Intrauterine InseminationPhase 4NCT03920514
Timing and Intrauterine Insemination in Unexplained Infertility
A Phase 4 study testing hCG in people with Intrauterine Insemination, run by Sohag University.
Trial summary
to determine the most suitable time for administration of (human chorionic gonadotropin )hCG prior to intrauterine insemination (IUI) to optimize pregnancy outcome and to have the best success rates so the cases divided in to four groups according to the time of hCG administration . Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Intrauterine Insemination
- What is being tested?
- hCG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2019to 31 Dec 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Mild male infertility or unexplained infertility
Who cannot join
- Adanced male factor endometriosis uterine abnormality sever semen parameters i impairment according to WHO 2010 non ovulatory cycles bilatral tubal block
Trial locations and contacts
No sites are listed yet.
Mohamed Sabry Ebrahim, Lecture of obs and gyn contact
About this study
Official title: Different Timing of Intrauterine Insemination and Pregnancy Outcome in Patient With Unexplained Infertility :A Randomized Controlled Study
to determine the most suitable time for administration of (human chorionic gonadotropin )hCG prior to intrauterine insemination (IUI) to optimize pregnancy outcome and to have the best success rates so the cases divided in to four groups according to the time of hCG administration .
Read the detailed description
IUI with or without ovarian stimulation is a common treatment for infertility ,it is a simple procedure the semen is prepared in the laboratory and transferred by a catheter and injected intrauterine .ultrasound folliculometry is used for monitoring follicular growth where some clinicians prefer the natural cycles and others prefer ovarian stimulation and human chorionic gonadotropin (hCG)trigger for better timing .so cases will take induction and folliculometry will be done until the follicle reach 18mm trigger with hCG .women will be randomly divided to four groups .the first group will undergo IUI at 24 after trigger the second IUI at36 hour after trigger the thirdG at 48 after trigger and finaly the last group IUI will be done simultaneos with trigger the out come the number of pregnant women for each group.
- Conditions
- Intrauterine Insemination
- Being tested
- hCG
- Keywords
- infertility
- 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 or with IUI
| Study group | Role | What they receive |
|---|---|---|
| GROUP 1 | Active comparator | IUI 24 hours after hCGadminstration Receives: Drug: hCG |
| GROUP 2 | Active comparator | IUI 36 hours after hCG adminstration Receives: Drug: hCG |
| GROUP 3 | Active comparator | IUI 48 hours after hCG adminstration Receives: Drug: hCG |
| GROUP 4 | Active comparator | IUI at time of hCG adminstration Receives: Drug: hCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
Positive serum beta hCG test
Measured: 14 days after IUI
Secondary outcome
Clinical pregnancy defined as prescence of at least one Intrauterine gestational sac with fetal pole on Transvaginal scan
Measured: 4 weeks after insemination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start30 Apr 2019 (estimated)
- Primary completion30 Sep 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intrauterine InseminationStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Women will be randomly divided in to four groups the first Group will undergo IUI after 24 H of hCG administration the second g will undergo IUI after 36 h after hCG the third Group will undergo IUI after 48h of hCG administration the last Group will undergo IUI at the time of hCG adminstration
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salwa Sabry Ahmed Mohamed, Sohag University
- Investigators
- Allam Mohamed Abd elmonam, Professor of obs and gyn, Principal investigator, Faculty of medicine sohag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03920514
- Sponsor's protocol ID
- Intrauterine insemination
- Status last verified
- Apr 2019
- First submitted
- 16 Apr 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Aydin Y, Hassa H, Oge T, Tokgoz VY. A randomized study of simultaneous hCG administration with intrauterine insemination in stimulated cycles. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):444-8. doi: 10.1016/j.ejogrb.2013.07.022. Epub 2013 Aug 6.
PubMed 23932307Cantineau AE, Janssen MJ, Cohlen BJ, Allersma T. Synchronised approach for intrauterine insemination in subfertile couples. Cochrane Database Syst Rev. 2014 Dec 21;2014(12):CD006942. doi: 10.1002/14651858.CD006942.pub3.
PubMed 25528596Yumusak OH, Kahyaoglu S, Pekcan MK, Isci E, Cinar M, Tasci Y. Does intrauterine insemination timing matter for achieving pregnancy during ovulation induction using gonadotropins? A retrospective cohort study. J Chin Med Assoc. 2017 Jun;80(6):366-370. doi: 10.1016/j.jcma.2016.06.005. Epub 2016 Sep 27.
PubMed 27686502
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Timing of Intrauterine Insemination and Pregnancy Outcome in Patient With Unexplained Infertility :A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03920514
- Acronym / sponsor ID
- Intrauterine insemination
- Conditions
- Intrauterine Insemination
- Keywords
- infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 30 Apr 2019 (estimated)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 19 Apr 2019 (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.
to determine the most suitable time for administration of (human chorionic gonadotropin )hCG prior to intrauterine insemination (IUI) to optimize pregnancy outcome and to have the best success rates so the cases divided in to four groups according to the time of hCG administration .
Detailed description
IUI with or without ovarian stimulation is a common treatment for infertility ,it is a simple procedure the semen is prepared in the laboratory and transferred by a catheter and injected intrauterine .ultrasound folliculometry is used for monitoring follicular growth where some clinicians prefer the natural cycles and others prefer ovarian stimulation and human chorionic gonadotropin (hCG)trigger for better timing .so cases will take induction and folliculometry will be done until the follicle reach 18mm trigger with hCG .women will be randomly divided to four groups .the first group will undergo IUI at 24 after trigger the second IUI at36 hour after trigger the thirdG at 48 after trigger and finaly the last group IUI will be done simultaneos with trigger the out come the number of pregnant women for each group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- Women will be randomly divided in to four groups the first Group will undergo IUI after 24 H of hCG administration the second g will undergo IUI after 36 h after hCG the third Group will undergo IUI after 48h of hCG administration the last Group will undergo IUI at the time of hCG adminstration
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | Active comparator | Drug: hCGIUI 24 hours after hCGadminstration |
| GROUP 2 | Active comparator | Drug: hCGIUI 36 hours after hCG adminstration |
| GROUP 3 | Active comparator | Drug: hCGIUI 48 hours after hCG adminstration |
| GROUP 4 | Active comparator | Drug: hCGIUI at time of hCG adminstration |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Mild male infertility or unexplained infertility
Key exclusion criteria (1 listed)
- Adanced male factor endometriosis uterine abnormality sever semen parameters i impairment according to WHO 2010 non ovulatory cycles bilatral tubal block
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 or with IUI | Drug | GROUP 1, GROUP 2, GROUP 3, GROUP 4 |
Primary outcome
Primary outcome
Time frame: 14 days after IUI
Positive serum beta hCG test
Secondary outcome
Time frame: 4 weeks after insemination
Clinical pregnancy defined as prescence of at least one Intrauterine gestational sac with fetal pole on Transvaginal scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Background: PubMed 23932307Aydin Y, Hassa H, Oge T, Tokgoz VY. A randomized study of simultaneous hCG administration with intrauterine insemination in stimulated cycles. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):444-8. doi: 10.1016/j.ejogrb.2013.07.022. Epub 2013 Aug 6.
- Background: PubMed 25528596Cantineau AE, Janssen MJ, Cohlen BJ, Allersma T. Synchronised approach for intrauterine insemination in subfertile couples. Cochrane Database Syst Rev. 2014 Dec 21;2014(12):CD006942. doi: 10.1002/14651858.CD006942.pub3.
- Background: PubMed 27686502Yumusak OH, Kahyaoglu S, Pekcan MK, Isci E, Cinar M, Tasci Y. Does intrauterine insemination timing matter for achieving pregnancy during ovulation induction using gonadotropins? A retrospective cohort study. J Chin Med Assoc. 2017 Jun;80(6):366-370. doi: 10.1016/j.jcma.2016.06.005. Epub 2016 Sep 27.
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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 Sabry Ebrahim, Lecture of obs and gyn contact
Allam Mohamed Abd elmonam, Professor of obs and gyn principal investigator
Faculty of medicine sohag university
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hCG in people with Intrauterine Insemination, run by Sohag University.
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 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Salwa Sabry Ahmed, Candidate (+201022616301, drsalwasabry@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: 14 days after IUI). The study lists 2 primary outcomes in all. 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 NCT03920514, which also lists 3 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 19 Apr 2019.