HCG Versus Spontaneous LH in Intrauterine Insemination (IUI ) Cycles

Spontaneous Triggering of Ovulation vs. Administration of Human Chorionic Gonadotropin in Patients Undergoing IUI Clinical Trial

Official title:

Spontaneous Triggering of Ovulation vs. Administration of Human Chorionic Gonadotropin in Patients Undergoing Intrauterine Insemination: a Prospective Randomized Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414673
• Other study ID #: WAS11
• Status: Completed
• Phase: Phase 0
• First received: August 5, 2011
• Last updated: August 10, 2011
• Start date: April 2009
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium:institunional review board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spontaneous Triggering of Ovulation vs. Administration of Human Chorionic Gonadotropin in Patients Undergoing IUI

Intervention

Drug:
• HCG
5000 IU

Locations

Country	Name	City	State
Belgium	Uzbrussel	Brussel	Laarbeeklaan 101

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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 Ster — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ongoing pregnancy rate		1 year	Yes