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

This study has been completed.

Sponsor:

Information provided by:

Baskent University

ClinicalTrials.gov Identifier:

NCT00993902

First received: July 22, 2009

Last updated: October 13, 2009

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

July 22, 2009

Last Updated Date

October 13, 2009

Start Date ^ICMJE

May 2008

Primary Completion Date

May 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

ongoing pregnancy rates [ Time Frame: pregnancy >12 weeks of gestation ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

The effects of different coh regimens on outcomes [ Time Frame: 14 days after IUI procedure ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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:

Patients with unexplained infertility or mild male factor infertility whom admitted to the COH+IUI programme in our infertility unit.
Female age <37 years old.
Baseline FSH <12 mIU/L
Total antral follicle count>6
During the first three cycles of COH+IUI
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 Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Infertility

Intervention ^ICMJE

Procedure: Intrauterine insemination (single)
Single IUI after 36-38 hours of HCG

Other Name: Group I
Procedure: Double intrauterine insemination
Double insemination after 18 and 40 hours of HCG administration.

Other Name: Grup II

Study Arms

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

Intervention: Procedure: Intrauterine insemination (single)
Active Comparator: Double IUI
Intervention: Procedure: Double intrauterine insemination

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

228

Completion Date

July 2009

Primary Completion Date

May 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Female

Ages

20 Years to 37 Years (Adult)

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Turkey

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00993902

Other Study ID Numbers ^ICMJE

BU1

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Associated Prof.Tayfun Bagis, MD

Study Sponsor ^ICMJE

Baskent University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

PRS Account

Baskent University

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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