Luteal Support and Intrauterine Insemination (IUI) With Clomiphene Citrate

NCT ID: NCT01046708

Last Updated: 2013-07-03

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

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2012-07-31

Brief Summary

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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

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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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micronized progesterone

Group Type EXPERIMENTAL

micronized progesterone

Intervention Type DRUG

600mg in 3 separate doses per day

no utrogestan

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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micronized progesterone

600mg in 3 separate doses per day

Intervention Type DRUG

Other Intervention Names

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utrogestan

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Kyrou Dimitra

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 20719809 (View on PubMed)

Other Identifiers

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CFER

Identifier Type: -

Identifier Source: org_study_id

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