ARTNCT03832699
Oral Dydrogesterone vs. Vaginal Micronized Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer
A study testing Dydrogesterone 10 MG and Endometrin 100Mg Vaginal Insert in people with ART, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
The current trial is intended to assess the efficacy of oral versus vaginal progesterone for luteal support in frozen IVF cycles. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- ART
- What is being tested?
- Dydrogesterone 10 MG and Endometrin 100Mg Vaginal Insert
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Mar 2019to Oct 2021
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-39
- Modified natural cycle (induction of ovulation with HCG)
- Consent to participation
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Edith Wolfson Medical Center
Holon, 5822012
Hadas Ganer Herman, MD, 9720526206696, hadassganer@yahoo.com
About this study
Official title: Oral Dydrogesterone vs. Vaginal Micronized Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer: a Non-inferiority Randomized Clinical Trial
The current trial is intended to assess the efficacy of oral versus vaginal progesterone for luteal support in frozen IVF cycles.
Read the detailed description
Progesteron is used for luteal phase support in IVF cycles. Progesterone can be administered vaginally and orally. Duphaston is an oral progesterone drug, which has recentlly been proven effective in fresh cycle IVF. Yet, less is known regarding its efficacy in frozen cycle IVF. Thus, the objective of our trial is to compare the efficacy of vaginal and oral progesterone in frozen IVF cycles.
- Conditions
- ART
- Being tested
- Dydrogesterone 10 MG, Endometrin 100Mg Vaginal Insert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dydrogesterone 10 MGDrug
Oral progesterone 10 mg TID
Endometrin 100Mg Vaginal InsertDrug
Vaginal Endometrin 100 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| Oral progesterone | Experimental | Not described Receives: Drug: Dydrogesterone 10 MG |
| Vaginal progesterone | Active comparator | Not described Receives: Drug: Endometrin 100Mg Vaginal Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Birth of a live infant after 24 weeks gestation
Measured: Up to 9 months
Secondary outcomes (2)
Clinical pregnancy rate
Viable pregnancy as demonstrated by ultrasound
Measured: Outcome assesed 6-7 weeks following treatment
Implantation rate
Number of gestational sacs divided by number of embryos transferred (percentage)
Measured: Outcome assessed 6-7 weeks following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start1 Mar 2019
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARTStudies 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hadas Ganer Herman, Wolfson Medical Center
- Investigators
- Hadas Ganer Herman, MD, Principal investigator, Edith Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832699
- Sponsor's protocol ID
- 0013-19-WOMC
- Status last verified
- Oct 2020
- First submitted
- 5 Feb 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Dydrogesterone vs. Vaginal Micronized Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer: a Non-inferiority Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03832699
- Acronym / sponsor ID
- 0013-19-WOMC
- Conditions
- ART
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 6 Feb 2019 (actual)
- 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 current trial is intended to assess the efficacy of oral versus vaginal progesterone for luteal support in frozen IVF cycles.
Detailed description
Progesteron is used for luteal phase support in IVF cycles. Progesterone can be administered vaginally and orally. Duphaston is an oral progesterone drug, which has recentlly been proven effective in fresh cycle IVF. Yet, less is known regarding its efficacy in frozen cycle IVF. Thus, the objective of our trial is to compare the efficacy of vaginal and oral progesterone in frozen IVF cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral progesterone | Experimental | Drug: Dydrogesterone 10 MG |
| Vaginal progesterone | Active comparator | Drug: Endometrin 100Mg Vaginal Insert |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages 18-39
- Modified natural cycle (induction of ovulation with HCG)
- Consent to participation
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Dydrogesterone 10 MGOral progesterone 10 mg TID | Drug | Oral progesterone |
| Endometrin 100Mg Vaginal InsertVaginal Endometrin 100 mg twice daily | Drug | Vaginal progesterone |
Primary outcome
Live birth rate
Time frame: Up to 9 months
Birth of a live infant after 24 weeks gestation
2 secondary outcomes
Clinical pregnancy rate
Time frame: Outcome assesed 6-7 weeks following treatment
Implantation rate
Time frame: Outcome assessed 6-7 weeks following treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
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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.
Hadas Ganer Herman, MD principal investigator
Edith Wolfson Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dydrogesterone 10 MG and Endometrin 100Mg Vaginal Insert in people with ART, 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 3 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 8 Oct 2020. 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 Hadas Ganer Herman, MD (972526206696, hadassganer@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate (time frame: Up to 9 months). 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 8 Oct 2020.