Status:
UNKNOWN
Addition of Dydrogesterone to the Luteal Phase Support After Fresh Embryo Transfer
Lead Sponsor:
Laniado Hospital
Conditions:
Infertility
IVF
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief 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.
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 I...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04408144
Start Date
April 1 2022
End Date
May 31 2023
Last Update
October 4 2021
Active Locations (1)
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1
Laniado Hospital
Netanya, Israel