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

Phase 4

• Conditions: Infertility, Female; Infertility, Male; Embryo Transfer; Fertilization in Vitro; Drug Effect; Reproductive Techniques, Assisted; Progesterone; Dydrogesterone
• Interventions: Drug: Dydrogesterone 10 MG Oral Tablet; Drug: Progesterone Vaginal Gel [Crinone]

• Registration Number: NCT04124913
• Lead Sponsor: Memorial Sisli Hospital, Istanbul

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-02
• Status Verified: 2019-10
• Primary Completion: 2019-10
• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-10
• Last Update Submitted: 2019-10-10
• Study First Posted: 2019-10-14
• Last Update Posted: 2019-10-14
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dydrogesterone	Dydrogesterone 10 MG Oral Tablet	-
Vaginal progesterone	Progesterone Vaginal Gel [Crinone]	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
Implantation rate	5 weeks after the last menstrual period of the patient	Percentage of gestational sacs compared to the number of embryos transferred
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	6-7 weeks after the last menstrual period of the patient	patient satisfaction from the drug used measured on a 1-5 scale

Trial Locations

Locations (1)

Memorial Şişli Hospital; 🇹🇷 Istanbul, Şişli, Turkey