Clinical trial NCT04124913: Oral Dydrogesterone vs. Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles
Official title: Comparison of Oral Dydrogesterone Versus Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility, Female
Infertility, Male
Embryo Transfer
Fertilization in Vitro
Drug Effect
Reproductive Techniques, Assisted
Progesterone
Dydrogesterone
Keywords: oral dydrogesterone
luteal phase support
vaginal progesterone gel
frozen-thawed embryo transfer
Lead sponsor: Memorial Sisli Hospital, Istanbul
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 140
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 12 weeks after the last menstrual period of the patient
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 6-7 weeks after the last menstrual period of the patient
measure: Implantation rate
timeFrame: 5 weeks after the last menstrual period of the patient
measure: Biochemical pregnancy
timeFrame: 10 days after embryo transfer
measure: Biochemical miscarriage
timeFrame: before 5th gestational week
measure: Clinical miscarriage
timeFrame: after 5th gestational week
measure: headache rate
timeFrame: 6-7 weeks after the last menstrual period of the patient
measure: interference with coitus rate
timeFrame: 6-7 weeks after the last menstrual period of the patient
measure: somnolence rate
timeFrame: 6-7 weeks after the last menstrual period of the patient
measure: dizziness rate
timeFrame: 6-7 weeks after the last menstrual period of the patient
measure: nausea/vomiting rate
timeFrame: 6-7 weeks after the last menstrual period of the patient
measure: vaginal discharge rate
timeFrame: 6-7 weeks after the last menstrual period of the patient
measure: perineal irritation rate
timeFrame: 6-7 weeks after the last menstrual period of the patient
measure: abdominal pain rate
timeFrame: 6-7 weeks after the last menstrual period of the patient
measure: mastalgia rate
timeFrame: 6-7 weeks after the last menstrual period of the patient
measure: vaginal bleeding rate
timeFrame: 6-7 weeks after the last menstrual period of the patient
measure: interference with intercourse rate
timeFrame: 6-7 weeks after the last menstrual period of the patient
measure: overall satisfaction score
timeFrame: 6-7 weeks after the last menstrual period of the patient
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Memorial Şişli Hospital
state: Şişli
Study officials:
affiliation: Memorial Şişli Hospital
name: Semra Kahraman, Prof
role: PRINCIPAL_INVESTIGATOR
References: