Infertility, Sterility
Conditions
Keywords
Luteal Phase Support, Cryo-warmed Embryo Transfer, Assisted Reproductive Technology
Brief summary
In IVF/ICSI cycles, the progesterone levels induced by ovarian stimulation are low, therefore the luteal phase is supported by progesterone. The use of progestogens in IVF is associated with an improvement in the live birth rate Standard protocol for luteal phase support has not yet been established. Currently vaginal progesterone is widely used, since the classic oral progesterone seems to result in a low bioavailability and a lower pregnancy rate. However, vaginal administration of progesterone is associated with vaginal irritation, discharge and bleeding. For all these reasons, there is a need for an effective, well tolerated, and safe treatment that can improve patient satisfaction and compliance. Many studies have observed similar pregnancy rate results with dydrogesterone and micronized vaginal progesterone. A new RCT including a total of 1143 patients by Tournaye, showed that dydrogesterone treatment had a similar safety profile to micronized vaginal progesterone (MVP) for luteal support as part of ART treatment. The crude pregnancy rates at 12 weeks were 37.6% and 33.1% in the dydrogesterone and MVP treatment groups respectively. Regarding the administration route of progesterone, intramuscular and transvaginal routes are the two conventional progesterone administration techniques. However, very few studies have compared the advantages of oral dydrogestrone with vaginal progesterone for luteal support in ART cycles. The objective of the investigator's study is to demonstrate the superiority of oral dydrogesterone (Duphaston) 10 over MVP (Utrogestan) used for luteal supplementation in cryo-warmed embryo transfer cycles. Upon consent, 224 patients women will be randomly allocated into either one of the study groups using a simple randomization method by computer-generated random numbers. Group I will receive the oral dydrogesterone, while group II will receive the vaginal microprogesterone.
Interventions
DRUGProgesterone
Patients will be randomly assigned during the treatment follow up, at the time of addition of progesterone to the regimen, following computerized random number generator in procedure, to one of the study groups. Patients will be aware of the allocated arm since the treatment drugs have different route of administration. Group I will receive the oral dydrogesterone, while group II will receive the vaginal microprogesterone.
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
* Normal uterine cavity * Normal Hormonal investigation: TSH,PRL,FBS * Frozen embryo transfer cycles: at least 2 embryos * Primary or secondary infertility: tubal occlusion, male factor, unexplained, endometriosis, ovarian factors… * Body mass index (BMI) ≥18 to ≤30 kg/m2
Exclusion criteria
* Preexisting untreated medical condition (thyroid disease, diabetes mellitus, hypertension, pulmonary conditions, cardiac condition…) * History of three or more consecutively failed In Vitro Fertilization (IVF) cycles after embryo transfer * History of three or more miscarriages * Previous allergy reactions to progesterone products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Live births per embryo transferred | until date of delivery | Number of live births per number of embryos transferred |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing or Clinical pregnancy rate per started treatment cycle (CPR) | 20 weeks from Last Menstrual Period (LMP) | The presence of a viable fetus at 20 weeks gestation or fetal heart beat on transvaginal ultrasound after 6-7 weeks of gestation |
| Implantation rate (IR) | 7 weeks from LMP | Number of intrauterine gestational sacs observed on transvaginal ultrasound divided by the number of transferred embryos |
| Miscarriage rates | From a positive pregnancy test till 12 weeks gestation | Pregnancy loss prior to 12 weeks of gestation |
| Multiple gestation rate | 6-7 weeks of gestation | More than one intra-uterine gestation sac at 6 weeks of gestation |
Countries
Lebanon
Outcome results
None listed