Ovarian Hyperstimulation SyndromePhase 3OHSSNCT02620605
The Influence of Timing of Cabergoline Initiation on Prevention of OHSS
A Phase 3 study testing Late Cabergoline 0.5mg and Early Cabergoline 0.5mg in people with Ovarian Hyperstimulation Syndrome, run by Mona M Shaban at 1 site in Egypt.
Trial summary
Study the effect of early cabergoline administration in prevention of occurrence or decreasing the severity of OHSS in patients undergoing intra cytoplasmic sperm injection.And its effect on oocyte maturation,fertilization and pregnancy rate.. Read more about this study
- Who is it for?
- Ages 19 to 35 years, women only
- Conditions the study is for
- Ovarian Hyperstimulation Syndrome
- What is being tested?
- Late Cabergoline 0.5mg and Early Cabergoline 0.5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2017to Apr 2019
- 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 19 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female less than 35 years under going Intra cytoplasmic sperm injection cycle for infertility (tubal factor or un explained infertility).
- 18 or more oocyte 11 mm in diameter and/or E2 is more than 4000 pg/ml at any day of the stimulation cycle before or at HCG trigger
Who cannot join
- patient with one ovary
- patients already receiving cabergoline treatment
- Severe Male factor infertility.
- Thyroid dysfunction.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
IVF department in Kasr Alaini hospital,private IVF centre
Cairo, 1325
Sherine H Gad Allah, MD, 01097665573 ext. +2, sherinehosny@gmail.com
About this study
Official title: The Influence of Timing of Cabergoline Initiation on Prevention of Ovarian Hyper Stimulation Syndrome in Patients Undergoing Intra Cytoplasmic Sperm Injection .
Study the effect of early cabergoline administration in prevention of occurrence or decreasing the severity of OHSS in patients undergoing intra cytoplasmic sperm injection.And its effect on oocyte maturation,fertilization and pregnancy rate..
Read the detailed description
Patients less than 35years undergoing Intra Cytoplasmic Sperm Injection for infertility scheduled for gonadotropin releasing hormone agonist long protocol of ovarian stimulation.
All patient will receive combined oral contraceptive pills (Gynera, Schering-plow: plough) starting from day 5 of cycle that precedes the stimulated cycle .On day 21 of that cycle all patients will start to receive Gonadotrophin releasing hormone agonist in the form of (decapeptyl 0.1 sc daily and continued till the day of HCG administration).
To ensure that all patients are completely down regulated and desensitized ,trans-vaginal ultrasound will be performed at day 2-3 of menses of stimulated cycle to ensure endometrial thickness less than 5 mm and no ovarian cysts.Also serum E2 level is less than 50 pg/ml.
Then all patients will start to receive Gonadotrophin ( HMG) (Menogon, ferring pharmaceuticals, Germany) 225 IU (international unit) Intramuscular Injection daily,with continuous scheduled follow up of ovarian response by serial trans -vaginal US to assess follicular growth together will serial serum E2 starting from day 6 of cycle and onwards.With adjustments of gonadotropin dose and monitoring frequency based on patient response.
During follow up once the recruited patients fulfilling the inclusion criteria (serum E2 equal or more than 4000 pg/ml and /or 18 or more follicles of 11 mm diameter or more at any day of stimulation),they will be allocated randomly by computer generated cards and assigned by sealed envelopes by the treating doctor at the outpatient clinic.
Group A : will receive cabergoline 0.5 mg/day for 8 days, starting in the day of HCG (human chorionic gonadotropin ) injection.
Group B: will receive cabergoline 0.5 mg/day once the criteria of inclusion criteria is fulfilled and continued till the day of human chorionic gonadotropin (HCG ) trigger and continued 8 days more from day of trigger .
- Conditions
- Ovarian Hyperstimulation Syndrome
- Being tested
- Late Cabergoline 0.5mg, Early Cabergoline 0.5mg
- Keywords
- Cabergoline, Ovarian Hyper Stimulation Syndrome (OHSS)
- 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.
Late Cabergoline 0.5mgDrug
Also called Dostenix (Dostinex®, Pfizer Australia Pty Ltd )
Cabergoline 0.5mg will be administrated once daily at day of HCG trigger and continued for 8days
Early Cabergoline 0.5mgDrug
Also called Dostinex (Dostinex®, Pfizer Australia Pty Ltd )
Cabergoline 0.5mg will be administrated once daily when E2 is more than 4000pg/ml and /or more than 18 follicles of 11mm diameter or more are encountered at any day of the controlled ovarian hyper-stimulation and before HCG trigger to be continued for 8days after HCG trigger.
| Study group | Role | What they receive |
|---|---|---|
| Late administration of Cabirgoline 0.5 mg | Active comparator | Cabergoline 0.5mg (Dostinex®, Pfizer Australia Pty Ltd ) administrated once daily started on day of HCG triggering and continued for 8 days. Receives: Drug: Late Cabergoline 0.5mg |
| Early administration of Cabirgoline 0.5mg | Experimental | Cabergoline 0.5mg(Dostinex®, Pfizer Australia Pty Ltd ) once daily stared once patients fulfilling the inclusion criteria at any day of cycle and continued for 8 days post HCG trigger. Receives: Drug: Early Cabergoline 0.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence and severity of OHSS
either early or late OHSS (early OHSS is the occurrence within 9 days after OPU and occurrence after 10 days was classified as late OHSS.The severity of OHSS was graded according to the criteria of Navot et al. (1992). Moderate OHSS in particular is characterized by abdominal distension and discomfort, nausea±vomiting±diarrhoea, enlarged ovaries 5-12 cm and ultrasonographic evidence of ascites. Severe OHSS is characterized by variable ovarian enlargement; massive ascites±hydrothorax; breathing difficulties; haematocrit >45%; white blood cell count >15 000; oligouria; creatinine 1.0-1.5;liver dysfunction; and anasarca oedema.)
Measured: 2 to 4weeks after trigger
Secondary outcomes (4)
Number of M|| oocytes.
Measured: maximum one day after ovum pick up
Fertilization rate.
fertilization rate (the presence of two pronuclei (2PN) at the time of fertilization assessment, 16 to 19 hours after ICSI),
Measured: 16 to 19 hours after ICSI
Clinical Pregnancy rate
Clinical pregnancy was considered to be the presence of a gestational sac with fetal heart activity.
Measured: 2 to 4 weeks after positive pregnancy test
implantation rate
implantation rate( the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred)
Measured: 2 to 4 weeks after positive pregnancy test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study start20 Dec 2017
- Primary completionDec 2018 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Hyperstimulation SyndromeStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mona M Shaban
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mona M Shaban, Cairo University
- Investigators
- Mona M Shaban, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620605
- Sponsor's protocol ID
- C123
- Acronym
- OHSS
- Status last verified
- Apr 2018
- First submitted
- 24 Nov 2015
- Last updated
- 10 Apr 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 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Timing of Cabergoline Initiation on Prevention of Ovarian Hyper Stimulation Syndrome in Patients Undergoing Intra Cytoplasmic Sperm Injection .
- ClinicalTrials.gov ID
- NCT02620605
- Acronym / sponsor ID
- OHSS / C123
- Conditions
- Ovarian Hyperstimulation Syndrome
- Keywords
- Cabergoline, Ovarian Hyper Stimulation Syndrome (OHSS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Mona M ShabanUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 3 Dec 2015 (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.
Study the effect of early cabergoline administration in prevention of occurrence or decreasing the severity of OHSS in patients undergoing intra cytoplasmic sperm injection.And its effect on oocyte maturation,fertilization and pregnancy rate..
Detailed description
Patients less than 35years undergoing Intra Cytoplasmic Sperm Injection for infertility scheduled for gonadotropin releasing hormone agonist long protocol of ovarian stimulation.
All patient will receive combined oral contraceptive pills (Gynera, Schering-plow: plough) starting from day 5 of cycle that precedes the stimulated cycle .On day 21 of that cycle all patients will start to receive Gonadotrophin releasing hormone agonist in the form of (decapeptyl 0.1 sc daily and continued till the day of HCG administration).
To ensure that all patients are completely down regulated and desensitized ,trans-vaginal ultrasound will be performed at day 2-3 of menses of stimulated cycle to ensure endometrial thickness less than 5 mm and no ovarian cysts.Also serum E2 level is less than 50 pg/ml.
Then all patients will start to receive Gonadotrophin ( HMG) (Menogon, ferring pharmaceuticals, Germany) 225 IU (international unit) Intramuscular Injection daily,with continuous scheduled follow up of ovarian response by serial trans -vaginal US to assess follicular growth together will serial serum E2 starting from day 6 of cycle and onwards.With adjustments of gonadotropin dose and monitoring frequency based on patient response.
During follow up once the recruited patients fulfilling the inclusion criteria (serum E2 equal or more than 4000 pg/ml and /or 18 or more follicles of 11 mm diameter or more at any day of stimulation),they will be allocated randomly by computer generated cards and assigned by sealed envelopes by the treating doctor at the outpatient clinic.
Group A : will receive cabergoline 0.5 mg/day for 8 days, starting in the day of HCG (human chorionic gonadotropin ) injection.
Group B: will receive cabergoline 0.5 mg/day once the criteria of inclusion criteria is fulfilled and continued till the day of human chorionic gonadotropin (HCG ) trigger and continued 8 days more from day of trigger .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Late administration of Cabirgoline 0.5 mg | Active comparator | Drug: Late Cabergoline 0.5mgCabergoline 0.5mg (Dostinex®, Pfizer Australia Pty Ltd ) administrated once daily started on day of HCG triggering and continued for 8 days. |
| Early administration of Cabirgoline 0.5mg | Experimental | Drug: Early Cabergoline 0.5mgCabergoline 0.5mg(Dostinex®, Pfizer Australia Pty Ltd ) once daily stared once patients fulfilling the inclusion criteria at any day of cycle and continued for 8 days post HCG trigger. |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female less than 35 years under going Intra cytoplasmic sperm injection cycle for infertility (tubal factor or un explained infertility).
- 18 or more oocyte 11 mm in diameter and/or E2 is more than 4000 pg/ml at any day of the stimulation cycle before or at HCG trigger
Key exclusion criteria (4 listed)
- patient with one ovary
- patients already receiving cabergoline treatment
- Severe Male factor infertility.
- Thyroid dysfunction.
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 |
|---|---|---|
| Late Cabergoline 0.5mgAlso: Dostenix (Dostinex®, Pfizer Australia Pty Ltd )Cabergoline 0.5mg will be administrated once daily at day of HCG trigger and continued for 8days | Drug | Late administration of Cabirgoline 0.5 mg |
| Early Cabergoline 0.5mgAlso: Dostinex (Dostinex®, Pfizer Australia Pty Ltd )Cabergoline 0.5mg will be administrated once daily when E2 is more than 4000pg/ml and /or more than 18 follicles of 11mm diameter or more are encountered at any day of the controlled ovarian hyper-stimulation and before HCG trigger to be continued for 8days after HCG trigger. | Drug | Early administration of Cabirgoline 0.5mg |
Primary outcome
Occurrence and severity of OHSS
Time frame: 2 to 4weeks after trigger
either early or late OHSS (early OHSS is the occurrence within 9 days after OPU and occurrence after 10 days was classified as late OHSS.The severity of OHSS was graded according to the criteria of Navot et al. (1992). Moderate OHSS in particular is characterized by abdominal distension and discomfort, nausea±vomiting±diarrhoea, enlarged ovaries 5-12 cm and ultrasonographic evidence of ascites. Severe OHSS is characterized by variable ovarian enlargement; massive ascites±hydrothorax; breathing difficulties; haematocrit >45%; white blood cell count >15 000; oligouria; creatinine 1.0-1.5;liver dysfunction; and anasarca oedema.)
4 secondary outcomes
Number of M|| oocytes.
Time frame: maximum one day after ovum pick up
Fertilization rate.
Time frame: 16 to 19 hours after ICSI
Clinical Pregnancy rate
Time frame: 2 to 4 weeks after positive pregnancy test
implantation rate
Time frame: 2 to 4 weeks after positive pregnancy test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 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.
Mona M Shaban, MD principal investigator
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 Late Cabergoline 0.5mg and Early Cabergoline 0.5mg in people with Ovarian Hyperstimulation Syndrome, run by Mona M Shaban 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Apr 2018. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherine H Gad Allah, MD (01097665573 ext. +2, sherinehosny@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence and severity of OHSS (time frame: 2 to 4weeks after trigger). 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 10 Apr 2018.