Frozen Thawed Embryo TransferPhase 4NCT00345306
Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan
A Phase 4 study testing Comparison between two different progesterone administration in people with Frozen Thawed Embryo Transfer, run by Hadassah Medical Organization at 2 sites in Israel.
Trial summary
The transfer of frozen-thawed embryos can be performed in a natural ovulatory cycle or in a hormonally manipulated cycle with a comparable pregnancy rate of 15%-20% per ET. When a hormonally modulated ET cycle is scheduled,an artificial endometrial preparation is carried out using estrogen stimulation followed by a… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Frozen Thawed Embryo Transfer
- What is being tested?
- Comparison between two different progesterone administration
- How many people
- 120 participants
- Where
- 2 sitesIsrael
- Study dates
- Mar 2007to not given
- 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 18 to 35 years
- Women only
- Adult
Who may be able to join
- Patients undergoing frozen thawed ET cycles
- Patient has at least two embryos suitable for transfer after thawing
- Age 18-35 years -
Who cannot join
- Any known sensitivity to Endometrin or Utrogestan
- Endometrial thickness less than 7.5 mm after estrogen priming -
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Hadassah Medical Organization
Jerusalem, 91120
Simon Alex
Jerusalem, 91120
About this study
Official title: Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan - a Clinical Comparative Study
The transfer of frozen-thawed embryos can be performed in a natural ovulatory cycle or in a hormonally manipulated cycle with a comparable pregnancy rate of 15%-20% per ET. When a hormonally modulated ET cycle is scheduled,an artificial endometrial preparation is carried out using estrogen stimulation followed by a concomitant progesterone treatment. Two progestative drugs are currently used in conventional IVF treatment, Utrogetan and Endometrin. Although Endometrin has been be efficiently used to support the luteal phase after embryo transfer in IVF cycles, currently, there is no study that assess its efficacy for clinical use in frozen-thawed ET cycles. The present study aims to compare the outcome of frozen thawed ET cycles when either Endometrin or Utrogestan are used as the progestative substitution in an artificially prepared endometrium.
- Conditions
- Frozen Thawed Embryo Transfer
- Being tested
- Comparison between two different progesterone administration
- Keywords
- endometrial preparation, Utrogestan, Endometrin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison between two different progesterone administrationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rates
Secondary outcomes (1)
Lutheal hormonal profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startMar 2007
Why it stopped: no patient was recruited till 1/2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen Thawed Embryo TransferStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Alex Simon, Principal investigator, Hadassah University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345306
- Sponsor's protocol ID
- EndoUtro-HMO-CTIL
- Status last verified
- Jun 2006
- First submitted
- 27 Jun 2006
- Last updated
- 7 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Endometrial Preparation for Frozen Thawed Embryo Transfer Applying Either Endometrin or Utrogestan - a Clinical Comparative Study
- ClinicalTrials.gov ID
- NCT00345306
- Acronym / sponsor ID
- EndoUtro-HMO-CTIL
- Conditions
- Frozen Thawed Embryo Transfer
- Keywords
- endometrial preparation, Utrogestan, Endometrin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: no patient was recruited till 1/2008
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Mar 2007
- First posted
- 28 Jun 2006 (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 transfer of frozen-thawed embryos can be performed in a natural ovulatory cycle or in a hormonally manipulated cycle with a comparable pregnancy rate of 15%-20% per ET. When a hormonally modulated ET cycle is scheduled,an artificial endometrial preparation is carried out using estrogen stimulation followed by a concomitant progesterone treatment. Two progestative drugs are currently used in conventional IVF treatment, Utrogetan and Endometrin. Although Endometrin has been be efficiently used to support the luteal phase after embryo transfer in IVF cycles, currently, there is no study that assess its efficacy for clinical use in frozen-thawed ET cycles. The present study aims to compare the outcome of frozen thawed ET cycles when either Endometrin or Utrogestan are used as the progestative substitution in an artificially prepared endometrium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients undergoing frozen thawed ET cycles
- Patient has at least two embryos suitable for transfer after thawing
- Age 18-35 years -
Key exclusion criteria (2 listed)
- Any known sensitivity to Endometrin or Utrogestan
- Endometrial thickness less than 7.5 mm after estrogen priming -
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 |
|---|---|---|
| Comparison between two different progesterone administration | Drug | – |
Primary outcome
Pregnancy rates
1 secondary outcome
Lutheal hormonal profile
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2008.
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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.
Alex Simon principal investigator
Hadassah University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Comparison between two different progesterone administration in people with Frozen Thawed Embryo Transfer, run by Hadassah Medical Organization at 2 sites 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 3 inclusion and 2 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: paused, as of the sponsor's last update on 7 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
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?
Pregnancy rates. 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 7 May 2008.