Addition of Dydrogesterone to the Luteal Phase Support After Fresh Embryo Transfer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Treatment With Additional Dydrogesterone (Duphaston) to the Standard Luteal Phase Support After Fresh Embryo Transfer: a Prospective Randomized Controlled Trial.

Conditions
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Infertility, IVF

Intervention / Treatment
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* Drug: Dydrogesterone 10mg Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: StudyGroup<br>Patients will receive an addition of dydrogesterone (Duphaston) to the standard treatment for luteal phase support | Drug: Dydrogesterone 10mg Oral Tablet<br>* oral 10mg dydrogesterone (Duphaston) 2 times daily<br>|
| No Intervention: Control Group<br>Patients will receive the standard treatment for luteal phase support without Dydrogesterone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live birth rate | The percentage of live newborns in the total cycles of treatment | 9 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 weeks | 
| Frequency of positive pregnancy tests on Day 14 after embryo transfer |  | 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 | 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. | 1 year | 
| Newborn Weight | in grammes | 9 months | 
| Rates of Newborn malformations | Abnormal findings of physical examination of the newborn | 1 year |