InfertilityPhase 2/3NCT02290002
Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome
A Phase 2/3 study testing Calcium Dobesilate and coasting in people with Infertility, run by khalid abd aziz mohamed at 1 site in Egypt.
Trial summary
The purpose of this study is to compare the effect of oral Calcium Dobesilate versus costing in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI). Read more about this study
- Who is it for?
- Ages 23 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Calcium Dobesilate and coasting
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2014to Dec 2016
- Phase
- Phase 2/3
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Infertile women undergoing intracytoplasmic sperm injection or polycystic ovarian syndrome (PCO) with one of the following:
- Presence of more than 20 follicles by ultrasound
- E2 more than 3000 pg/ml
- Retrieval of more than 15 follicles
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the effect of oral Calcium Dobesilate versus costing in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).
Read the detailed description
Two hundred and twenty women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Calcium Dobesilate group), 1 cap / 8 hs Doxium ( 500mg) will be given at day of HCG injection and for 3 weeks ; while in group B (Coasting group), coasting (withholding gonadotrophins while maintaining pituitary suppression) follow up every day by measuring E2 for 3 days then either giving triggering or cycle cancellation is done
- Conditions
- Infertility
- Being tested
- Calcium Dobesilate, coasting
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium DobesilateDrug
Also called doxium
1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given at day of HCG injection and for 21 days
coastingOther
In group B, coasting (withholding gonadotrophins while maintaining pituitary suppression) for 3 days then either giving triggering or cycle cancellation is done
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | In group A, (Calcium Dobesilate group), 1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given from at day of HCG injection and for 21 days. Receives: Drug: Calcium Dobesilate |
| group B | Active comparator | In group B, coasting (withholding gonadotrophins while maintaining pituitary suppression) for 3 days then either giving triggering or cycle cancellation is done Receives: Other: coasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with ovarian hyperstimulation syndrome (OHSS)
this will be assessed by:
Clinically:
Abdominal bloating Mild abdominal pain Nausea ± vomiting Oliguria Acute respiratory distress syndrome
By ultrasound Ovarian size usually ˃8 cm Ultrasound evidence of ascites
Laboratory Haemoconcentration haematocrit ˃45% Hypoproteinaemia
Measured: every two weeks for eight weeks
Secondary outcomes (1)
pregnancy rate
β-hCG (serum hCG test) will be checked 14 days after embryos transfer
Measured: 14 days after embryos transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2016
- Study completionDec 2016
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- khalid abd aziz mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, khalid abd aziz mohamed, Benha University
- Investigators
- ahmed saad, MD, Study chair, lecturer of ob/gynkhalid mohamed, MD, Study director, lecturer of ob/gyn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290002
- Sponsor's protocol ID
- ahmed-khalid 8
- Status last verified
- Feb 2017
- First submitted
- 8 Nov 2014
- Last updated
- 14 Feb 2017
- 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 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Dobesilate Versus Coasting for Prevention of Ovarian Hyperstimulation Syndrome
- ClinicalTrials.gov ID
- NCT02290002
- Acronym / sponsor ID
- ahmed-khalid 8
- Conditions
- Infertility
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- khalid abd aziz mohamedUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Nov 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.
The purpose of this study is to compare the effect of oral Calcium Dobesilate versus costing in the prevention of ovarian hyperstimulation syndrome (OHSS) in high-risk women underwent intracytoplasmic sperm injection (ICSI).
Detailed description
Two hundred and twenty women at risk of ovarian hyperstimulation syndrome during ICSI cycles will be randomly scheduled into two equal groups. In group A, (Calcium Dobesilate group), 1 cap / 8 hs Doxium ( 500mg) will be given at day of HCG injection and for 3 weeks ; while in group B (Coasting group), coasting (withholding gonadotrophins while maintaining pituitary suppression) follow up every day by measuring E2 for 3 days then either giving triggering or cycle cancellation is done
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: Calcium DobesilateIn group A, (Calcium Dobesilate group), 1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given from at day of HCG injection and for 21 days. |
| group B | Active comparator | Other: coastingIn group B, coasting (withholding gonadotrophins while maintaining pituitary suppression) for 3 days then either giving triggering or cycle cancellation is done |
Who may qualify
- Ages
- 23 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Infertile women undergoing intracytoplasmic sperm injection or polycystic ovarian syndrome (PCO) with one of the following:
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 |
|---|---|---|
| Calcium DobesilateAlso: doxium1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given at day of HCG injection and for 21 days | Drug | group A |
| coastingIn group B, coasting (withholding gonadotrophins while maintaining pituitary suppression) for 3 days then either giving triggering or cycle cancellation is done | Other | group B |
Primary outcome
Number of participants with ovarian hyperstimulation syndrome (OHSS)
Time frame: every two weeks for eight weeks
this will be assessed by: Clinically: Abdominal bloating Mild abdominal pain Nausea ± vomiting Oliguria Acute respiratory distress syndrome By ultrasound Ovarian size usually ˃8 cm Ultrasound evidence of ascites Laboratory Haemoconcentration haematocrit ˃45% Hypoproteinaemia
1 secondary outcome
pregnancy rate
Time frame: 14 days after embryos 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 14 Feb 2017.
- 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.
ahmed saad, MD study chair
lecturer of ob/gyn
khalid mohamed, MD study director
lecturer of ob/gyn
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Calcium Dobesilate and coasting in people with Infertility, run by khalid abd aziz mohamed 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 4 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 14 Feb 2017. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Number of participants with ovarian hyperstimulation syndrome (OHSS) (time frame: every two weeks for eight weeks). 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 14 Feb 2017.