Pituitary DownregulationPhase 2/3NCT03044756
Omitting GnRH-antagonist Dose on the Day of Ovulation Trigger
A Phase 2/3 study testing Omit Citrotide 0.25 dose on the day of triggering of ovulation in people with Pituitary Downregulation, run by Assiut University at 2 sites in Egypt.
Trial summary
Omitting the GnRH antagonist on the day of the trigger can be cost effective and more convenient to the women. We will study the impact of omitting the antagonist dose in a prospective randomized trial Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Pituitary Downregulation
- What is being tested?
- Omit Citrotide 0.25 dose on the day of triggering of ovulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2017to 30 Dec 2017
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All antagonist cycle ivf who agree to participate
Who cannot join
- expected poor responders.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Osama Abdalmageed
Asyut, Non-US/Non-Canadian, 71111
Osama Abdalmageed, 1007972027, drosamast1981@gmail.com
- Recruiting
Osama Abdalmageed
Asyut, Non-US/Non-Canadian, 71111
Osama Abdalmageed, drosamast1981@gmail.com
About this study
Official title: Impact of Omitting GnR-antagonist on Ovulation Trigger Day in the Fresh Autologous IVF/ICSI Cycles
Omitting the GnRH antagonist on the day of the trigger can be cost effective and more convenient to the women. We will study the impact of omitting the antagonist dose in a prospective randomized trial
- Conditions
- Pituitary Downregulation
- Being tested
- Omit Citrotide 0.25 dose on the day of triggering of ovulation
- Keywords
- GnRH antagonist, Pituitary downregulation, IVF, ICSI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omit Citrotide 0.25 dose on the day of triggering of ovulationDrug
Omit Citrotide 0.25 dose on the day of triggering of ovulation
| Study group | Role | What they receive |
|---|---|---|
| -ve arm | Experimental | The women who do not receive the GnRH antagonist dose on the day of triggering of ovulation (omitted GnRH antagonist arm) Receives: Drug: Omit Citrotide 0.25 dose on the day of triggering of ovulation |
| +ve arm | No intervention | The women who receive the routine dose of GnRH antagonist on the day of triggering of ovulation (the usual protocol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of retrieved oocytes
total number and maturation of the retrieved oocytes
Measured: One Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start1 Jan 2017
- Primary completion30 Aug 2017 (estimated)
- Study completion30 Dec 2017 (estimated)
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 Pituitary DownregulationStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Saber Thabet Abdalmageed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044756
- Sponsor's protocol ID
- Omit
- Status last verified
- Feb 2017
- First submitted
- 1 Feb 2017
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The regulations in Assiut University do not allow protected patient data sharing
Publications
Chang HJ, Lee JR, Jee BC, Suh CS, Lee WD, Kim SH. Cessation of gonadotropin-releasing hormone antagonist on triggering day in flexible multiple-dose protocol: A randomized controlled study. Clin Exp Reprod Med. 2013 Jun;40(2):83-9. doi: 10.5653/cerm.2013.40.2.83. Epub 2013 Jun 30.
PubMed 23875164
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Omitting GnR-antagonist on Ovulation Trigger Day in the Fresh Autologous IVF/ICSI Cycles
- ClinicalTrials.gov ID
- NCT03044756
- Acronym / sponsor ID
- Omit
- Conditions
- Pituitary Downregulation
- Keywords
- GnRH antagonist, Pituitary downregulation, IVF, ICSI
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Aug 2017 (estimated)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 7 Feb 2017 (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.
Omitting the GnRH antagonist on the day of the trigger can be cost effective and more convenient to the women. We will study the impact of omitting the antagonist dose in a prospective randomized trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| -ve arm | Experimental | Drug: Omit Citrotide 0.25 dose on the day of triggering of ovulationThe women who do not receive the GnRH antagonist dose on the day of triggering of ovulation (omitted GnRH antagonist arm) |
| +ve arm | No intervention | –The women who receive the routine dose of GnRH antagonist on the day of triggering of ovulation (the usual protocol) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All antagonist cycle ivf who agree to participate
Key exclusion criteria (1 listed)
- expected poor responders.
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 |
|---|---|---|
| Omit Citrotide 0.25 dose on the day of triggering of ovulationOmit Citrotide 0.25 dose on the day of triggering of ovulation | Drug | -ve arm |
Primary outcome
Number of retrieved oocytes
Time frame: One Month
total number and maturation of the retrieved oocytes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Background: PubMed 23875164Chang HJ, Lee JR, Jee BC, Suh CS, Lee WD, Kim SH. Cessation of gonadotropin-releasing hormone antagonist on triggering day in flexible multiple-dose protocol: A randomized controlled study. Clin Exp Reprod Med. 2013 Jun;40(2):83-9. doi: 10.5653/cerm.2013.40.2.83. Epub 2013 Jun 30.
- Individual participant dataSharing planned: No. The regulations in Assiut University do not allow protected patient data sharing
Related trials for Pituitary Downregulation
Not yet recruiting
Surgery and ART For Endometrioma
Ovarian Endometrioma, Infertility, Female
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.
2 sites 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 Omit Citrotide 0.25 dose on the day of triggering of ovulation in people with Pituitary Downregulation, run by Assiut University at 2 sites 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: status not confirmed, as of the sponsor's last update on 7 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 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of retrieved oocytes (time frame: One Month). 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 NCT03044756, 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 7 Feb 2017.