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

Primary Purpose

Infertility, Female, Infertility, Male, Embryo Transfer

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Dydrogesterone 10 MG Oral Tablet
Progesterone Vaginal Gel [Crinone]
Sponsored by
Memorial Sisli Hospital, Istanbul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring oral dydrogesterone, luteal phase support, vaginal progesterone gel, frozen-thawed embryo transfer

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Memorial Şişli HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dydrogesterone

Vaginal progesterone

Arm Description

Outcomes

Primary Outcome Measures

Ongoing pregnancy rate
Presence of at least one live fetus at the end of the 12th gestational week

Secondary Outcome Measures

Clinical pregnancy rate
Presence of an intrauterine gestational sac with fetal heart beat at 7th week of gestation
Implantation rate
Percentage of gestational sacs compared to the number of embryos transferred
Biochemical pregnancy
Positive serum beta HCG test performed 10 days after embryo transfer
Biochemical miscarriage
pregnancy loss before ultrasonographic detection of an intrauterine gestational sac
Clinical miscarriage
pregnancy loss after ultrasonographic detection of an intrauterine gestational sac
headache rate
interference with coitus rate
somnolence rate
dizziness rate
nausea/vomiting rate
vaginal discharge rate
perineal irritation rate
abdominal pain rate
mastalgia rate
vaginal bleeding rate
interference with intercourse rate
overall satisfaction score
patient satisfaction from the drug used measured on a 1-5 scale

Full Information

First Posted
October 10, 2019
Last Updated
October 10, 2019
Sponsor
Memorial Sisli Hospital, Istanbul
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1. Study Identification

Unique Protocol Identification Number
NCT04124913
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Memorial Sisli Hospital, Istanbul

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dydrogesterone
Arm Type
Experimental
Arm Title
Vaginal progesterone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dydrogesterone 10 MG Oral Tablet
Other Intervention Name(s)
Duphaston
Intervention Description
Oral dydrogesterone 10 mg tablet three times a day for luteal phase support
Intervention Type
Drug
Intervention Name(s)
Progesterone Vaginal Gel [Crinone]
Other Intervention Name(s)
Crinone %8 vaginal progesterone gel
Intervention Description
Vaginal progesterone gel 90 mg once a day for luteal phase support
Primary Outcome Measure Information:
Title
Ongoing pregnancy rate
Description
Presence of at least one live fetus at the end of the 12th gestational week
Time Frame
12 weeks after the last menstrual period of the patient
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Presence of an intrauterine gestational sac with fetal heart beat at 7th week of gestation
Time Frame
6-7 weeks after the last menstrual period of the patient
Title
Implantation rate
Description
Percentage of gestational sacs compared to the number of embryos transferred
Time Frame
5 weeks after the last menstrual period of the patient
Title
Biochemical pregnancy
Description
Positive serum beta HCG test performed 10 days after embryo transfer
Time Frame
10 days after embryo transfer
Title
Biochemical miscarriage
Description
pregnancy loss before ultrasonographic detection of an intrauterine gestational sac
Time Frame
before 5th gestational week
Title
Clinical miscarriage
Description
pregnancy loss after ultrasonographic detection of an intrauterine gestational sac
Time Frame
after 5th gestational week
Title
headache rate
Time Frame
6-7 weeks after the last menstrual period of the patient
Title
interference with coitus rate
Time Frame
6-7 weeks after the last menstrual period of the patient
Title
somnolence rate
Time Frame
6-7 weeks after the last menstrual period of the patient
Title
dizziness rate
Time Frame
6-7 weeks after the last menstrual period of the patient
Title
nausea/vomiting rate
Time Frame
6-7 weeks after the last menstrual period of the patient
Title
vaginal discharge rate
Time Frame
6-7 weeks after the last menstrual period of the patient
Title
perineal irritation rate
Time Frame
6-7 weeks after the last menstrual period of the patient
Title
abdominal pain rate
Time Frame
6-7 weeks after the last menstrual period of the patient
Title
mastalgia rate
Time Frame
6-7 weeks after the last menstrual period of the patient
Title
vaginal bleeding rate
Time Frame
6-7 weeks after the last menstrual period of the patient
Title
interference with intercourse rate
Time Frame
6-7 weeks after the last menstrual period of the patient
Title
overall satisfaction score
Description
patient satisfaction from the drug used measured on a 1-5 scale
Time Frame
6-7 weeks after the last menstrual period of the patient

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gonul Ozer, MD
Phone
+905326945549
Email
drgonulozer@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kadriye B Yuksel, MD
Phone
+905438852666
Email
berilyuksel@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Semra Kahraman, Prof
Organizational Affiliation
Memorial Şişli Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Şişli Hospital
City
Istanbul
State/Province
Şişli
ZIP/Postal Code
34385
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gonul Ozer, MD
Phone
+905326945549
Email
drgonulozer@gmail.com
First Name & Middle Initial & Last Name & Degree
Kadriye B Yuksel, Assoc. Prof.
Phone
+905438852666
Email
berilyuksel@gmail.com
First Name & Middle Initial & Last Name & Degree
Semra Kahraman, Prof.
First Name & Middle Initial & Last Name & Degree
Gonul Ozer, MD
First Name & Middle Initial & Last Name & Degree
Kadriye B Yüksel, Assoc. Prof.
First Name & Middle Initial & Last Name & Degree
Ozge S Yucel Cicek, Asst. Prof.

12. IPD Sharing Statement

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

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