InfertilityPhase 4NCT02620124
GnRH Agonist as Luteal Support in FET Cycles
A Phase 4 study testing Natural cycle: Triptorelin acetate 0.1 mg and Hormone replacement cycle and triptorelin acetate 0.1 mg in people with Infertility, run by Turku University Hospital.
Trial summary
Back ground: A single dose of GnRH analogue in the luteal phase is reported to improve the outcome of IVF/ICSI treatments but the effect in FET cycles has not been reported. Aim: To compare the results of frozen thawed embryo transfers with and without GnRHa analogue support Primary end point: IR, PR, on going PR… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Natural cycle: Triptorelin acetate 0.1 mg and Hormone replacement cycle and triptorelin acetate 0.1 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Oct 2015
- Phase
- Phase 4
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 20 - 45 year old women comig to frozen thawed embryo transfer
Who cannot join
- The age of the woman over 42 years during the initial ICF/ICSI- treatment from which the embryos derive
- Abnormal uterus
- Known abnormality of karyotype of the woman or her partner
- Severe male factor as an exclusive reason for subfertility
- Allegy for triptorelin acetate
About this study
Official title: GnRH Anonist as Luteal Support in Frozen-thawed Embryo Transfer Cycles
Back ground: A single dose of GnRH analogue in the luteal phase is reported to improve the outcome of IVF/ICSI treatments but the effect in FET cycles has not been reported.
Aim: To compare the results of frozen thawed embryo transfers with and without GnRHa analogue support Primary end point: IR, PR, on going PR Secondary end point: hCH, E2 and progesterone levels 14 days after thawing
- Conditions
- Infertility
- Being tested
- Natural cycle: Triptorelin acetate 0.1 mg, Hormone replacement cycle and triptorelin acetate 0.1 mg
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural cycle: Triptorelin acetate 0.1 mgDrug
A single dose of triptorelin acetate 0.1 s.c. was giwen when the age of the transferred embryo was six days in additon to standard micronized progesterone 400 mg vaginally
Hormone replacement cycle and triptorelin acetate 0.1 mgDrug
A single dose of triptorelin acetate 0.1 s.c. was giwen when the age of the transferred embryo was six days in addition to standard Estradiol and progesterone support
| Study group | Role | What they receive |
|---|---|---|
| Natural cycle, control | No intervention | Treatment cycles with normal luteal support with progesteron |
| Natural cycle, intervention | Experimental | Treatment cycles with normal luteal support with progesteron and a single dose of 0.1 mg triptorelin when the age of the embryo was 6 days: Intervention is the additional 0.1 mg triptorelin as described in the previous sentence. Receives: Drug: Natural cycle: Triptorelin acetate 0.1 mg |
| Hormone replacement cycle, control | No intervention | Standard hormone replacement cycle with estrogen and progesteron |
| Hormone replacement cycle, intervention | Experimental | Standard hormone replacement cycle with estrogen and progesteron and a single dose of 0.1 mg triptorelin when the age of the embryo was 6 days Receives: Drug: Natural cycle: Triptorelin acetate 0.1 mg; Drug: Hormone replacement cycle and triptorelin acetate 0.1 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Measured: five weeks after the embryo transfer
Implantation rate
Measured: five weeks after the embryo transfer
Ongoing pregnancy rate
Measured: ten weeks after the embryo transfer
Secondary outcomes (1)
hCG- level
Measured: 14 days after thawing of the embryos
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startMay 2013
- Primary completionApr 2015
- Study completionOct 2015
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Varpu Jokimaa, MD, PhD, Principal investigator, Hospital District of the South-West Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02620124
- Sponsor's protocol ID
- T5/2013
- Status last verified
- Nov 2016
- First submitted
- 30 Nov 2015
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GnRH Anonist as Luteal Support in Frozen-thawed Embryo Transfer Cycles
- ClinicalTrials.gov ID
- NCT02620124
- Acronym / sponsor ID
- T5/2013
- Conditions
- Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- May 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Dec 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.
Back ground: A single dose of GnRH analogue in the luteal phase is reported to improve the outcome of IVF/ICSI treatments but the effect in FET cycles has not been reported.
Aim: To compare the results of frozen thawed embryo transfers with and without GnRHa analogue support Primary end point: IR, PR, on going PR Secondary end point: hCH, E2 and progesterone levels 14 days after thawing
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Natural cycle, control | No intervention | –Treatment cycles with normal luteal support with progesteron |
| Natural cycle, intervention | Experimental | Drug: Natural cycle: Triptorelin acetate 0.1 mgTreatment cycles with normal luteal support with progesteron and a single dose of 0.1 mg triptorelin when the age of the embryo was 6 days: Intervention is the additional 0.1 mg triptorelin as described in the previous sentence. |
| Hormone replacement cycle, control | No intervention | –Standard hormone replacement cycle with estrogen and progesteron |
| Hormone replacement cycle, intervention | Experimental | Drug: Natural cycle: Triptorelin acetate 0.1 mg, Drug: Hormone replacement cycle and triptorelin acetate 0.1 mgStandard hormone replacement cycle with estrogen and progesteron and a single dose of 0.1 mg triptorelin when the age of the embryo was 6 days |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 20 - 45 year old women comig to frozen thawed embryo transfer
Key exclusion criteria (5 listed)
- The age of the woman over 42 years during the initial ICF/ICSI- treatment from which the embryos derive
- Abnormal uterus
- Known abnormality of karyotype of the woman or her partner
- Severe male factor as an exclusive reason for subfertility
- Allegy for triptorelin acetate
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 |
|---|---|---|
| Natural cycle: Triptorelin acetate 0.1 mgA single dose of triptorelin acetate 0.1 s.c. was giwen when the age of the transferred embryo was six days in additon to standard micronized progesterone 400 mg vaginally | Drug | Hormone replacement cycle, intervention, Natural cycle, intervention |
| Hormone replacement cycle and triptorelin acetate 0.1 mgA single dose of triptorelin acetate 0.1 s.c. was giwen when the age of the transferred embryo was six days in addition to standard Estradiol and progesterone support | Drug | Hormone replacement cycle, intervention |
Primary outcome
Pregnancy rate
Time frame: five weeks after the embryo transfer
Implantation rate
Time frame: five weeks after the embryo transfer
Ongoing pregnancy rate
Time frame: ten weeks after the embryo transfer
1 secondary outcome
hCG- level
Time frame: 14 days after thawing of the embryos
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 23 Nov 2016.
- Individual participant dataSharing planned: No
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Varpu Jokimaa, MD, PhD principal investigator
Hospital District of the South-West Finland
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Natural cycle: Triptorelin acetate 0.1 mg and Hormone replacement cycle and triptorelin acetate 0.1 mg in people with Infertility, run by Turku University Hospital.
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 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: finished, as of the sponsor's last update on 23 Nov 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Pregnancy rate (time frame: five weeks after the embryo transfer). 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 23 Nov 2016.