InfertilityPhase 3NCT03039049
GNRH Agonist Trigger and Modified Luteal Phase Adding a Bolus of GnRHa at the Time of Implantation: a RCT
A Phase 3 study testing Triptorelin 0.1 mg in people with Infertility, run by Centre Hospitalier Universitaire Ibn Rochd at 2 sites in Algeria.
Trial summary
Purpose:The aim of this project is to prospectively determine whether a single dose of GnRH-agonist administered at the time of implantation increases or not the reproductive outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm injection(ICSI) triggered by a GnRH-agonist followed by a… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Triptorelin 0.1 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 2 sitesAlgeria
- Study dates
- Mar 2014to Mar 2017
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female age < 40 years No uterine (fibroids, mullerian malformations), ovarian ( endometrioma) or adnexa (hydrosalpinx) abnormalities• Baseline FSH and LH < 12 IU/l.Patients with at least one embryo at transfer time
Who cannot join
- Very high risk of OHSS (> 30 follicles > 12 mm the day of ovulation triggering). • Reduced ovarian reserve
- Fertilization failure
- Severe endocrinopathy
- Azoospermia
Trial locations and contacts
2 sites in 1 country.
Algeria2 sites
Ibnrochd Clinic
Constantine, 25000
Ibnrochd IVF center
Constantine, 25000
About this study
Official title: GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Mid-luteal Bolus of GnRHa: a Randomised Controlled Trial.
Purpose:The aim of this project is to prospectively determine whether a single dose of GnRH-agonist administered at the time of implantation increases or not the reproductive outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic gonadotropin (hCG 1500 IU) the day of oocyte retrieval.
Read the detailed description
It has been reported in previous publications that the ovarian hyperstimulation syndrome (OHSS) was eliminated when GnRH agonist was used to trigger ovulation and the delivery rate has improved after modified luteal support especially when a small bolus of hCG is used on the day of oocyte retrieval. (OMEGA/HCG 1500 IU).
However, a risk difference of 7% in delivery rates is still in favor of HCG trigger. Thus, further modifications in the luteal phase supplementation are required in order to optimise the reproductive outcome after GnRH-agonist triggering.
Recently, many papers showed, that independently of the GnRH analogue used to prevent the premature LH surge, the addition of GnRH-agonist during the luteal phase seems to be beneficial in terms of pregnancy. Nevertheless, their use in practice is not yet admitted because of controversial results in terms of efficacy and safety particularly on the conceptus.
- Conditions
- Infertility
- Being tested
- Triptorelin 0.1 mg
- Keywords
- GnRH agonist trigger, IVF, Luteal phase support, Mid-luteal GnRH agonist
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorelin 0.1 mgDrug
Also called Decapeptyl 0.1 mg
a single dose of Triptorelin 0.1 mg subcutaneously administered 6 days after oocyte retrieval.
| Study group | Role | What they receive |
|---|---|---|
| GnRH agonist | Experimental | Drug: Triptorelin 0.1mg Triptorelin 0.1 mg administered subcutaneously 6 days after ovum pick-up (OPU) in IVF/ICSI cycles triggered by triptorelin 0.2 mg.
Other Names:
• Decapeptyl 0.1 mg Receives: Drug: Triptorelin 0.1 mg |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
implantation rate
number of gestational sacs per number of embryos transferred
Measured: Time Frame: 5 weeks after IVF/ICSI
Secondary outcomes (4)
positive pregnancy test
confirmed by beta-hCG 14 days post embryo transfer
Measured: Time Frame: 2 weeks after IVF/ICSI
Ongoing pregnancy
presence of foetal heart beat at 12 weeks of gestation
Measured: Time Frame: 12 weeks after IVF/ICSI
Delivery rate
birth of baby beyond 26 weeks of gestation
Measured: Time Frame: 26 weeks after IVF/ICSI
Early pregnancy loss
loss of embryo before 5 weeks of gestation, chemical pregnancy and extra-uterine pregnancy
Measured: Time Frame: miscarriage before 5 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startMar 2014
- Primary completionMar 2017
- Study completionMar 2017
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Ibn Rochd
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, benmachiche abdelhamid, Centre Hospitalier Universitaire Ibn Rochd
- Investigators
- Abdelhamid Benmachiche, M.D, Principal investigator, Ibn roch infertility centre, cité boussouf, Constantine Algeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039049
- Sponsor's protocol ID
- 02053779
- Status last verified
- Jul 2017
- First submitted
- 30 Jan 2017
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GnRH Agonist Trigger and Modified Luteal Phase Support, Adding a Mid-luteal Bolus of GnRHa: a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT03039049
- Acronym / sponsor ID
- 02053779
- Conditions
- Infertility
- Keywords
- GnRH agonist trigger, IVF, Luteal phase support, Mid-luteal GnRH agonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Ibn RochdUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 1 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.
Purpose:The aim of this project is to prospectively determine whether a single dose of GnRH-agonist administered at the time of implantation increases or not the reproductive outcome in patients undergoing in vitro fertilization ( IVF)/ intracytoplasmatic sperm injection(ICSI) triggered by a GnRH-agonist followed by a small bolus of human chorionic gonadotropin (hCG 1500 IU) the day of oocyte retrieval.
Detailed description
It has been reported in previous publications that the ovarian hyperstimulation syndrome (OHSS) was eliminated when GnRH agonist was used to trigger ovulation and the delivery rate has improved after modified luteal support especially when a small bolus of hCG is used on the day of oocyte retrieval. (OMEGA/HCG 1500 IU).
However, a risk difference of 7% in delivery rates is still in favor of HCG trigger. Thus, further modifications in the luteal phase supplementation are required in order to optimise the reproductive outcome after GnRH-agonist triggering.
Recently, many papers showed, that independently of the GnRH analogue used to prevent the premature LH surge, the addition of GnRH-agonist during the luteal phase seems to be beneficial in terms of pregnancy. Nevertheless, their use in practice is not yet admitted because of controversial results in terms of efficacy and safety particularly on the conceptus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRH agonist | Experimental | Drug: Triptorelin 0.1 mgDrug: Triptorelin 0.1mg Triptorelin 0.1 mg administered subcutaneously 6 days after ovum pick-up (OPU) in IVF/ICSI cycles triggered by triptorelin 0.2 mg. Other Names: • Decapeptyl 0.1 mg |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Female age < 40 years No uterine (fibroids, mullerian malformations), ovarian ( endometrioma) or adnexa (hydrosalpinx) abnormalities• Baseline FSH and LH < 12 IU/l.Patients with at least one embryo at transfer time
Key exclusion criteria (4 listed)
- Very high risk of OHSS (> 30 follicles > 12 mm the day of ovulation triggering). • Reduced ovarian reserve
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 |
|---|---|---|
| Triptorelin 0.1 mgAlso: Decapeptyl 0.1 mga single dose of Triptorelin 0.1 mg subcutaneously administered 6 days after oocyte retrieval. | Drug | GnRH agonist |
Primary outcome
implantation rate
Time frame: Time Frame: 5 weeks after IVF/ICSI
number of gestational sacs per number of embryos transferred
4 secondary outcomes
positive pregnancy test
Time frame: Time Frame: 2 weeks after IVF/ICSI
Ongoing pregnancy
Time frame: Time Frame: 12 weeks after IVF/ICSI
Delivery rate
Time frame: Time Frame: 26 weeks after IVF/ICSI
Early pregnancy loss
Time frame: Time Frame: miscarriage before 5 weeks of gestation
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 7 Jul 2017.
- Individual participant dataSharing planned: No
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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.
Abdelhamid Benmachiche, M.D principal investigator
Ibn roch infertility centre, cité boussouf, Constantine Algeria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triptorelin 0.1 mg in people with Infertility, run by Centre Hospitalier Universitaire Ibn Rochd at 2 sites in Algeria.
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: finished, as of the sponsor's last update on 7 Jul 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 Algeria. 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?
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?
implantation rate (time frame: Time Frame: 5 weeks after IVF/ICSI). 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 7 Jul 2017.