Unexplained InfertilityNCT03461601
Uterine Flushing With Human Chorionic Gonadotrophin and Unexplained Infertility
A study testing HCG Uterine flushing, IUI and Vaginal flushing with 10 ml normal saline in people with Unexplained Infertility, run by Ahmed Walid Anwar Murad.
Trial summary
A prospective randomized study included 210 women with Unexplained infertility subjected to combined ovarian stimulation and Intrauterine insemination (IUI). Two equal groups. Study group, subjected to uterine flushing with Human chorionic gonadotropin (HCG) one day before IUI and control group subjected to IUI alone. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Unexplained Infertility
- What is being tested?
- HCG Uterine flushing, IUI and Vaginal flushing with 10 ml normal saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2014to 1 Jun 2017
- 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 18 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Unexplained infertility (UI)
Who cannot join
- body mass index (BMI) ≥35 kg/m2,
- Follicle Stimulating Hormone >10 International Unit /Litter in early follicular phase,
- diagnosed cause of infertility, menstrual cycle irregularity,
- ovarian cysts,
- sever cervical stenosis,
- former IUI,
- ongoing pregnancy and
- renal or hepatic diseases were all the exclusion criteria.
About this study
Official title: The Impact of Uterine Flushing With Human Chorionic Gonadotrophin Before Intrauterine Insemination on Pregnancy and Live Birth Rates in Women With Unexplained Infertility: A Randomized Controlled Trial
A prospective randomized study included 210 women with Unexplained infertility subjected to combined ovarian stimulation and Intrauterine insemination (IUI). Two equal groups. Study group, subjected to uterine flushing with Human chorionic gonadotropin (HCG) one day before IUI and control group subjected to IUI alone.
Read the detailed description
A prospective randomized study included 210 patients with Unexplained infertility subjected to coupled ovarian stimulation and Intrauterine insemination (IUI). Two equal groups. Study group, subjected to uterine flushing with Human chorionic gonadotropin (HCG) one day before IUI and control group subjected to IUI alone.
- Conditions
- Unexplained Infertility
- Being tested
- HCG Uterine flushing, IUI, Vaginal flushing with 10 ml normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCG Uterine flushingProcedure or surgery
HCG Uterine flushing was done one day before IUI with HCG (500 IU) in 10 ml of saline.
IUIProcedure or surgery
Intrauterine insemination (IUI)
Vaginal flushing with 10 ml normal salineProcedure or surgery
Flushing of the vagina with 10 ml of saline
| Study group | Role | What they receive |
|---|---|---|
| HCG uterine flushing group | Active comparator | Uterine flushing was done one day before Intrauterine insemination (IUI) with HCG (500 IU) in 10 ml of saline followed by Intrauterine insemination (IUI). Receives: Procedure: HCG Uterine flushing; Procedure: IUI |
| IUI alone group | Placebo comparator | Intrauterine insemination alone plus vaginal flushing with 10 ml normal saline Receives: Procedure: IUI; Procedure: Vaginal flushing with 10 ml normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth
Defined as pregnancies maintained beyond 20 weeks of gestation
Measured: 10 months of randomization
Secondary outcomes (3)
Chemical pregnancy
Defined as positive serum pregnancy test
Measured: One month after randomization
Clinical pregnancy
Defined by the presence of gestational sac with fetal heartbeats on ultrasound scan or histological identification of trophoblastic tissue.
Measured: Two months after randomization
Adverse effects
Nausea, vomiting, and pain
Measured: one hour of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start1 Jun 2014
- Primary completion1 Jun 2017
- Study completion1 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unexplained 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intrauterine injection of human chorionic gonadotropin before intrauterine insemination (IUI) compared to IUI alone
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Walid Anwar Murad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Walid Anwar Murad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03461601
- Sponsor's protocol ID
- 18144
- Status last verified
- Mar 2018
- First submitted
- 28 Feb 2018
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Uterine Flushing With Human Chorionic Gonadotrophin Before Intrauterine Insemination on Pregnancy and Live Birth Rates in Women With Unexplained Infertility: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03461601
- Acronym / sponsor ID
- 18144
- Conditions
- Unexplained Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Ahmed Walid Anwar MuradUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Jun 2017 (actual)
- First posted
- 12 Mar 2018 (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.
A prospective randomized study included 210 women with Unexplained infertility subjected to combined ovarian stimulation and Intrauterine insemination (IUI). Two equal groups. Study group, subjected to uterine flushing with Human chorionic gonadotropin (HCG) one day before IUI and control group subjected to IUI alone.
Detailed description
A prospective randomized study included 210 patients with Unexplained infertility subjected to coupled ovarian stimulation and Intrauterine insemination (IUI). Two equal groups. Study group, subjected to uterine flushing with Human chorionic gonadotropin (HCG) one day before IUI and control group subjected to IUI alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- intrauterine injection of human chorionic gonadotropin before intrauterine insemination (IUI) compared to IUI alone
| Arm | Type | Receives |
|---|---|---|
| HCG uterine flushing group | Active comparator | Procedure: HCG Uterine flushing, Procedure: IUIUterine flushing was done one day before Intrauterine insemination (IUI) with HCG (500 IU) in 10 ml of saline followed by Intrauterine insemination (IUI). |
| IUI alone group | Placebo comparator | Procedure: IUI, Procedure: Vaginal flushing with 10 ml normal salineIntrauterine insemination alone plus vaginal flushing with 10 ml normal saline |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Unexplained infertility (UI)
Key exclusion criteria (8 listed)
- body mass index (BMI) ≥35 kg/m2,
- Follicle Stimulating Hormone >10 International Unit /Litter in early follicular phase,
- diagnosed cause of infertility, menstrual cycle irregularity,
- ovarian cysts,
- sever cervical stenosis,
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 |
|---|---|---|
| HCG Uterine flushingHCG Uterine flushing was done one day before IUI with HCG (500 IU) in 10 ml of saline. | Procedure or surgery | HCG uterine flushing group |
| IUIIntrauterine insemination (IUI) | Procedure or surgery | HCG uterine flushing group, IUI alone group |
| Vaginal flushing with 10 ml normal salineFlushing of the vagina with 10 ml of saline | Procedure or surgery | IUI alone group |
Primary outcome
Live birth
Time frame: 10 months of randomization
Defined as pregnancies maintained beyond 20 weeks of gestation
3 secondary outcomes
Chemical pregnancy
Time frame: One month after randomization
Clinical pregnancy
Time frame: Two months after randomization
Adverse effects
Time frame: one hour of the procedure
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 12 Mar 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing HCG Uterine flushing, IUI and Vaginal flushing with 10 ml normal saline in people with Unexplained Infertility, run by Ahmed Walid Anwar Murad.
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 8 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 12 Mar 2018. 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. Some participants in this study may receive a placebo. 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?
Live birth (time frame: 10 months of randomization). 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 12 Mar 2018.