Intrauterine Insemination and Luteal Fase Support

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01826747
First received: February 25, 2013
Last updated: June 25, 2014
Last verified: November 2012
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • live birth rate per IUI cycle [ Time Frame: 40 weeks after IUI ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   18 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826747

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

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01826747     History of Changes
Other Study ID Numbers: S52775
Study First Received: February 25, 2013
Last Updated: June 25, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

Keywords provided by Universitaire Ziekenhuizen Leuven:
intrauterine insemination
luteal phase
gonadotrophins

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014