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

Baskent University

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Procedure: Intrauterine insemination (single); Procedure: Double intrauterine insemination

Study type: Interventional

Funder types: Other

Identifiers

NCT00993902

BU1

Details and patient eligibility

About

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

Full 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.

Enrollment: 228 patients

Sex: Female

Ages: 20 to 37 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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228 participants in 2 patient groups

Single IUI

Sham Comparator group

Description:

Single IUI will be carried on after 36-38 hours of HCG administration

Treatment:

Procedure: Intrauterine insemination (single)

Double IUI

Active Comparator group

Treatment:

Procedure: Double intrauterine insemination