NCT01791751

Brief Summary

The purpose of this study is to evaluate the effect on LH levels of the 5-day CC administration during luteal phase in oocyte donors, to investigate whether the CC corrects the suppressed LH levels in the luteal phase and whether it prolongs the luteal phase in the agonist triggered antagonist cycles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

8 months

First QC Date

November 12, 2012

Last Update Submit

February 12, 2013

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (1)

  • LH Levels (IU)

    Luteal phase (up to 2 weeks)

Secondary Outcomes (1)

  • Endometrial development (Noyes criteria)

    Luteal phase (1 day)

Study Arms (2)

Clomifene Citrate

EXPERIMENTAL

Clomifene Citrate 50 mg

Drug: Clomifene Citrate

Control

NO INTERVENTION

No intervention

Interventions

Clomifene CitrateDRUG

Clomiphene citrate 100 mg daily for 5 days

Clomifene Citrate

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Oocyte donors
  • years old
  • BMI 18-29 Kg/m2
  • Normal basal hormonal levels
  • No contraceptive pill

You may not qualify if:

  • Polycystic ovarian syndrome (PCOS)
  • Previous participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica EUGIN

Barcelona, Barcelona, 08029, Spain

Location

MeSH Terms

Conditions

Infertility, Female

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Marta Colodron, MD

    Clinica EUGIN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2012

First Posted

February 15, 2013

Study Start

June 1, 2012

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

ES(1)