IVFNCT04265495
Dual Trigger, Urinary HCG or Recombinant HCG, Which is the Best !?
An observational study of IVF, run by Al Baraka Fertility Hospital at 1 site in Bahrain.
Trial summary
a comparative study among dual trigger, urinary HCG and recombinant HCG regarding the outcome of ICSI- antagonist cycles Read more about this study
- Who is it for?
- Ages 22 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IVF
- How many people
- 600 participants
- Where
- 1 siteBahrain
- Study dates
- 9 Feb 2020to 1 Dec 2021
- Phase
- Observational
- 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 22 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: patients <40 years of age who underwent IVF/ICSI cycles using a GnRH antagonist protocol, then at the time of triggering, we divided the patients to 3 groups by for triggering by a dual trigger, urinary HCG and recombinant HCG and then will check the outcome regarding the maturity and oocyte quality, implantation rate, clinical pregnancy rate as well as incidence of OHSS
Who may be able to join
- patients <40 years of age who underwent IVF/ICSI cycles using a GnRH antagonist protocol
Who cannot join
- age: > 40 years
- BMI > 30 ,
- long agonist protocol
- were chromosomal and genetic disorders, abnormal ultrasonogram of the uterine cavity
Trial locations and contacts
1 site in 1 country.
Bahrain1 site, 1 recruiting
- Recruiting
Al-BARAKA FERTILITY HOSPITAL
Manama, Adliya, 15006
AHMED BARAKAT, FRCOG, 0097336660500, ahmed_barakat@yahoo.com
Kamal Rageh, M.D, 0097333153871, dr_kamal_rageh@yahoo.com
About this study
Official title: Dual Trigger, Urinary HCG or Recombinant HCG, Which is the Best !? a Prospective Randomized Controlled Comparative Study
a comparative study among dual trigger, urinary HCG and recombinant HCG regarding the outcome of ICSI- antagonist cycles
Read the detailed description
a comparative study among dual trigger, urinary HCG and recombinant HCG regarding the outcome (oocyte quality, fertilization rate, implantation rate, clinical pregnancy rate as well as the incidence of OHSS) in ICSI- antagonist cycles
- Conditions
- IVF
- Keywords
- Dual trigger implantation,, HCG, OHSS, ANTAGONIST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DUAL TRIGGERING | PATIENTS WILL RECEIVE DUAL TRIGGERING | |
| URINARY HCG | PATIENTS WILL RECEIVE URINARY HCG | |
| RECOMBINANT HCG | PATIENTS WILL RECEIVE RECOMBINANT HCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate,
Measured: 4 WEEKS
implantation rate,
Measured: 2 WEEKS
incidence of OHSS.
Measured: 1 WEEK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start9 Feb 2020
- Primary completion30 Nov 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al Baraka Fertility Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kamal Rageh, Al Baraka Fertility Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265495
- Sponsor's protocol ID
- AlBarakaBH-KAMAL
- Status last verified
- Sep 2021
- First submitted
- 9 Feb 2020
- Last updated
- 28 Sep 2021
- 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 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Trigger, Urinary HCG or Recombinant HCG, Which is the Best !? a Prospective Randomized Controlled Comparative Study
- ClinicalTrials.gov ID
- NCT04265495
- Acronym / sponsor ID
- AlBarakaBH-KAMAL
- Conditions
- IVF
- Keywords
- Dual trigger implantation,, HCG, OHSS, ANTAGONIST
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Al Baraka Fertility HospitalUniversity, hospital or other
- Study start
- 9 Feb 2020 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 11 Feb 2020 (actual)
- 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.
a comparative study among dual trigger, urinary HCG and recombinant HCG regarding the outcome of ICSI- antagonist cycles
Detailed description
a comparative study among dual trigger, urinary HCG and recombinant HCG regarding the outcome (oocyte quality, fertilization rate, implantation rate, clinical pregnancy rate as well as the incidence of OHSS) in ICSI- antagonist cycles
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DUAL TRIGGERING | – | –PATIENTS WILL RECEIVE DUAL TRIGGERING |
| URINARY HCG | – | –PATIENTS WILL RECEIVE URINARY HCG |
| RECOMBINANT HCG | – | –PATIENTS WILL RECEIVE RECOMBINANT HCG |
Who may qualify
- Ages
- 22 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients <40 years of age who underwent IVF/ICSI cycles using a GnRH antagonist protocol, then at the time of triggering, we divided the patients to 3 groups by for triggering by a dual trigger, urinary HCG and recombinant HCG and then will check the outcome regarding the maturity and oocyte quality, implantation rate, clinical pregnancy rate as well as incidence of OHSS
Key inclusion criteria (1 listed)
- patients <40 years of age who underwent IVF/ICSI cycles using a GnRH antagonist protocol
Key exclusion criteria (4 listed)
- age: > 40 years
- BMI > 30 ,
- long agonist protocol
- were chromosomal and genetic disorders, abnormal ultrasonogram of the uterine cavity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clinical pregnancy rate,
Time frame: 4 WEEKS
implantation rate,
Time frame: 2 WEEKS
incidence of OHSS.
Time frame: 1 WEEK
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IVF, run by Al Baraka Fertility Hospital at 1 site in Bahrain.
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 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 28 Sep 2021. 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 Bahrain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kamal eldin Rageh, M.D. (0097333153871, dr_kamal_rageh@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy rate, (time frame: 4 WEEKS). The study lists 3 primary outcomes in all. 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 28 Sep 2021.