Ovarian Hyperstimulation SyndromePhase 3OHSSNCT01427335
Calcium for Prevention of Ovarian Hyperstimulation Syndrome
A Phase 3 study testing calcium and 0.9 % saline in people with Ovarian Hyperstimulation Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
There are many protocols for prevention of ovarian hyperstimulation syndrome, intravenous calcium is a novel protocol. But still there is lack of evidence of it is real effect in prevention of OHSS \& the mechanism of its action is still questionable . Read more about this study
- Who is it for?
- Ages 20 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- What is being tested?
- calcium and 0.9 % saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2011to Sep 2013
- Phase
- Phase 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 20 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- infertile women aged 20 to 38 years.
- BMI ranged from 18 to 40.
- serum FSH within normal limits( 1-12IU /l)
- presented with ovarian response suggestive of being at risk of developing OHSS because of the presence of at least 15 follicles of 10 mm or greater on the day of hCG administration.
Who cannot join
- endocrinopathies.
- a systemic disease.
- using any medication (e.g., insulin-sensitizing drugs and GnRH antagonists.
- patients need coasting for high risk of OHSS.
- patients need cycle cancellation.
- severe male infertility requiring testicular sperm extraction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Intravenous Calcium Infusion Effectively Prevent OHSS : a Randomised Controlled Trial
There are many protocols for prevention of ovarian hyperstimulation syndrome, intravenous calcium is a novel protocol. But still there is lack of evidence of it is real effect in prevention of OHSS \& the mechanism of its action is still questionable . In the study the investigators try to search for the evidence for its effect \& the real mechanism for its action.
Read the detailed description
The study population will be divided into 2groups each containing 100 infertile couples candidate for ICSI.
Group (A)active group: administration of 10% Intravenous calcium gluconate 10 ml in 200 mL of physiologic saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup. Intravenous infusion was performed within 30 minutes.
Group (B): placebo group: administration of 200 mL of 0.9% saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup. Intravenous infusion was performed within 30 minutes
- Conditions
- Ovarian Hyperstimulation Syndrome
- Being tested
- calcium, 0.9 % saline
- Keywords
- OHSS, ICSI, calcium injection
- Medical subject headings
- Ovarian Hyperstimulation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calciumDrug
Also called Calcium intravenous infsuion
intravenous infusion of 10 % calcium gluconate 10 mL in 200 mL of physiologic saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup were administered in study group.
Intravenous infusion was performed within 30 minutes
0.9 % salineDrug
0.9 % saline intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| saline | Placebo comparator | 0.9% saline intravenous infusion Receives: Drug: 0.9 % saline |
| calcium | Experimental | Calcium intravenous infusion Receives: Drug: calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
OHSS rate
ovarain hyperstimulation syndrome
Measured: 2 years
Secondary outcomes (1)
clinical pregnancy rate
positive pregnancy test and positive fetal heart beat after 6 weeks gestaional age
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionSep 2013
- Study completionSep 2013
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 Ovarian Hyperstimulation SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed El-khayat, Cairo University
- Investigators
- Waleed M El-Khayat, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427335
- Sponsor's protocol ID
- 192011
- Acronym
- OHSS
- Status last verified
- Jul 2014
- First submitted
- 31 Aug 2011
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
El-Khayat W, Elsadek M. Calcium infusion for the prevention of ovarian hyperstimulation syndrome: a double-blind randomized controlled trial. Fertil Steril. 2015 Jan;103(1):101-5. doi: 10.1016/j.fertnstert.2014.09.046.
PubMed 25552412
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Intravenous Calcium Infusion Effectively Prevent OHSS : a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01427335
- Acronym / sponsor ID
- OHSS / 192011
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- OHSS, ICSI, calcium injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 1 Sep 2011 (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.
There are many protocols for prevention of ovarian hyperstimulation syndrome, intravenous calcium is a novel protocol. But still there is lack of evidence of it is real effect in prevention of OHSS \& the mechanism of its action is still questionable . In the study the investigators try to search for the evidence for its effect \& the real mechanism for its action.
Detailed description
The study population will be divided into 2groups each containing 100 infertile couples candidate for ICSI.
Group (A)active group: administration of 10% Intravenous calcium gluconate 10 ml in 200 mL of physiologic saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup. Intravenous infusion was performed within 30 minutes.
Group (B): placebo group: administration of 200 mL of 0.9% saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup. Intravenous infusion was performed within 30 minutes
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saline | Placebo comparator | Drug: 0.9 % saline0.9% saline intravenous infusion |
| calcium | Experimental | Drug: calciumCalcium intravenous infusion |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- infertile women aged 20 to 38 years.
- BMI ranged from 18 to 40.
- serum FSH within normal limits( 1-12IU /l)
- presented with ovarian response suggestive of being at risk of developing OHSS because of the presence of at least 15 follicles of 10 mm or greater on the day of hCG administration.
Key exclusion criteria (6 listed)
- endocrinopathies.
- a systemic disease.
- using any medication (e.g., insulin-sensitizing drugs and GnRH antagonists.
- patients need coasting for high risk of OHSS.
- patients need cycle cancellation.
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 |
|---|---|---|
| calciumAlso: Calcium intravenous infsuionintravenous infusion of 10 % calcium gluconate 10 mL in 200 mL of physiologic saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup were administered in study group. Intravenous infusion was performed within 30 minutes | Drug | calcium |
| 0.9 % saline0.9 % saline intravenous infusion | Drug | saline |
Primary outcome
OHSS rate
Time frame: 2 years
ovarain hyperstimulation syndrome
1 secondary outcome
clinical pregnancy rate
Time frame: 2 years
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 9 Jul 2014.
- Derived from this study: PubMed 25552412El-Khayat W, Elsadek M. Calcium infusion for the prevention of ovarian hyperstimulation syndrome: a double-blind randomized controlled trial. Fertil Steril. 2015 Jan;103(1):101-5. doi: 10.1016/j.fertnstert.2014.09.046.
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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.
Waleed M El-Khayat, M.D. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing calcium and 0.9 % saline in people with Ovarian Hyperstimulation Syndrome, run by Cairo 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 4 inclusion and 6 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 9 Jul 2014. 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 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?
OHSS rate (time frame: 2 years). 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 NCT01427335, 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 9 Jul 2014.