InfertilityPhase 3NCT01007851
Single Dose Gonadotropin-releasing Hormone (GnRH) Agonist Administration in the Luteal Phase of GnRH Antagonist Stimulated ICSI-ET Cycles
A Phase 3 study testing triptorelin acetate and NaCl %0.9 in people with Infertility, run by V.K.V. American Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial summary
GnRH agonist administration in the luteal phase was reported to beneficially affect clinical outcome of ICSI-ET cycles. This randomized controlled trial evaluates the effect of a single dose GnRH agonist administered in the luteal phase on the outcome of ICSI - ET cycles stimulated with the fixed GnRH antagonist… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- triptorelin acetate and NaCl %0.9
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2006to Dec 2007
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol, oocyte pick-up and ICSI.
- Embryo transfer performed on day 3
Who cannot join
- Participation in another trial that was being conducted in our unit at the same time.
- Preimplantation genetic screening cycles.
- Day 5 embryo transfers.
Trial locations and contacts
1 site in 1 country.
About this study
GnRH agonist administration in the luteal phase was reported to beneficially affect clinical outcome of ICSI-ET cycles. This randomized controlled trial evaluates the effect of a single dose GnRH agonist administered in the luteal phase on the outcome of ICSI - ET cycles stimulated with the fixed GnRH antagonist protocol. Women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol were included. In addition to routine luteal phase support with progesterone women were randomized to receive a single dose of GnRH agonist or placebo on the sixth day after ICSI.Ongoing pregnancy rate was the primary outcome measure.
- Conditions
- Infertility
- Being tested
- triptorelin acetate, NaCl %0.9
- Keywords
- GnRH agonist, GnRH antagonist, IVF, ICSI, assisted reproduction, luteal phase
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triptorelin acetateDrug
single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer
NaCl %0.9Drug
0.1 ml sterile saline sc injection 3 days after embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| GnRH agonist | Experimental | Not described Receives: Drug: triptorelin acetate |
| Saline | Placebo comparator | Not described Receives: Drug: NaCl %0.9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy beyond 20th gestational week
Secondary outcomes (2)
clinical pregnancy rate
Embryo implantation rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2009 (estimated)
- Study startSep 2006
- Study completionDec 2007
Why it stopped: Lower than anticipated recruitment
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
Sponsor and investigators
- Lead sponsor
- V.K.V. American Hospital, Istanbul
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007851
- Sponsor's protocol ID
- AH-48/07
- Status last verified
- Nov 2009
- First submitted
- 3 Nov 2009
- Last updated
- 4 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Gonadotropin-releasing Hormone (GnRH) Agonist Administration in the Luteal Phase of GnRH Antagonist Stimulated ICSI-ET Cycles
- ClinicalTrials.gov ID
- NCT01007851
- Acronym / sponsor ID
- AH-48/07
- Conditions
- Infertility
- Keywords
- GnRH agonist, GnRH antagonist, IVF, ICSI, assisted reproduction, luteal phase
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lower than anticipated recruitment
- Lead sponsor
- V.K.V. American Hospital, IstanbulUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Dec 2007 (actual)
- First posted
- 4 Nov 2009 (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.
GnRH agonist administration in the luteal phase was reported to beneficially affect clinical outcome of ICSI-ET cycles. This randomized controlled trial evaluates the effect of a single dose GnRH agonist administered in the luteal phase on the outcome of ICSI - ET cycles stimulated with the fixed GnRH antagonist protocol. Women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol were included. In addition to routine luteal phase support with progesterone women were randomized to receive a single dose of GnRH agonist or placebo on the sixth day after ICSI.Ongoing pregnancy rate was the primary outcome measure.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRH agonist | Experimental | Drug: triptorelin acetate |
| Saline | Placebo comparator | Drug: NaCl %0.9 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women undergoing embryo transfer following controlled ovarian hyperstimulation with a fixed GnRH antagonist protocol, oocyte pick-up and ICSI.
- Embryo transfer performed on day 3
Key exclusion criteria (3 listed)
- Participation in another trial that was being conducted in our unit at the same time.
- Preimplantation genetic screening cycles.
- Day 5 embryo transfers.
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 acetatesingle dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer | Drug | GnRH agonist |
| NaCl %0.90.1 ml sterile saline sc injection 3 days after embryo transfer | Drug | Saline |
Primary outcome
Ongoing pregnancy beyond 20th gestational week
2 secondary outcomes
clinical pregnancy rate
Embryo implantation rate
Results and safety
The study was stopped early (reason given: Lower than anticipated recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 acetate and NaCl %0.9 in people with Infertility, run by V.K.V. American Hospital, Istanbul at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 4 Nov 2009. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Lower than anticipated recruitment). Results are not available in the source record.
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?
Ongoing pregnancy beyond 20th gestational week. 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 4 Nov 2009.