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HCG Versus Spontaneous LH in Intrauterine Insemination (IUI ) Cycles

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01414673
First Posted: August 11, 2011
Last Update Posted: August 11, 2011
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.
Information provided by:
Universitair Ziekenhuis Brussel
  Purpose
We recently reported the superiority of the natural cycle to a natural cycle controlled by the administration of human chorionic gonadotropin (hCG) for planning the frozen-thawed embryo transfer cycles, demonstrating a probable negative impact of exogenous hCG on endometrial receptivity.Based on the above findings we conducted the first prospective study that assesses whether there is a difference in pregnancy rate after intrauterine insemination (IUI) in a natural cycle with spontaneous luteinizing hormone (LH) rise compared to natural cycles controlled by hCG for final ovulation.

Condition Intervention Phase
Spontaneous Triggering of Ovulation vs. Administration of Human Chorionic Gonadotropin in Patients Undergoing IUI Drug: HCG Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Spontaneous Triggering of Ovulation vs. Administration of Human Chorionic Gonadotropin in Patients Undergoing Intrauterine Insemination: a Prospective Randomized Study.

Further study details as provided by Universitair Ziekenhuis Brussel:

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

Enrollment: 300
Study Start Date: April 2009
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
spontaneous LH Drug: HCG
5000 IU
Experimental: HCG Drug: HCG
5000 IU

  Eligibility

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,
  • regular menstrual cycles,
  • body mass index (BMI) between 18 and 29 kg/m²,
  • basal levels of FSH (≤ 12 IU/l),
  • estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle, normal hysterosalpingography (maximum 3 months prior starting the cycle).
  • The use of donor sperm was also accepted as inclusion criteria.

Exclusion Criteria:

  • PCOS
  • endometriosis
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01414673


Locations
Belgium
Uzbrussel
Brussel, Laarbeeklaan 101, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Devroey Paul, CRG
ClinicalTrials.gov Identifier: NCT01414673     History of Changes
Other Study ID Numbers: WAS11
First Submitted: August 5, 2011
First Posted: August 11, 2011
Last Update Posted: August 11, 2011
Last Verified: August 2011

Keywords provided by Universitair Ziekenhuis Brussel:
IUI
HCG
Spontaneous LH
pregnancy

Additional relevant MeSH terms:
Chorionic Gonadotropin
Reproductive Control Agents
Physiological Effects of Drugs