- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01826747
Intrauterine Insemination and Luteal Fase Support
October 17, 2018 updated by: Universitaire Ziekenhuizen KU Leuven
Impact of Luteal Phase Support With Vaginal Progesterone on the Clinical Pregnancy Rate in Intrauterine Insemination Cycles Stimulated With Gonadotrophins: a Prospective Randomized Multicentre Study.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
393
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leuven, Belgium, 3000
- UZ Leuven
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 43 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Patients with an indication for IUI:
- unexplained infertility
- mild male factor infertility
- minimal-mild endometriosis
Women:
- first IUI cycle ever
- normal ovulatory cycles (26-32d)
- age<43,BMI≤30
- presence of at least one patent tube on hysterosalpingography and/or laparoscopy
- normal uterine cavity (ultrasound, hysterosalpingography, or laparoscopy)
Men: Total motile count ≥ 5 Million/ml after capacitation
Exclusion Criteria:
- Patients with contra-indication for pregnancy , infertility or progesterone use.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: experimental
Luteal Phase support
|
|
No Intervention: control
No luteal Phase support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
clinical pregnancy rate per IUI cycle
Time Frame: by ultrasound at ± 5 to 6 weeks after IUI
|
by ultrasound at ± 5 to 6 weeks after IUI
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
live birth rate per IUI cycle
Time Frame: 40 weeks after IUI
|
40 weeks after IUI
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2011
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
February 25, 2013
First Submitted That Met QC Criteria
April 5, 2013
First Posted (Estimate)
April 8, 2013
Study Record Updates
Last Update Posted (Actual)
October 19, 2018
Last Update Submitted That Met QC Criteria
October 17, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S52775
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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