Intrauterine Insemination and Luteal Fase Support
NCT01826747 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 393
Last updated 2018-10-19
Summary
The objective is to test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary outcome) when compared to no luteal phase support in a program of intrauterine insemination (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of the luteal phase will be recorded (secondary outcome) in order to detect luteal phase defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase prolongation in case of luteal phase support which may be a burden for the patients waiting for the outcome of the treatment.
Conditions
Interventions
- DRUG
-
crinone (progesterone 8%, vaginal application)
Sponsors & Collaborators
-
Universitaire Ziekenhuizen KU Leuven
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 43 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-04-30
- Primary Completion
- 2015-01-31
- Completion
- 2016-06-30
Countries
- Belgium
Study Locations
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