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

Phase 4

Completed

• Conditions: Infertility
• Interventions: Procedure: Intrauterine insemination (single); Procedure: Double intrauterine insemination

• Registration Number: NCT00993902
• Lead Sponsor: Baskent University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2009-05
• Study Completion: 2009-07
• Study First Submitted: 2009-07-22
• Status Verified: 2009-10
• Study First Submitted QC: 2009-10-13
• Last Update Submitted: 2009-10-13
• Study First Posted: 2009-10-14
• Last Update Posted: 2009-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 228

Inclusion Criteria

• Unexplained and mild male factor infertile patients
• Minimum 2 follicles >16 mm at the day of HCG
• First 3 cycles

Read More

Exclusion Criteria

• Basal FSH >12 mIU/L
• Total antral follicle count<6
• Severe male factor infertility

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single IUI	Intrauterine insemination (single)	Single IUI will be carried on after 36-38 hours of HCG administration
Double IUI	Double intrauterine insemination	-

Primary Outcome Measures

Name	Time	Method
ongoing pregnancy rates	pregnancy >12 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
The effects of different coh regimens on outcomes	14 days after IUI procedure

Trial Locations

Locations (1)

Baskent University Medical Faculty Obstetric and Gynecelogy Department, Infertility and IVF unit; 🇹🇷 Adana, Turkey