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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dydrogesterone | Experimental |
| |
| Vaginal progesterone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dydrogesterone 10 MG Oral Tablet | Drug | Oral dydrogesterone 10 mg tablet three times a day for luteal phase support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing pregnancy rate | Presence of at least one live fetus at the end of the 12th gestational week | 12 weeks after the last menstrual period of the patient |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy rate | Presence of an intrauterine gestational sac with fetal heart beat at 7th week of gestation | 6-7 weeks after the last menstrual period of the patient |
| Implantation rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gonul Ozer, MD | Contact | +905326945549 | drgonulozer@gmail.com | |
| Kadriye B Yuksel, MD | Contact | +905438852666 | berilyuksel@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Semra Kahraman, Prof | Memorial Şişli Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Şişli Hospital | Recruiting | Istanbul | Şişli | 34385 | Turkey (Türkiye) |
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Randomized controlled trial
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| Progesterone Vaginal Gel [Crinone] | Drug | Vaginal progesterone gel 90 mg once a day for luteal phase support |
|
|
Percentage of gestational sacs compared to the number of embryos transferred
| 5 weeks after the last menstrual period of the patient |
| Biochemical pregnancy | Positive serum beta HCG test performed 10 days after embryo transfer | 10 days after embryo transfer |
| Biochemical miscarriage | pregnancy loss before ultrasonographic detection of an intrauterine gestational sac | before 5th gestational week |
| Clinical miscarriage | pregnancy loss after ultrasonographic detection of an intrauterine gestational sac | after 5th gestational week |
| 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 |
| nausea/vomiting rate | 6-7 weeks after the last menstrual period of the patient |
| 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 | patient satisfaction from the drug used measured on a 1-5 scale | 6-7 weeks after the last menstrual period of the patient |
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D007248 | Infertility, Male |
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D007246 | Infertility |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D004394 | Dydrogesterone |
| D013607 | Tablets |
| C400424 | Crinone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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