InfertilityNCT00516490
GnRH Agonist Administration in the Luteal Phase of ICSI-ET Cycles
A study testing triptorelin acetate and Na Cl %0.9 in people with Infertility, run by V.K.V. American Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial summary
A single dose GnRH agonist administration in the luteal phase of assisted reproduction cycles was reported to increase pregnancy and birth rates. This study was done to evaluate the reproducibility of previous findings. 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 Na Cl %0.9
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 570 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2006to Jul 2007
- 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 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 long GnRH agonist 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.
Turkey (Türkiye)1 site
Amerikan Hastanesi Tüp Bebek Merkezi
Istanbul, 34365
About this study
A single dose GnRH agonist administration in the luteal phase of assisted reproduction cycles was reported to increase pregnancy and birth rates. This study was done to evaluate the reproducibility of previous findings.
Read the detailed description
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 long GnRH agonist protocol. Women undergoing embryo transfer following controlled ovarian hyperstimulation with a long GnRH agonist 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, Na Cl %0.9
- Keywords
- GnRH agonist, IVF/ICSI outcome, 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
Also called Decapeptyl Ferring GmBH Kiel Germany
Single dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer
Na Cl %0.9Drug
Also called Isotonik NaCl %0.09 Eczacibasi-Baxter Istanbul Turkey
0.1 ml sterile saline subcutaneous injection on the 3rd day after embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | GnRH agonist administration Receives: Drug: triptorelin acetate |
| 2 | Placebo comparator | Sterile saline injection Receives: Drug: Na Cl %0.9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate beyond 20 weeks
Secondary outcomes (2)
Clinical pregnancy
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 posted15 Aug 2007 (estimated)
- Study startSep 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- V.K.V. American Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Investigators
- Baris Ata, M.D., Principal investigator, The Assisted Reproduction Unit of the American Hospital of IstanbulBulent Urman, M.D., Study director, The Assisted Reproduction Unit of the American Hospital of Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00516490
- Sponsor's protocol ID
- AH-47/07
- Status last verified
- Aug 2007
- First submitted
- 14 Aug 2007
- Last updated
- 15 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Tesarik J, Hazout A, Mendoza-Tesarik R, Mendoza N, Mendoza C. Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles. Hum Reprod. 2006 Oct;21(10):2572-9. doi: 10.1093/humrep/del173. Epub 2006 Aug 22.
PubMed 16926261Ata B, Yakin K, Balaban B, Urman B. GnRH agonist protocol administration in the luteal phase in ICSI-ET cycles stimulated with the long GnRH agonist protocol: a randomized, controlled double blind study. Hum Reprod. 2008 Mar;23(3):668-73. doi: 10.1093/humrep/dem421. Epub 2008 Jan 12.
PubMed 18192671
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GnRH Agonist Administration in the Luteal Phase of ICSI-ET Cycles
- ClinicalTrials.gov ID
- NCT00516490
- Acronym / sponsor ID
- AH-47/07
- Conditions
- Infertility
- Keywords
- GnRH agonist, IVF/ICSI outcome, luteal phase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- V.K.V. American Hospital, IstanbulUniversity, hospital or other
- Study start
- Sep 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 15 Aug 2007 (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.
A single dose GnRH agonist administration in the luteal phase of assisted reproduction cycles was reported to increase pregnancy and birth rates. This study was done to evaluate the reproducibility of previous findings.
Detailed description
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 long GnRH agonist protocol. Women undergoing embryo transfer following controlled ovarian hyperstimulation with a long GnRH agonist 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: triptorelin acetateGnRH agonist administration |
| 2 | Placebo comparator | Drug: Na Cl %0.9Sterile saline injection |
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 long GnRH agonist 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 acetateAlso: Decapeptyl Ferring GmBH Kiel GermanySingle dose of 0.1 mg triptorelin subcutaneous injection on the 3rd day after embryo transfer | Drug | 1 |
| Na Cl %0.9Also: Isotonik NaCl %0.09 Eczacibasi-Baxter Istanbul Turkey0.1 ml sterile saline subcutaneous injection on the 3rd day after embryo transfer | Drug | 2 |
Primary outcome
Ongoing pregnancy rate beyond 20 weeks
2 secondary outcomes
Clinical pregnancy
Embryo implantation rate
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 15 Aug 2007.
- Background: PubMed 16926261Tesarik J, Hazout A, Mendoza-Tesarik R, Mendoza N, Mendoza C. Beneficial effect of luteal-phase GnRH agonist administration on embryo implantation after ICSI in both GnRH agonist- and antagonist-treated ovarian stimulation cycles. Hum Reprod. 2006 Oct;21(10):2572-9. doi: 10.1093/humrep/del173. Epub 2006 Aug 22.
- Derived from this study: PubMed 18192671Ata B, Yakin K, Balaban B, Urman B. GnRH agonist protocol administration in the luteal phase in ICSI-ET cycles stimulated with the long GnRH agonist protocol: a randomized, controlled double blind study. Hum Reprod. 2008 Mar;23(3):668-73. doi: 10.1093/humrep/dem421. Epub 2008 Jan 12.
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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.
Baris Ata, M.D. principal investigator
The Assisted Reproduction Unit of the American Hospital of Istanbul
Bulent Urman, M.D. study director
The Assisted Reproduction Unit of the American Hospital of Istanbul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing triptorelin acetate and Na Cl %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: finished, as of the sponsor's last update on 15 Aug 2007. 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.
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?
Ongoing pregnancy rate beyond 20 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00516490, which also lists 2 linked publications.
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 15 Aug 2007.