HCG Versus Spontaneous LH in Intrauterine Insemination (IUI ) Cycles
Spontaneous Triggering of Ovulation vs. Administration of Human Chorionic Gonadotropin in Patients Undergoing Intrauterine Insemination: a Prospective Randomized Study.
1 other identifier
interventional
300
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Apr 2009
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
August 5, 2011
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedAugust 11, 2011
August 1, 2011
2.2 years
August 5, 2011
August 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ongoing pregnancy rate
1 year
Study Arms (2)
spontaneous LH
OTHERHCG
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- PCOS
- endometriosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uzbrussel
Brussels, Laarbeeklaan 101, 1090, Belgium
Related Publications (2)
Kosmas IP, Tatsioni A, Fatemi HM, Kolibianakis EM, Tournaye H, Devroey P. Human chorionic gonadotropin administration vs. luteinizing monitoring for intrauterine insemination timing, after administration of clomiphene citrate: a meta-analysis. Fertil Steril. 2007 Mar;87(3):607-12. doi: 10.1016/j.fertnstert.2006.10.003. Epub 2006 Dec 14.
PMID: 17173907RESULTKyrou D, Kolibianakis EM, Fatemi HM, Grimbizis GF, Theodoridis TD, Camus M, Tournaye H, Tarlatzis BC, Devroey P. Spontaneous triggering of ovulation versus HCG administration in patients undergoing IUI: a prospective randomized study. Reprod Biomed Online. 2012 Sep;25(3):278-83. doi: 10.1016/j.rbmo.2012.05.005. Epub 2012 May 23.
PMID: 22796236DERIVED
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 5, 2011
First Posted
August 11, 2011
Study Start
April 1, 2009
Primary Completion
July 1, 2011
Study Completion
August 1, 2011
Last Updated
August 11, 2011
Record last verified: 2011-08