NCT01046708

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 3, 2013

Status Verified

July 1, 2013

Enrollment Period

11 months

First QC Date

January 11, 2010

Last Update Submit

July 1, 2013

Conditions

Infertility

Keywords

IUIclomiphene citrateutrogestan

Outcome Measures

Primary Outcomes (1)

  • ongoing pregnancy rate

    1 year

Secondary Outcomes (1)

  • implantation rate,clinical pregnancy rate

    1 year

Study Arms (2)

micronized progesterone

EXPERIMENTAL
Drug: micronized progesterone

no utrogestan

NO INTERVENTION

Interventions

micronized progesteroneDRUG

600mg in 3 separate doses per day

Also known as: utrogestan
micronized progesterone

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 20719809DERIVED

MeSH Terms

Conditions

Infertility

Interventions

ProgesteroneUtrogestan

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 12, 2010

Study Start

September 1, 2008

Primary Completion

August 1, 2009

Study Completion

July 1, 2012

Last Updated

July 3, 2013

Record last verified: 2013-07