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Intrauterine Insemination and Luteal Fase Support

Primary Purpose

Infertility

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
crinone (progesterone 8%, vaginal application)
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring intrauterine insemination, luteal phase, gonadotrophins

Eligibility Criteria

18 Years - 43 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UZ Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental

control

Arm Description

Luteal Phase support

No luteal Phase support

Outcomes

Primary Outcome Measures

clinical pregnancy rate per IUI cycle

Secondary Outcome Measures

live birth rate per IUI cycle

Full Information

First Posted
February 25, 2013
Last Updated
October 17, 2018
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01826747
Brief Title
Intrauterine Insemination and Luteal Fase Support
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 2011 (Actual)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
intrauterine insemination, luteal phase, gonadotrophins

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
393 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
Luteal Phase support
Arm Title
control
Arm Type
No Intervention
Arm Description
No luteal Phase support
Intervention Type
Drug
Intervention Name(s)
crinone (progesterone 8%, vaginal application)
Primary Outcome Measure Information:
Title
clinical pregnancy rate per IUI cycle
Time Frame
by ultrasound at ± 5 to 6 weeks after IUI
Secondary Outcome Measure Information:
Title
live birth rate per IUI cycle
Time Frame
40 weeks after IUI

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
43 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
27565253
Citation
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.
Results Reference
derived

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Intrauterine Insemination and Luteal Fase Support

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