Oral Dydrogesterone vs. Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Oral Dydrogesterone Versus Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles: a Randomized Controlled Trial

Conditions
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Infertility, Female, Infertility, Male, Embryo Transfer, Fertilization in Vitro, Drug Effect, Reproductive Techniques, Assisted, Progesterone, Dydrogesterone

Intervention / Treatment
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* Drug: Dydrogesterone 10 MG Oral Tablet
* Drug: Progesterone Vaginal Gel [Crinone]


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dydrogesterone<br> | Drug: Dydrogesterone 10 MG Oral Tablet<br>* Oral dydrogesterone 10 mg tablet three times a day for luteal phase support<br>* Other names: Duphaston;|
| Active Comparator: Vaginal progesterone<br> | Drug: Progesterone Vaginal Gel [Crinone]<br>* Vaginal progesterone gel 90 mg once a day for luteal phase support<br>* Other names: Crinone %8 vaginal progesterone gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oral dydrogesterone, luteal phase support, vaginal progesterone gel, frozen-thawed embryo transfer