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Luteal Support and Intrauterine Insemination (IUI) With Clomiphene Citrate

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ClinicalTrials.gov Identifier: NCT01046708
Recruitment Status : Completed
First Posted : January 12, 2010
Last Update Posted : July 3, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess the effect of luteal phase supplement (LPS) on pregnancy rate in IUI cycles stimulated with clomiphene citrate.

Condition or disease Intervention/treatment
Infertility Drug: micronized progesterone

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ovulation Induction With Clomiphene Citrate: to Support or Not to Support the Luteal Phase
Study Start Date : September 2008
Primary Completion Date : August 2009
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: micronized progesterone Drug: micronized progesterone
600mg in 3 separate doses per day
Other Name: utrogestan
No Intervention: no utrogestan


Outcome Measures

Primary Outcome Measures :
  1. ongoing pregnancy rate [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. implantation rate,clinical pregnancy rate [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≤ 36 years
  • Body mass index between 18 and 29
  • Presence of both ovaries
  • Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle and a day three FSH level of <12IU/L
  • Patients can enter the study only once.
  • Only the first IUI attempt will be included ( at the 2nd and 3 rd attempt progesterone could be administrated if it is necessary but these attempts will be excluded from the study)
  • Normal HSG (maximum 3 months prior starting the stimulation).
  • Donor sperm can be included

Exclusion Criteria:

  • Polycystic ovarian syndrome (Rotterdam criteria)
  • Endometriosis(≥AFS III)
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyrou Dimitra, Doctor, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT01046708     History of Changes
Other Study ID Numbers: CFER
First Posted: January 12, 2010    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: July 2013

Keywords provided by Kyrou Dimitra, Universitair Ziekenhuis Brussel:
IUI
clomiphene citrate
utrogestan

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Citric Acid
Progesterone
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators