InfertilityNCT04408144
Addition of Dydrogesterone to the Luteal Phase Support After Fresh Embryo Transfer
A study testing Dydrogesterone 10mg Oral Tablet in people with Infertility and IVF, run by Laniado Hospital at 1 site in Israel.
Trial summary
Randomized controlled study, open label to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, IVF
- What is being tested?
- Dydrogesterone 10mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Apr 2022to 31 May 2023
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with a documented history of infertility who underwent IVF with or without ICSI, going through embryos transfer (having in the past up to 2 previous embryos transfer) and who gave written informed consent.
- Body mass index ≥18 to ≤35 kg/m2
- LH, prolactin (PRL), testosterone and thyroid-stimulating hormone (TSH) within normal clinical limits or not considered clinically significant within 1 year prior to or at screening
- Normal transvaginal ultrasound at screening (or within 14 days prior to screening)
- Planning a transfer of 1 or 2 fresh embryos.
Who cannot join
- Previous participation in this trial
- Subjects with >2 unsuccessful IVF attempts
- Evidence of head, ear, eye, nose, throat, cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine or neurologic/psychiatric disorders;
- Recent major surgery (within 3 months);
- Current or recent substance abuse, including that of alcohol and tobacco;
- History of chemotherapy;
- History of recurrent pregnancy loss (≥3 previous miscarriages)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Treatment With Additional Dydrogesterone (Duphaston) to the Standard Luteal Phase Support After Fresh Embryo Transfer: a Prospective Randomized Controlled Trial.
Randomized controlled study, open label to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer.
Read the detailed description
In the context of IVF treatment, it's a standard of care to use progesterone for endometrial synchronization and for luteal phase support after embryos transfer and until week 9-12 of pregnancy.
In Israel, as in most european countries, vaginal insert of Micronised Vaginal Progesterone (MVP) is mostly prescribed.
Dydrogesterone is a potent active progesterone receptor agonist that is well tolerated, orally administered and is considered to be sufficiently safe during pregnancy.
Based on recent publications, single oral dydrogesterone treatment seems to be a good option in clinical practice for luteal phase support in IVF cycles with fresh embryos transfer.
But, until now, there is no publication evaluating the effectiveness of an addition of Dydrogesterone to the standard of care.
The aim of the study is to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer.
The trial is a randomized controlled study, open label. Participants will receive either standard treatment with an addition of oral 10mg dydrogesterone (Duphaston) 2 times daily or the standard treatment without Dydrogesterone, starting on the day of fresh embryos transfer until 10 weeks of gestation or until pregnancy test is negative.
Study participation will be proposed to every woman going through fresh embryos transfer in Laniado IVF unit, who meets the inclusion/exclusion criteria.
The investigators aim to include 150 patients in each arm of the study, during 2 years.
- Conditions
- Infertility, IVF
- Being tested
- Dydrogesterone 10mg Oral Tablet
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dydrogesterone 10mg Oral TabletDrug
oral 10mg dydrogesterone (Duphaston) 2 times daily
| Study group | Role | What they receive |
|---|---|---|
| StudyGroup | Experimental | Patients will receive an addition of dydrogesterone (Duphaston) to the standard treatment for luteal phase support Receives: Drug: Dydrogesterone 10mg Oral Tablet |
| Control Group | No intervention | Patients will receive the standard treatment for luteal phase support without Dydrogesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
The percentage of live newborns in the total cycles of treatment
Measured: 9 month
Secondary outcomes (6)
Presence of fetal heartbeats at 12 weeks of gestation
The percentage of pregnancies with heartbeats observed by ultrasound at 12 weeks in the total cycles of treatment
Measured: 12 weeks
Frequency of positive pregnancy tests on Day 14 after embryo transfer
Measured: 14 days
Rates of obstetrical complications
Obstetrical complications during pregnancy and labor. Examples- abruptio placenta, First trimester bleeding, Preterm Prelabor Rupture Of Membranes (PPROM), preterm labor
Measured: 9 months
Newborn outcomes
Appearance, Pulse, Grimace, Activity and Respiration (APGAR) score- between 0-10. 10 is the best outcome. 0 is the worst outcome.
Measured: 1 year
Newborn Weight
in grammes
Measured: 9 months
Rates of Newborn malformations
Abnormal findings of physical examination of the newborn
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start1 Apr 2022 (estimated)
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laniado Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Weintraub, Laniado Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04408144
- Sponsor's protocol ID
- 0003-20-LND
- Status last verified
- Sep 2021
- First submitted
- 12 May 2020
- Last updated
- 4 Oct 2021
- 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 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Treatment With Additional Dydrogesterone (Duphaston) to the Standard Luteal Phase Support After Fresh Embryo Transfer: a Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04408144
- Acronym / sponsor ID
- 0003-20-LND
- Conditions
- Infertility, IVF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Laniado HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 29 May 2020 (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.
Randomized controlled study, open label to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer.
Detailed description
In the context of IVF treatment, it's a standard of care to use progesterone for endometrial synchronization and for luteal phase support after embryos transfer and until week 9-12 of pregnancy.
In Israel, as in most european countries, vaginal insert of Micronised Vaginal Progesterone (MVP) is mostly prescribed.
Dydrogesterone is a potent active progesterone receptor agonist that is well tolerated, orally administered and is considered to be sufficiently safe during pregnancy.
Based on recent publications, single oral dydrogesterone treatment seems to be a good option in clinical practice for luteal phase support in IVF cycles with fresh embryos transfer.
But, until now, there is no publication evaluating the effectiveness of an addition of Dydrogesterone to the standard of care.
The aim of the study is to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer.
The trial is a randomized controlled study, open label. Participants will receive either standard treatment with an addition of oral 10mg dydrogesterone (Duphaston) 2 times daily or the standard treatment without Dydrogesterone, starting on the day of fresh embryos transfer until 10 weeks of gestation or until pregnancy test is negative.
Study participation will be proposed to every woman going through fresh embryos transfer in Laniado IVF unit, who meets the inclusion/exclusion criteria.
The investigators aim to include 150 patients in each arm of the study, during 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| StudyGroup | Experimental | Drug: Dydrogesterone 10mg Oral TabletPatients will receive an addition of dydrogesterone (Duphaston) to the standard treatment for luteal phase support |
| Control Group | No intervention | –Patients will receive the standard treatment for luteal phase support without Dydrogesterone |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with a documented history of infertility who underwent IVF with or without ICSI, going through embryos transfer (having in the past up to 2 previous embryos transfer) and who gave written informed consent.
- Body mass index ≥18 to ≤35 kg/m2
- LH, prolactin (PRL), testosterone and thyroid-stimulating hormone (TSH) within normal clinical limits or not considered clinically significant within 1 year prior to or at screening
- Normal transvaginal ultrasound at screening (or within 14 days prior to screening)
- Planning a transfer of 1 or 2 fresh embryos.
Key exclusion criteria (7 listed)
- Previous participation in this trial
- Subjects with >2 unsuccessful IVF attempts
- Evidence of head, ear, eye, nose, throat, cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, dermatologic/connective tissue, musculoskeletal, metabolic/nutritional, endocrine or neurologic/psychiatric disorders;
- Recent major surgery (within 3 months);
- Current or recent substance abuse, including that of alcohol and tobacco;
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 10mg Oral Tabletoral 10mg dydrogesterone (Duphaston) 2 times daily | Drug | StudyGroup |
Primary outcome
Live birth rate
Time frame: 9 month
The percentage of live newborns in the total cycles of treatment
6 secondary outcomes
Presence of fetal heartbeats at 12 weeks of gestation
Time frame: 12 weeks
Frequency of positive pregnancy tests on Day 14 after embryo transfer
Time frame: 14 days
Rates of obstetrical complications
Time frame: 9 months
Newborn outcomes
Time frame: 1 year
Newborn Weight
Time frame: 9 months
Rates of Newborn malformations
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 10mg Oral Tablet in people with Infertility and IVF, run by Laniado Hospital 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 5 inclusion and 7 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 4 Oct 2021. 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?
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?
Live birth rate (time frame: 9 month). 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 4 Oct 2021.