InfertilityNCT02397642
Dual Trigger Versus Booster Dose of HCG
A study testing IVF/ICSI and Human Chorionic Gonadotropin in people with Infertility, run by Cairo University at 3 sites in Egypt.
Trial summary
To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles triggered with GnRH agonist. Two strategies are compared dual trigger with GnRH agonist plus 1000 IU of HCG or triggering with GnRH and giving a booster dose of HCG (1500 IU) on the day of ovum pickup. Read more about this study
- Who is it for?
- Ages 20 to 37 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- IVF/ICSI and Human Chorionic Gonadotropin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesEgypt
- Study dates
- Mar 2015to Jan 2018
- Phase
- Interventional
- 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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- High responder females undergoing antagonist protocol IVF/ICSI cycle
- More than 14 MII oocytes
- Estradiol more than 3500 pg/ml on day of trigger
Who cannot join
- Any other protocol
- Normal or poor responders
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
Cairo
Adam International hospital
Giza
Nile IVF center
Giza
About this study
Official title: Dual Trigger Versus Booster Dose of HCG on Ovum Pickup Day in Antagonist IVF/ICSI Cycles Triggered With GnRH Agonist in High Responder Females to Salvage the Luteal Phase
To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles triggered with GnRH agonist. Two strategies are compared dual trigger with GnRH agonist plus 1000 IU of HCG or triggering with GnRH and giving a booster dose of HCG (1500 IU) on the day of ovum pickup.
- Conditions
- Infertility
- Being tested
- IVF/ICSI, Human Chorionic Gonadotropin
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVF/ICSIProcedure or surgery
Human Chorionic GonadotropinDrug
given in different doses and timing to support the luteal phase
| Study group | Role | What they receive |
|---|---|---|
| Dual trigger | Active comparator | GnRH agonist plus 1000 IU of HCG to trigger final maturation Receives: Procedure: IVF/ICSI; Drug: Human Chorionic Gonadotropin |
| Booster HCG dose | Active comparator | GnRH agonist only to trigger final maturation followed by a booster dose of 1500 IU of HCG on the day of ovum pickup Receives: Procedure: IVF/ICSI; Drug: Human Chorionic Gonadotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
The number of cycles with a evidence of a gestational sac with fetal pulstaions after 5 weeks from pregnancy test
Measured: 1 year
Secondary outcomes (1)
OHSS rate
The number of cycles with evidence of OHSS
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJan 2018
- Study completionJan 2018
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Nile Ivf Center, Cairo, Egypt, Adam International Hospital
- Responsible party
- Principal investigator, Yasmin Ahmed Bassiouny, Cairo University
- Investigators
- Sarwat Ahwany, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397642
- Sponsor's protocol ID
- 12015
- Status last verified
- Jan 2018
- First submitted
- 16 Mar 2015
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Trigger Versus Booster Dose of HCG on Ovum Pickup Day in Antagonist IVF/ICSI Cycles Triggered With GnRH Agonist in High Responder Females to Salvage the Luteal Phase
- ClinicalTrials.gov ID
- NCT02397642
- Acronym / sponsor ID
- 12015
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Nile Ivf Center, Cairo, Egypt, Adam International Hospital
- Study start
- Mar 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 25 Mar 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.
To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles triggered with GnRH agonist. Two strategies are compared dual trigger with GnRH agonist plus 1000 IU of HCG or triggering with GnRH and giving a booster dose of HCG (1500 IU) on the day of ovum pickup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual trigger | Active comparator | Procedure: IVF/ICSI, Drug: Human Chorionic GonadotropinGnRH agonist plus 1000 IU of HCG to trigger final maturation |
| Booster HCG dose | Active comparator | Procedure: IVF/ICSI, Drug: Human Chorionic GonadotropinGnRH agonist only to trigger final maturation followed by a booster dose of 1500 IU of HCG on the day of ovum pickup |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- High responder females undergoing antagonist protocol IVF/ICSI cycle
- More than 14 MII oocytes
- Estradiol more than 3500 pg/ml on day of trigger
Key exclusion criteria (2 listed)
- Any other protocol
- Normal or 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 |
|---|---|---|
| IVF/ICSI | Procedure or surgery | Booster HCG dose, Dual trigger |
| Human Chorionic Gonadotropingiven in different doses and timing to support the luteal phase | Drug | Booster HCG dose, Dual trigger |
Primary outcome
Clinical pregnancy rate
Time frame: 1 year
The number of cycles with a evidence of a gestational sac with fetal pulstaions after 5 weeks from pregnancy test
1 secondary outcome
OHSS rate
Time frame: 1 year
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 29 Jan 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.
Sarwat Ahwany, MD study director
Cairo University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVF/ICSI and Human Chorionic Gonadotropin in people with Infertility, run by Cairo University at 3 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 3 inclusion and 2 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 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
Clinical pregnancy rate (time frame: 1 year). 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 29 Jan 2018.