Intrauterine Insemination and Luteal Fase Support

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01826747
Recruitment Status : Unknown
Verified November 2012 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Enrolling by invitation
First Posted : April 8, 2013
Last Update Posted : June 26, 2014
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: crinone (progesterone 8%, vaginal application) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2011
Estimated Primary Completion Date : May 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: experimental Drug: crinone (progesterone 8%, vaginal application)

Primary Outcome Measures :
  1. clinical pregnancy rate per IUI cycle [ Time Frame: by ultrasound at ± 5 to 6 weeks after IUI ]

Secondary Outcome Measures :
  1. live birth rate per IUI cycle [ Time Frame: 40 weeks after IUI ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients with an indication for IUI:

  • unexplained infertility
  • mild male factor infertility
  • minimal-mild endometriosis


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01826747

UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT01826747     History of Changes
Other Study ID Numbers: S52775
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: November 2012

Keywords provided by Universitaire Ziekenhuizen Leuven:
intrauterine insemination
luteal phase

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs