GnRHa;LPSPhase 1NCT02908438
Gonadotrophin Releasing Hormone Agonist Addition for Luteal Support in In-vitro Fertilization and Embryo Transfer Cycles
A Phase 1 study testing Gonadotrophin releasing hormone agonist(GnRHa) in people with GnRHa;LPS, run by Northwest Women's and Children's Hospital, Xi'an, Shaanxi.
Trial summary
The study was designed to investigate the effect of luteal-phase administration of gonadotrophin releasing hormone agonist(GnRHa) on pregnancy outcomes in in-vitro fertilization-embryo transfer. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- GnRHa;LPS
- What is being tested?
- Gonadotrophin releasing hormone agonist(GnRHa)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2017
- Phase
- Phase 1
- 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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age < 37 years;
- One or more high quality embryos have been got in IVF/ICSI treatment;
- To transfer at lest 2 fresh embryos;
- Uterine endometrial thickness ≥ 7mm;
- Patients have signed informed consents.
Who cannot join
- ≥3 IVF/ICSI/FET cycles and no pregnancy;
- Polycystic ovary syndrome(PCOS);
- uterine malformation;
- endometriosis
- patients with a history of recurrent pregnancy loss.
Trial locations and contacts
No sites are listed yet.
About this study
The study was designed to investigate the effect of luteal-phase administration of gonadotrophin releasing hormone agonist(GnRHa) on pregnancy outcomes in in-vitro fertilization-embryo transfer.
- Conditions
- GnRHa;LPS
- Being tested
- Gonadotrophin releasing hormone agonist(GnRHa)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonadotrophin releasing hormone agonist(GnRHa)Drug
GnRHa group receive three injections of GnRHa(Decapeptyl) ,0.1 mg s.c. on the day of ET, and D3 and D6 after ET in addition to routine LPS.
| Study group | Role | What they receive |
|---|---|---|
| GnRHa group | Experimental | Intervention: additional GnRHa for routine LPS GnRHa group receive three injections of GnRHa(Decapeptyl) ,0.1 mg s.c. on the day of ET, and D3 and D6 after ET in addition to routine LPS. Receives: Drug: Gonadotrophin releasing hormone agonist(GnRHa) |
| control group | No intervention | Control group receive only the routine LPS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GnRHa;LPSStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwest Women's and Children's Hospital, Xi'an, Shaanxi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908438
- Sponsor's protocol ID
- ART-GnRHa for LPS
- Status last verified
- Sep 2016
- First submitted
- 12 Sep 2016
- Last updated
- 21 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gonadotrophin Releasing Hormone Agonist Addition for Luteal Support in In-vitro Fertilization and Embryo Transfer Cycles
- ClinicalTrials.gov ID
- NCT02908438
- Acronym / sponsor ID
- ART-GnRHa for LPS
- Conditions
- GnRHa;LPS
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Northwest Women's and Children's Hospital, Xi'an, ShaanxiUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Sep 2017 (estimated)
- First posted
- 21 Sep 2016 (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.
The study was designed to investigate the effect of luteal-phase administration of gonadotrophin releasing hormone agonist(GnRHa) on pregnancy outcomes in in-vitro fertilization-embryo transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRHa group | Experimental | Drug: Gonadotrophin releasing hormone agonist(GnRHa)Intervention: additional GnRHa for routine LPS GnRHa group receive three injections of GnRHa(Decapeptyl) ,0.1 mg s.c. on the day of ET, and D3 and D6 after ET in addition to routine LPS. |
| control group | No intervention | –Control group receive only the routine LPS. |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age < 37 years;
- One or more high quality embryos have been got in IVF/ICSI treatment;
- To transfer at lest 2 fresh embryos;
- Uterine endometrial thickness ≥ 7mm;
- Patients have signed informed consents.
Key exclusion criteria (5 listed)
- ≥3 IVF/ICSI/FET cycles and no pregnancy;
- Polycystic ovary syndrome(PCOS);
- uterine malformation;
- endometriosis
- patients with a history of recurrent pregnancy loss.
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 |
|---|---|---|
| Gonadotrophin releasing hormone agonist(GnRHa)GnRHa group receive three injections of GnRHa(Decapeptyl) ,0.1 mg s.c. on the day of ET, and D3 and D6 after ET in addition to routine LPS. | Drug | GnRHa group |
Primary outcome
pregnancy rate
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2016.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gonadotrophin releasing hormone agonist(GnRHa) in people with GnRHa;LPS, run by Northwest Women's and Children's Hospital, Xi'an, Shaanxi.
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 5 inclusion and 5 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 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Shan Liu, PHD (86+18991932450, 123564787@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy rate (time frame: up to 12 months). 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 21 Sep 2016.