LUF - Luteinised Unruptured Follicle SyndromePhase 4NCT03580031
Booster Dose of HCG for Unruptured Follicle in Non IVF/ICSI Cycles
A Phase 4 study testing hCG and Saline Solution in people with LUF - Luteinised Unruptured Follicle Syndrome, run by Tanta University at 1 site in Egypt.
Trial summary
This study will be conducted to assess the effect of booster dose of hCG on the unruptured follicles in non IVF/ICSI cycles. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- LUF - Luteinised Unruptured Follicle Syndrome
- What is being tested?
- hCG and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2018to 1 Jan 2021
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Ordinary stimulated cycles
- IUI stimulated cycles
- Unruptured follicle after 10000 IU IM HCG triggering
Who cannot join
- IVF/ICSI cycles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Booster Dose of Human Chorionic Gonadotrophin for Unruptured Follicle in Non IVF/ICSI Cycles: A Randomized Controlled Study
This study will be conducted to assess the effect of booster dose of hCG on the unruptured follicles in non IVF/ICSI cycles.
Read the detailed description
In this study enrolled patients (n=160) who underwent controlled ovarian stimulation and timed intercourse with unruptured mature graffian follicle 48 hours after IM 10,000 IU HCG dose. Patients were allocated randomly into intervention group and control group. In the intervention group another booster dose (10,000 IU of hCG) was given IM while in the control group 2 ml normal saline was given IM leaving follicles for spontaneous rupture
- Being tested
- hCG, Saline Solution
- Keywords
- LUF, HCG, Booster dose, Ovulation rate, pregnancy rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hCGDrug
A booster dose (10,000 IU of hCG) was given IM 48 hours after first triggering dose
Saline SolutionDrug
2 ml of normal saline will be injected 48 hours after first triggering dose
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | HCG IM 10,000 IU Im 48 hours after first triggering dose Receives: Drug: hCG |
| Control group | Placebo comparator | Saline 2m Injection im 48 hours after the first triggering dose Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ovulation rate
rupture of dominant follicle manifested by disappearance of follicle and presence of free fluid in douglas pouch
Measured: 48 hours
Secondary outcomes (1)
Pregnancy rate
Number of cases with positive serum pregnancy test
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start1 Aug 2018
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LUF - Luteinised Unruptured Follicle SyndromeStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Model description
- Cohort groups with parallel allocation
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman S Dawood, MD, Tanta University
- Investigators
- Ayman Dawood, MD, Principal investigator, Lecturer at Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03580031
- Sponsor's protocol ID
- Ayman HCG
- Status last verified
- Feb 2022
- First submitted
- 26 Jun 2018
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be displayed
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Booster Dose of Human Chorionic Gonadotrophin for Unruptured Follicle in Non IVF/ICSI Cycles: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03580031
- Acronym / sponsor ID
- Ayman HCG
- Keywords
- LUF, HCG, Booster dose, Ovulation rate, pregnancy rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 9 Jul 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.
This study will be conducted to assess the effect of booster dose of hCG on the unruptured follicles in non IVF/ICSI cycles.
Detailed description
In this study enrolled patients (n=160) who underwent controlled ovarian stimulation and timed intercourse with unruptured mature graffian follicle 48 hours after IM 10,000 IU HCG dose. Patients were allocated randomly into intervention group and control group. In the intervention group another booster dose (10,000 IU of hCG) was given IM while in the control group 2 ml normal saline was given IM leaving follicles for spontaneous rupture
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Cohort groups with parallel allocation
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: hCGHCG IM 10,000 IU Im 48 hours after first triggering dose |
| Control group | Placebo comparator | Drug: Saline SolutionSaline 2m Injection im 48 hours after the first triggering dose |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ordinary stimulated cycles
- IUI stimulated cycles
- Unruptured follicle after 10000 IU IM HCG triggering
Key exclusion criteria (1 listed)
- IVF/ICSI cycles
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 |
|---|---|---|
| hCGA booster dose (10,000 IU of hCG) was given IM 48 hours after first triggering dose | Drug | Study group |
| Saline Solution2 ml of normal saline will be injected 48 hours after first triggering dose | Drug | Control group |
Primary outcome
Ovulation rate
Time frame: 48 hours
rupture of dominant follicle manifested by disappearance of follicle and presence of free fluid in douglas pouch
1 secondary outcome
Pregnancy rate
Time frame: 15 days
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 Feb 2022.
- Individual participant dataSharing planned: No. No individual participant data will be displayed
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.
Ayman Dawood, MD principal investigator
Lecturer at Tanta 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 hCG and Saline Solution in people with LUF - Luteinised Unruptured Follicle Syndrome, run by Tanta 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 3 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: finished, as of the sponsor's last update on 21 Feb 2022. 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. 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.
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?
Ovulation rate (time frame: 48 hours). 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 21 Feb 2022.