InfertilityNCT02158000
Aspiration of Excessive Endometrial Fluid at the Day of Ovum Retrieval Plus Diosmin in (ICSI) Cycles
A study testing group A in people with Infertility, run by Benha University at 1 site in Egypt.
Trial summary
To notify the effect of aspiration of excessive endometrial fluid in addition to Diosmin in cases undergoing intracytoplasmic sperm injection (ICSI) cycles. Read more about this study
- Who is it for?
- Ages 23 to 48 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- group A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2014to Nov 2021
- 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 23 to 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with excessive endometrial fluid by transvaginal ultrasound during ICSI cycles
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
To notify the effect of aspiration of excessive endometrial fluid in addition to Diosmin in cases undergoing intracytoplasmic sperm injection (ICSI) cycles.
Read the detailed description
Objectives: To notify the effect of aspiration of excessive endometrial fluid in addition to Diosmin in cases undergoing intracytoplasmic sperm injection (ICSI) cycles.
Study design: Prospective randomized controlled clinical trial.
Patients and Methods: 200 women with excessive endometrial fluid by transvaginal ultrasound during ICSI cycles are randomly scheduled into two equal groups. In group A, one tab every 8 hs Diosmin ( 500mg) beginning from the day of ovum retrieval in addition to aspiration of the fluid by an IUI catheter ; while in group B (control group), no thing is given or done. The main outcome measures are presence of the fluid on the day of embryo transfer and the pregnancy rate on those patients.
- Conditions
- Infertility
- Being tested
- group A
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group AOther
Also called Daflon
one tab every 8 hs Diosmin ( 500mg) beginning from the day of ovum retrieval in addition to aspiration of the fluid by an IUI catheter
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | In group A , 100 women with excessive endometrial fluid by transvaginal ultrasound during ICSI cycles are allocated to receive one tab / 8 hs of Diosmin ( 500mg) beginning from the day of ovum retrieval and for 3 days (till the day of embro trasfer) in addition to aspiration of the fluid by an IUI catheter. Receives: Other: group A |
| Group B | No intervention | In group B (control group) 100 women with excessive endometrial fluid by transvaginal ultrasound during ICSI cycles, no thing will be done |
What is being measured
The primary outcome is the main question the study is designed to answer.
the pregnancy rate
is assessed by :serum hCG test Beta sub-unit of hCG (serum hCG test)
Measured: is checked 16 days after embryos transfer
Secondary outcomes (1)
presence of the fluid on the day of embryo transfer
detection of excessive endometrial fluid by transvaginal ultrasound during ICSI cycles
Measured: at the day of embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionNov 2021
- Study completionNov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Benha 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, khalid abd aziz mohamed, Benha University
- Investigators
- khalid mohamed, Study chair, Department of Obstetrics and Gynecology, Benha University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158000
- Sponsor's protocol ID
- khalid-ahmed 5
- Status last verified
- Jun 2022
- First submitted
- 5 Jun 2014
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: on research gate
Publications
Saad AS, Mohamed KAA. Aspiration with Diosmin Intake in Endometrial Cavity Fluid Accumulation in ART Cycles: A Randomized Controlled Trial. J Obstet Gynaecol India. 2023 Aug;73(4):336-342. doi: 10.1007/s13224-023-01791-7. Epub 2023 Aug 31.
PubMed 37701088
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aspiration of Excessive Endometrial Fluid at the Day of Ovum Retrieval Plus Diosmin in (ICSI) Cycles
- ClinicalTrials.gov ID
- NCT02158000
- Acronym / sponsor ID
- khalid-ahmed 5
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Nov 2021 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 6 Jun 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.
To notify the effect of aspiration of excessive endometrial fluid in addition to Diosmin in cases undergoing intracytoplasmic sperm injection (ICSI) cycles.
Detailed description
Objectives: To notify the effect of aspiration of excessive endometrial fluid in addition to Diosmin in cases undergoing intracytoplasmic sperm injection (ICSI) cycles.
Study design: Prospective randomized controlled clinical trial.
Patients and Methods: 200 women with excessive endometrial fluid by transvaginal ultrasound during ICSI cycles are randomly scheduled into two equal groups. In group A, one tab every 8 hs Diosmin ( 500mg) beginning from the day of ovum retrieval in addition to aspiration of the fluid by an IUI catheter ; while in group B (control group), no thing is given or done. The main outcome measures are presence of the fluid on the day of embryo transfer and the pregnancy rate on those patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Other: group AIn group A , 100 women with excessive endometrial fluid by transvaginal ultrasound during ICSI cycles are allocated to receive one tab / 8 hs of Diosmin ( 500mg) beginning from the day of ovum retrieval and for 3 days (till the day of embro trasfer) in addition to aspiration of the fluid by an IUI catheter. |
| Group B | No intervention | –In group B (control group) 100 women with excessive endometrial fluid by transvaginal ultrasound during ICSI cycles, no thing will be done |
Who may qualify
- Ages
- 23 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with excessive endometrial fluid by transvaginal ultrasound during ICSI cycles
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| group AAlso: Daflonone tab every 8 hs Diosmin ( 500mg) beginning from the day of ovum retrieval in addition to aspiration of the fluid by an IUI catheter | Other | Group A |
Primary outcome
the pregnancy rate
Time frame: is checked 16 days after embryos transfer
is assessed by :serum hCG test Beta sub-unit of hCG (serum hCG test)
1 secondary outcome
presence of the fluid on the day of embryo transfer
Time frame: at the day of embryo transfer
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 28 Jun 2022.
- Derived from this study: PubMed 37701088Saad AS, Mohamed KAA. Aspiration with Diosmin Intake in Endometrial Cavity Fluid Accumulation in ART Cycles: A Randomized Controlled Trial. J Obstet Gynaecol India. 2023 Aug;73(4):336-342. doi: 10.1007/s13224-023-01791-7. Epub 2023 Aug 31.
- Individual participant dataSharing planned: Yes. on research gate
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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.
khalid mohamed study chair
Department of Obstetrics and Gynecology, Benha University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing group A in people with Infertility, run by Benha 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: finished, as of the sponsor's last update on 28 Jun 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. 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?
the pregnancy rate (time frame: is checked 16 days after embryos transfer). 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 NCT02158000, which also lists 1 linked publication.
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 28 Jun 2022.