Abnormal Menstrual CycleEarly Phase 1NCT01483365
The Need for Luteal Support in NC-FET
A Early Phase 1 study testing Vaginal tablet Endometrin twice a day in people with Abnormal Menstrual Cycle, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
The investigators are going to examine prospectively the need of luteal support after NC-FET. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Abnormal Menstrual Cycle
- What is being tested?
- Vaginal tablet Endometrin twice a day
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2011to Dec 2014
- Phase
- Early Phase 1
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women under 39 years old, regular menstruation going through IVF NC-FET
Who cannot join
- NO
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Wolfson medical center
Holon, 58100
Eran Horowitz, M.D, 972-3-5028105, eranh7@gmail.com
Eran Horowitz, M.D
About this study
Official title: The Use of Luteal Support After NC-FET
The investigators are going to examine prospectively the need of luteal support after NC-FET.
Read the detailed description
The investigators are going to examine retroprospectively the need of luteal support after NC-FET in IVF cycle. One arm will receive luteal support after NC FET with vaginal tablet of Endometrin 100 mg twice a day after ET. The second arm will not. We are going to evaluate the pregnancy and implantation rate.
- Conditions
- Abnormal Menstrual Cycle
- Being tested
- Vaginal tablet Endometrin twice a day
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal tablet Endometrin twice a dayDrug
Also called Endometrin 100 mg twice a day
Endometrin 100 mg twice a day
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
We would like to investigate whether there is need for luteal support in NC-FET cycle.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (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 Abnormal Menstrual CycleStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- David Levran, M.D, Principal investigator, IVF Unit, Department of Obstetrics and Gynecology,Wolfson Medical Center . Holon, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483365
- Sponsor's protocol ID
- 0087-11-WOMC-
- Status last verified
- Jun 2014
- First submitted
- 29 Nov 2011
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Horowitz E, Mizrachi Y, Finkelstein M, Farhi J, Shalev A, Gold E, Raziel A, Weissman A. A randomized controlled trial of vaginal progesterone for luteal phase support in modified natural cycle - frozen embryo transfer. Gynecol Endocrinol. 2021 Sep;37(9):792-797. doi: 10.1080/09513590.2020.1854717. Epub 2020 Dec 14.
PubMed 33307906
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Luteal Support After NC-FET
- ClinicalTrials.gov ID
- NCT01483365
- Acronym / sponsor ID
- 0087-11-WOMC-
- Conditions
- Abnormal Menstrual Cycle
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Dec 2011
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 1 Dec 2011 (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 investigators are going to examine prospectively the need of luteal support after NC-FET.
Detailed description
The investigators are going to examine retroprospectively the need of luteal support after NC-FET in IVF cycle. One arm will receive luteal support after NC FET with vaginal tablet of Endometrin 100 mg twice a day after ET. The second arm will not. We are going to evaluate the pregnancy and implantation rate.
Study design
- Primary purpose
- Supportive care
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women under 39 years old, regular menstruation going through IVF NC-FET
Key exclusion criteria (1 listed)
- NO
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 |
|---|---|---|
| Vaginal tablet Endometrin twice a dayAlso: Endometrin 100 mg twice a dayEndometrin 100 mg twice a day | Drug | – |
Primary outcome
Pregnancy rate
Time frame: 4 weeks
We would like to investigate whether there is need for luteal support in NC-FET cycle.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
- Derived from this study: PubMed 33307906Horowitz E, Mizrachi Y, Finkelstein M, Farhi J, Shalev A, Gold E, Raziel A, Weissman A. A randomized controlled trial of vaginal progesterone for luteal phase support in modified natural cycle - frozen embryo transfer. Gynecol Endocrinol. 2021 Sep;37(9):792-797. doi: 10.1080/09513590.2020.1854717. Epub 2020 Dec 14.
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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.
David Levran, M.D principal investigator
IVF Unit, Department of Obstetrics and Gynecology,Wolfson Medical Center . Holon, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Vaginal tablet Endometrin twice a day in people with Abnormal Menstrual Cycle, run by Wolfson 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 1 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 17 Jun 2014. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Contact Eran Horowitz, M.D (972-3-5028105, ERANH7@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy rate (time frame: 4 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 NCT01483365, 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 17 Jun 2014.