Drug: HCG |
| Group B | Active comparator | IUI 12 hours after HCG Receives: Drug: HCG |
| Group C | Active comparator | IUI 34-36 hours after HCG Receives: Drug: HCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after IUI) divided by the number of IUI cycles
Measured: 4-6 weeks after IUI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJul 2019 (estimated)
- Study completionAug 2019 (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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Ibrahem Eid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Ibrahem Eid, Mansoura University
- Investigators
- Mohamed I Eid, Dr, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330705
- Sponsor's protocol ID
- MIE3
- Status last verified
- Jan 2019
- First submitted
- 31 Dec 2014
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Human Chorionic Gonadotropin Administration in Intrauterine Insemination Cycles
- ClinicalTrials.gov ID
- NCT02330705
- Acronym / sponsor ID
- MIE3
- Conditions
- Infertility
- Keywords
- Intrauterine insemination, IUI, HCG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Mohamed Ibrahem EidUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 5 Jan 2015 (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.
Evaluation of the effect of altering the timing of human chorionic gonadotropin (HCG) administration on the clinical pregnancy rate in intrauterine insemination (IUI) cycles.
Detailed description
Women will be randomly divided into 3 groups; the first group will undergo IUI at the time HCG administration, the second group will undergo IUI 12 hours after HCG administration and the third group will undergo IUI 34-36 hours after HCG administration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: HCGIUI at time of HCG |
| Group B | Active comparator | Drug: HCGIUI 12 hours after HCG |
| Group C | Active comparator | Drug: HCGIUI 34-36 hours after HCG |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Mild male factor infertility or unexplained infertility.
Key exclusion criteria (7 listed)
- Advanced male factor infertility.
- Polycystic ovary syndrome (PCOS) as defined by the Rotterdam criteria.
- Endometriosis.
- Tubal disease.
- Uterine abnormalities or myoma.
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 |
|---|---|---|
| HCGAlso: PregnylWomen will be given HCG before IUI | Drug | Group A, Group B, Group C |
Primary outcome
Clinical pregnancy rate
Time frame: 4-6 weeks after IUI
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 4-6 weeks after IUI) divided by the number of IUI cycles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed I Eid, Dr principal investigator
Mansoura University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HCG in people with Infertility, run by Mohamed Ibrahem Eid at 2 sites 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 7 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 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Mohamed I Eid, Dr (+201225401274, dr_moh_eid@yahoo.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: 4-6 weeks after IUI). 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 25 Jan 2019; AzTrials last refreshed its copy on 6 Nov 2026.