HCG Versus Spontaneous LH in Intrauterine Insemination (IUI ) Cycles

This study has been completed.
Sponsor:
Information provided by:
Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier:
NCT01414673
First received: August 5, 2011
Last updated: August 10, 2011
Last verified: August 2011
  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
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 36 Years
Genders 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
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: NCT01414673

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

Publications:
Responsible Party: Devroey Paul, CRG
ClinicalTrials.gov Identifier: NCT01414673     History of Changes
Other Study ID Numbers: WAS11
Study First Received: August 5, 2011
Last Updated: August 10, 2011
Health Authority: Belgium:institunional review board

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

ClinicalTrials.gov processed this record on October 01, 2014