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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Şişli
    • Istanbul, Şişli, Turkey, 34385
      • Recruiting
      • Memorial Sisli Hospital
      • Contact: Gonul Ozer, MD; Phone Number: +905326945549; Email: drgonulozer@gmail.com
      • Contact: Kadriye B Yuksel, Assoc. Prof.; Phone Number: +905438852666; Email: berilyuksel@gmail.com
      • Principal Investigator: Semra Kahraman, Prof.
      • Sub-Investigator: Gonul Ozer, MD
      • Sub-Investigator: Kadriye B Yüksel, Assoc. Prof.
      • Sub-Investigator: Ozge S Yucel Cicek, Asst. Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
Implantation rate	Percentage of gestational sacs compared to the number of embryos transferred	5 weeks after the last menstrual period of the patient
Clinical miscarriage	pregnancy loss after ultrasonographic detection of an intrauterine gestational sac	after 5th gestational week
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
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
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

Collaborators and Investigators

• Sponsor: Memorial Sisli Hospital, Istanbul
• Investigators: Principal Investigator: Semra Kahraman, Prof, Memorial Sisli Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Anticipated): October 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: October 10, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: luteal phase support; frozen-thawed embryo transfer; oral dydrogesterone; vaginal progesterone gel
• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Infertility, Male; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Progesterone; Dydrogesterone
• Other Study ID Numbers: 2019/001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No