Infertility, Female, Infertility, Male, Embryo Transfer, Fertilization in Vitro, Drug Effect, Reproductive Techniques, Assisted, Progesterone, Dydrogesterone
Conditions
Keywords
oral dydrogesterone, luteal phase support, vaginal progesterone gel, frozen-thawed embryo transfer
Brief summary
The aim of this randomized controlled trial is to compare the efficacy of oral dydrogesterone vs. micronized vaginal progesterone for luteal phase support in frozen-thawed embryo transfer cycles.
Interventions
Oral dydrogesterone 10 mg tablet three times a day for luteal phase support
DRUGProgesterone Vaginal Gel [Crinone]
Vaginal progesterone gel 90 mg once a day for luteal phase support
Sponsors
Memorial Sisli Hospital, Istanbul
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Ages between 20 and 40 * Modified natural frozen- thawed embryo transfer cycles
Exclusion criteria
* Recurrent implantation failure * Recurrent pregnancy loss * Presence of uterine pathology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | 12 weeks after the last menstrual period of the patient | Presence of at least one live fetus at the end of the 12th gestational week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implantation rate | 5 weeks after the last menstrual period of the patient | Percentage of gestational sacs compared to the number of embryos transferred |
| Biochemical pregnancy | 10 days after embryo transfer | Positive serum beta HCG test performed 10 days after embryo transfer |
| Biochemical miscarriage | before 5th gestational week | pregnancy loss before ultrasonographic detection of an intrauterine gestational sac |
| Clinical miscarriage | after 5th gestational week | pregnancy loss after ultrasonographic detection of an intrauterine gestational sac |
| headache rate | 6-7 weeks after the last menstrual period of the patient | — |
| interference with coitus rate | 6-7 weeks after the last menstrual period of the patient | — |
| somnolence rate | 6-7 weeks after the last menstrual period of the patient | — |
| dizziness rate | 6-7 weeks after the last menstrual period of the patient | — |
| Clinical pregnancy rate | 6-7 weeks after the last menstrual period of the patient | Presence of an intrauterine gestational sac with fetal heart beat at 7th week of gestation |
| vaginal discharge rate | 6-7 weeks after the last menstrual period of the patient | — |
| perineal irritation rate | 6-7 weeks after the last menstrual period of the patient | — |
| abdominal pain rate | 6-7 weeks after the last menstrual period of the patient | — |
| mastalgia rate | 6-7 weeks after the last menstrual period of the patient | — |
| vaginal bleeding rate | 6-7 weeks after the last menstrual period of the patient | — |
| interference with intercourse rate | 6-7 weeks after the last menstrual period of the patient | — |
| overall satisfaction score | 6-7 weeks after the last menstrual period of the patient | patient satisfaction from the drug used measured on a 1-5 scale |
| nausea/vomiting rate | 6-7 weeks after the last menstrual period of the patient | — |
Countries
Turkey (Türkiye)
Contacts
Primary ContactGonul Ozer, MD
Backup ContactKadriye B Yuksel, MD
Outcome results
None listed