Luteal Support and Intrauterine Insemination (IUI) With C... | NCT01046708

Studies
Luteal Support and Intrauterine Insemination (IUI) With Clomiphene Citrate

NCT01046708

Sponsor

Universitair Ziekenhuis Brussel

Status

Completed

Last Update Posted

Jul 3, 2013Estimated

Enrollment

300Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

micronized progesterone

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Jul 2012Actual

First Submitted Date

Jan 11, 2010

First Submission Date that Met QC Criteria

Jan 11, 2010

First Posted Date

Jan 12, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2013

Last Update Posted Date

Jul 3, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the effect of luteal phase supplement (LPS) on pregnancy rate in IUI cycles stimulated with clomiphene citrate.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
micronized progesterone	Experimental		Drug: micronized progesterone
no utrogestan	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
micronized progesterone	Drug	600mg in 3 separate doses per day	micronized progesterone

Measure	Description	Time Frame
ongoing pregnancy rate		1 year

Measure	Description	Time Frame
implantation rate,clinical pregnancy rate		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≤ 36 years
Body mass index between 18 and 29
Presence of both ovaries
Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle and a day three FSH level of <12IU/L
Patients can enter the study only once.
Only the first IUI attempt will be included ( at the 2nd and 3 rd attempt progesterone could be administrated if it is necessary but these attempts will be excluded from the study)
Normal HSG (maximum 3 months prior starting the stimulation).
Donor sperm can be included

Exclusion Criteria:

Polycystic ovarian syndrome (Rotterdam criteria)
Endometriosis(≥AFS III)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

36 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20719809	Derived	Kyrou D, Fatemi HM, Tournaye H, Devroey P. Luteal phase support in normo-ovulatory women stimulated with clomiphene citrate for intrauterine insemination: need or habit? Hum Reprod. 2010 Oct;25(10):2501-6. doi: 10.1093/humrep/deq223. Epub 2010 Aug 18.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D011374	Progesterone
C000624167	Utrogestan

ID	Term
D011282	Pregnenediones
D011283	Pregnenes
D011278	Pregnanes
D013256	Steroids
D000072473