An interventional study of Dydrogesterone 10mg Oral Tablet in Infertility and IVF, sponsored by Laniado Hospital. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-04.
Sponsored by Laniado Hospital · Not applicable, Interventional, and Treatment
Randomized controlled study, open label to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer.
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.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 300 is above the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Laniado Hospital is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive an addition of dydrogesterone (Duphaston) to the standard treatment for luteal phase support
Drug: Dydrogesterone 10mg Oral Tablet
Patients will receive the standard treatment for luteal phase support without Dydrogesterone
oral 10mg dydrogesterone (Duphaston) 2 times daily
Live birth rate
The percentage of live newborns in the total cycles of treatment
Time frame: 9 month
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
Time frame: 12 weeks
Frequency of positive pregnancy tests on Day 14 after embryo transfer
Time frame: 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
Time frame: 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.
Time frame: 1 year
Newborn Weight
in grammes
Time frame: 9 months
Rates of Newborn malformations
Abnormal findings of physical examination of the newborn
Time frame: 1 year
Incidence of Treatment-Emergent Adverse Events
Adverse Events (AES) and Serious Adverse Events (SAES) will be recorded during all the study period
Time frame: 3 years
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dydrogesterone
Laniado Hospital