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Intrauterine Insemination and Luteal Fase Support

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Enrolling by invitation
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven Identifier:
First received: February 25, 2013
Last updated: June 25, 2014
Last verified: November 2012
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 Intervention Phase
Infertility Drug: crinone (progesterone 8%, vaginal application) Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Universitaire Ziekenhuizen Leuven:

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

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

Enrollment: 198
Study Start Date: April 2011
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: experimental Drug: crinone (progesterone 8%, vaginal application)


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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01826747

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

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
Study First Received: February 25, 2013
Last Updated: June 25, 2014

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 processed this record on September 21, 2017