Clinical Research Details

Descriptive Information
Oral dydrogesterone versus vaginal progesterone in the luteal phase support in cryo-warmed embryo transfer cycles: Randomized Controlled Trial

Johnny Awwad
jawwad@aub.edu.lb

BIO-2017-0542
Recruiting

Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 2  

No
Coordinators
Layal Hamdar
lh72@aub.edu.lb
Extension: 5606
Conditions and Keywords
Infertility
IVF,luteal phase support,cryo-warmed embryo transfer
Study Design
Treatment
N/A: Not Applicable
Prospective
N/A: Not Applicable
Randomized
Eligibility and IRB
Female
Min: 18
Max: 42
Yes
No

In IVF/ICSI cycles, the progesterone levels induced by ovarian stimulation are low; therefore the luteal phase is supported by progesterone. The routes of progesterone supplements could be oral, vaginal, rectal or intramuscular. Currently vaginal progesterone is widely used, since the classic oral progesterone seems to result in a low bioavailability and a lower pregnancy rate. Not to mention that the intramuscular progesterone daily injections are painful and may cause abscesses, inflammatory reactions. Meanwhile, vaginal administration of progesterone is associated with vaginal irritation, discharge and bleeding. Therefore, there is a need for an effective, well tolerated, and safe treatment that can improve patient satisfaction and compliance. 

This is a prospective comparative randomized controlled trial investigating 224 patients who are seeking IVF/ICSI fertility treatment at AUBMC Fertility Center at American University of Beirut Medical Center. We aim to demonstrate the superiority of oral dydrogesterone (Duphaston) 10 over micronized vaginal progesterone (Utrogestan) used for luteal supplementation in cryo-warmed embryo transfer cycles


This is a prospective comparative randomized controlled trial investigating 224 patients who are seeking IVF/ICSI fertility treatment at AUBMC Fertility Center at American University of Beirut Medical Center.




Age: 18- 42

Undergoing a cryo-warmed embryo transfer

Normal uterine cavity

Normal hormonal investigation: TSH, PRL

 Body mass index (BMI) ≥18 to ≤30 kg/m2



  History of three or more miscarriages

 History of three or more previous IVF failures

  Abnormal uterine cavity (Hysteroscopy or HSG)

  Previous allergy reactions to progesterone products

Preexisting untreated medical condition (thyroid disease, diabetes mellitus, hypertension, pulmonary conditions, cardiac condition…).