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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04124913
• Other study ID #: 2019/001
• Status: Recruiting
• Phase: Phase 4
• Start date: January 2, 2019
• Est. completion date: December 2019

Study information

• Verified date: October 2019
• Source: Memorial Sisli Hospital, Istanbul
• Contact: Gonul Ozer, MD
• Phone: +905326945549
• Email: drgonulozer[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Dydrogesterone 10 MG Oral Tablet
Oral dydrogesterone 10 mg tablet three times a day for luteal phase support
• Progesterone Vaginal Gel [Crinone]
Vaginal progesterone gel 90 mg once a day for luteal phase support

Locations

Country	Name	City	State
Turkey	Memorial Sisli Hospital	Istanbul	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sisli Hospital, Istanbul

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Implantation rate	Percentage of gestational sacs compared to the number of embryos transferred	5 weeks after the last menstrual period of the patient
Secondary	Biochemical pregnancy	Positive serum beta HCG test performed 10 days after embryo transfer	10 days after embryo transfer
Secondary	Biochemical miscarriage	pregnancy loss before ultrasonographic detection of an intrauterine gestational sac	before 5th gestational week
Secondary	Clinical miscarriage	pregnancy loss after ultrasonographic detection of an intrauterine gestational sac	after 5th gestational week
Secondary	headache rate		6-7 weeks after the last menstrual period of the patient
Secondary	interference with coitus rate		6-7 weeks after the last menstrual period of the patient
Secondary	somnolence rate		6-7 weeks after the last menstrual period of the patient
Secondary	dizziness rate		6-7 weeks after the last menstrual period of the patient
Secondary	nausea/vomiting rate		6-7 weeks after the last menstrual period of the patient
Secondary	vaginal discharge rate		6-7 weeks after the last menstrual period of the patient
Secondary	perineal irritation rate		6-7 weeks after the last menstrual period of the patient
Secondary	abdominal pain rate		6-7 weeks after the last menstrual period of the patient
Secondary	mastalgia rate		6-7 weeks after the last menstrual period of the patient
Secondary	vaginal bleeding rate		6-7 weeks after the last menstrual period of the patient
Secondary	interference with intercourse rate		6-7 weeks after the last menstrual period of the patient
Secondary	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