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

NCT ID: NCT00993902

Last Updated: 2009-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single IUI

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

Group Type SHAM_COMPARATOR

Intrauterine insemination (single)

Intervention Type PROCEDURE

Single IUI after 36-38 hours of HCG

Double IUI

Group Type ACTIVE_COMPARATOR

Double intrauterine insemination

Intervention Type PROCEDURE

Double insemination after 18 and 40 hours of HCG administration.

Interventions

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Intrauterine insemination (single)

Single IUI after 36-38 hours of HCG

Intervention Type PROCEDURE

Double intrauterine insemination

Double insemination after 18 and 40 hours of HCG administration.

Intervention Type PROCEDURE

Other Intervention Names

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Group I Grup II

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Baskent University

OTHER

Sponsor Role lead

Responsible Party

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Associated Prof.Tayfun Bagis, MD

Locations

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Baskent University Medical Faculty Obstetric and Gynecelogy Department, Infertility and IVF unit

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Bagis T, Haydardedeoglu B, Kilicdag EB, Cok T, Simsek E, Parlakgumus AH. Single versus double intrauterine insemination in multi-follicular ovarian hyperstimulation cycles: a randomized trial. Hum Reprod. 2010 Jul;25(7):1684-90. doi: 10.1093/humrep/deq112. Epub 2010 May 10.

Reference Type DERIVED
PMID: 20457669 (View on PubMed)

Other Identifiers

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BU1

Identifier Type: -

Identifier Source: org_study_id

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