Intrauterine Insemination and Luteal Fase Support
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.
1 other identifier
interventional
393
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2011
Longer than P75 for phase_4
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
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 25, 2013
CompletedFirst Posted
Study publicly available on registry
April 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedOctober 19, 2018
October 1, 2018
3.8 years
February 25, 2013
October 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinical pregnancy rate per IUI cycle
by ultrasound at ± 5 to 6 weeks after IUI
Secondary Outcomes (1)
live birth rate per IUI cycle
40 weeks after IUI
Study Arms (2)
experimental
EXPERIMENTALLuteal Phase support
control
NO INTERVENTIONNo luteal Phase support
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with contra-indication for pregnancy , infertility or progesterone use.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Leuven
Leuven, 3000, Belgium
Related Publications (1)
Peeraer K, D'Hooghe T, Laurent P, Pelckmans S, Delvigne A, Laenen A, Welkenhuysen M, Wyns C, De Neubourg D. Impact of luteal phase support with vaginal progesterone on the clinical pregnancy rate in intrauterine insemination cycles stimulated with gonadotropins: a randomized multicenter study. Fertil Steril. 2016 Nov;106(6):1490-1495. doi: 10.1016/j.fertnstert.2016.07.1096. Epub 2016 Aug 23.
PMID: 27565253DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2013
First Posted
April 8, 2013
Study Start
April 1, 2011
Primary Completion
January 1, 2015
Study Completion
June 1, 2016
Last Updated
October 19, 2018
Record last verified: 2018-10