Dydrogesterone Versus Intravaginal Progesterone in the Luteal Phase Support
Oral Dydrogesterone Versus Vaginal Progesterone Gel in the Luteal Phase Support: Randomized Controlled Trial
1 other identifier
interventional
853
1 country
1
Brief Summary
The purpose of this study is to compare efficacy and tolerability of the dydrogesterone and the vaginal progesterone, used for luteal phase support. (Initial start date was January 2009 but not for patients' recruitment only for paper work, documents, team organization, statistical pre-work actions and to gain the official approval of Institutional Review Board. The recruitment started in October 2010 and continued until October 2013.)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2010
CompletedFirst Posted
Study publicly available on registry
August 10, 2010
CompletedStudy Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 29, 2014
January 1, 2014
3 years
August 9, 2010
January 27, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ongoing pregnancy rate
Ongoing pregnancy rate is defined by the presence of gestational sac(s) with viable fetal heart beats at 12 weeks' gestation by transvaginal ultrasound.
12 weeks
Secondary Outcomes (2)
Number of participants with adverse events
10 weeks
Satisfaction
10 weeks
Study Arms (2)
Oral dydrogesterone
ACTIVE COMPARATORStudy group receiving 2x10mg of oral dydrogesterone until a pregnancy test or in the case of pregnancy until 10 week.
Crinone 8% vaginal gel
ACTIVE COMPARATORControl group is receiving vaginal gel, 1x90mg, until a pregnancy test or in the case of pregnancy until 10 week.
Interventions
oral-2x10mg
vaginal-1x90mg
Eligibility Criteria
You may qualify if:
- routine ovulation induction protocol with GnRH agonist
- less than three prior IVF cycles
- at least three aspirated oocytes
- BMI \<35 kg/m2
- age \<45 years
You may not qualify if:
- history of dysfunctional uterine bleeding
- acute urogenital disease
- recurrent miscarriage
- previous allergic reactions to a progesterone products
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Center Sisters of Mercy
Zagreb, 10000, Croatia
Related Publications (1)
Tomic V, Tomic J, Klaic DZ, Kasum M, Kuna K. Oral dydrogesterone versus vaginal progesterone gel in the luteal phase support: randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Mar;186:49-53. doi: 10.1016/j.ejogrb.2014.11.002. Epub 2014 Nov 20.
PMID: 25622239DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jozo Tomic, M.D.
Department of Human Reproduction, University Hospital Center Sisters of Mercy
- STUDY CHAIR
Vlatka Tomic, M.D.
Department of Human Reproduction, University Hospital Center Sisters of Mercy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
August 9, 2010
First Posted
August 10, 2010
Study Start
October 1, 2010
Primary Completion
October 1, 2013
Study Completion
December 1, 2013
Last Updated
January 29, 2014
Record last verified: 2014-01