Double and Single Intrauterine Insemination In Controlled Ovarian Stimulation (COH) Cycles With Multifollicular Development

Infertility Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993902
• Other study ID #: BU1
• Status: Completed
• Phase: Phase 4
• First received: July 22, 2009
• Last updated: October 13, 2009
• Start date: May 2008
• Est. completion date: July 2009

Study information

• Verified date: October 2009
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Our hypothesis is double insemination will improve pregnancy rates in coh cycles with more than one dominant follicles (>16mm).

Description:

Metaanalysis for the effects of double IUI demonstrates that effects of this procedure is not different from single IUI. It is known that nearly 25% of coh cycles is evident by monofollicular development.For this reason it is possible that this monofollicular cycles in the studies could decrease the effects of double IUI.

Inclusion criteria:

1. Patients with unexplained infertility or mild male factor infertility whom admitted to the COH+IUI programme in our infertility unit.

2. Female age <37 years old.

3. Baseline FSH <12 mIU/L

4. Total antral follicle count>6

5. During the first three cycles of COH+IUI

6. Minimum 2 follicles >16 mm at the day of HCG.

Primary outcome:

Ongoing pregnancy rates

Secondary outcomes:

The effects of different coh regimens (CC,FSH,CC+FSH)on the outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: July 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 37 Years

Eligibility

Inclusion Criteria:

• Unexplained and mild male factor infertile patients

• Minimum 2 follicles >16 mm at the day of HCG

• First 3 cycles

Exclusion Criteria:

• Basal FSH >12 mIU/L

• Total antral follicle count<6

• Severe male factor infertility

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Intrauterine insemination (single)
Single IUI after 36-38 hours of HCG
• Double intrauterine insemination
Double insemination after 18 and 40 hours of HCG administration.

Locations

Country	Name	City	State
Turkey	Baskent University Medical Faculty Obstetric and Gynecelogy Department, Infertility and IVF unit	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ongoing pregnancy rates		pregnancy >12 weeks of gestation	Yes
Secondary	The effects of different coh regimens on outcomes		14 days after IUI procedure	Yes