Pregnancy RateNCT00542126
Luteal-Phase GnRH Agonist Administration in Frozen-Thawed IVF Embryo Transfer Cycles
A study testing Decapeptyl 0.1 mg after embryo transfer in people with Pregnancy Rate, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Supraphysiological hormonal stimulation enables collecting many oocytes in an In-Vitro Fertilization treatment, but may have a negative effect on uterine function and contribute the fact that the majority of preembryos placed in the uterus fail to implant. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Pregnancy Rate
- What is being tested?
- Decapeptyl 0.1 mg after embryo transfer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Dec 2007to Sep 2009
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- IVF patients transfer of a minimum of two medium-quality thawed embryos in IVF
Who cannot join
- Two or more fresh IVF embryo transfer or three or more thawed embryos transfer with no pregnancy.
- maximal endometrial thickness < 6 mm or intracavitary fluid at the time of embryo transfer on previous cycles
- Untreated hydrosalpinges
- intracavitary mass
- submucous myoma
- known allergy to one of medical agents used in the study
Trial locations and contacts
1 site in 1 country.
Ehud Margalioth, MD contact
Israel1 site
IVF unit, Shaare-Zedek Medical Center
Jerusalem, 91031
Avi Tsafrir, MD, 972-508573805, avits@szmc.org.il
Avi Tsafrir, MD
About this study
Supraphysiological hormonal stimulation enables collecting many oocytes in an In-Vitro Fertilization treatment, but may have a negative effect on uterine function and contribute the fact that the majority of preembryos placed in the uterus fail to implant.
Several medical agents were shown to be beneficial when given in the luteal phase of an IVF cycle, but the optimal regimen has not been yet determined. In 2006, a European group reported that addition of GnRH analog (Decapeptyl) as luteal support in IVF cycle significantly improved pregnancy and delivery rates. It is not known whether this positive effect influences the corpus luteum, embryo or the uterus. The researchers sought to evaluate the effect of GnRH administration as luteal support in frozen-thaws IVF cycle.
- Conditions
- Pregnancy Rate
- Being tested
- Decapeptyl 0.1 mg after embryo transfer
- Keywords
- GnRH analog, IVF, infertility, frozen-thawed embryos
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decapeptyl 0.1 mg after embryo transferDrug
Decapeptyl 0.1 mg (Ferring, Kiel, Germany) 3 days following embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | GnRH analog administration following embryo transfer Receives: Drug: Decapeptyl 0.1 mg after embryo transfer |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy and delivery rates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startDec 2007
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RateStudies 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
- None (open label)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Avi Tsafrir, MD, Principal investigator, Shaare-Zedek Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542126
- Sponsor's protocol ID
- GnRHFETsupport.CTIL
- Status last verified
- Sep 2007
- First submitted
- 19 Sep 2007
- Last updated
- 10 Oct 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 16926261
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Luteal-Phase GnRH Agonist Administration in Frozen-Thawed IVF Embryo Transfer Cycles
- ClinicalTrials.gov ID
- NCT00542126
- Acronym / sponsor ID
- GnRHFETsupport.CTIL
- Conditions
- Pregnancy Rate
- Keywords
- GnRH analog, IVF, infertility, frozen-thawed embryos
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Dec 2007
- Study completion
- Sep 2009 (estimated)
- First posted
- 10 Oct 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.
Supraphysiological hormonal stimulation enables collecting many oocytes in an In-Vitro Fertilization treatment, but may have a negative effect on uterine function and contribute the fact that the majority of preembryos placed in the uterus fail to implant.
Several medical agents were shown to be beneficial when given in the luteal phase of an IVF cycle, but the optimal regimen has not been yet determined. In 2006, a European group reported that addition of GnRH analog (Decapeptyl) as luteal support in IVF cycle significantly improved pregnancy and delivery rates. It is not known whether this positive effect influences the corpus luteum, embryo or the uterus. The researchers sought to evaluate the effect of GnRH administration as luteal support in frozen-thaws IVF cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Decapeptyl 0.1 mg after embryo transferGnRH analog administration following embryo transfer |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- IVF patients transfer of a minimum of two medium-quality thawed embryos in IVF
Key exclusion criteria (6 listed)
- Two or more fresh IVF embryo transfer or three or more thawed embryos transfer with no pregnancy.
- maximal endometrial thickness < 6 mm or intracavitary fluid at the time of embryo transfer on previous cycles
- Untreated hydrosalpinges
- intracavitary mass
- submucous myoma
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 |
|---|---|---|
| Decapeptyl 0.1 mg after embryo transferDecapeptyl 0.1 mg (Ferring, Kiel, Germany) 3 days following embryo transfer | Drug | 1 |
Primary outcome
pregnancy and delivery rates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 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.
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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.
Ehud Margalioth, MD contact
Avi Tsafrir, MD principal investigator
Shaare-Zedek Medical Center, Jerusalem, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decapeptyl 0.1 mg after embryo transfer in people with Pregnancy Rate, run by Shaare Zedek Medical Center at 1 site in Israel.
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 6 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 10 Oct 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 Israel. 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.
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 Avi Tsafrir, MD (972-508573805, avits@scmz.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy and delivery rates. 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 NCT00542126, which also lists 1 linked publication.
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 10 Oct 2007.