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Luteal Support and Intrauterine Insemination (IUI) With Clomiphene Citrate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyrou Dimitra, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT01046708
First received: January 11, 2010
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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 Intervention
Infertility
Drug: micronized progesterone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ovulation Induction With Clomiphene Citrate: to Support or Not to Support the Luteal Phase

Resource links provided by NLM:


Further study details as provided by Universitair Ziekenhuis Brussel:

Primary Outcome Measures:
  • ongoing pregnancy rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • implantation rate,clinical pregnancy rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 300
Study Start Date: September 2008
Study Completion Date: July 2012
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: micronized progesterone Drug: micronized progesterone
600mg in 3 separate doses per day
Other Name: utrogestan
No Intervention: no utrogestan

  Eligibility

Ages Eligible for Study:   18 Years to 36 Years
Genders 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)
  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.

No Contacts or Locations Provided
  More Information

No publications provided by Universitair Ziekenhuis Brussel

Additional 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
Study First Received: January 11, 2010
Last Updated: July 1, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by Universitair Ziekenhuis Brussel:
IUI
clomiphene citrate
utrogestan

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Genital Diseases, Male
Clomiphene
Enclomiphene
Progesterone
Zuclomiphene
Estrogen Antagonists
Estrogen Receptor Modulators
Fertility Agents
Fertility Agents, Female
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014