Impact of Clomiphene Citrate Administration During the Early Luteal Phase on Endocrine Profile in IVF Cycles (CLOFA)

February 12, 2013 updated by: Fundació Privada Eugin

Impact of Clomiphene Citrate Administration During the Early Luteal Phase on Endocrine Profile in Agonist Triggered GnRH Antagonist in Vitro Fertilization Cycles. Phase IV, Single-centre, Open-label, Controlled Clinical Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08029
        • Clinica EUGIN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Oocyte donors
  • 18-35 years old
  • BMI 18-29 Kg/m2
  • Normal basal hormonal levels
  • No contraceptive pill

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Experimental: Clomifene Citrate
Clomifene Citrate 50 mg
Drug: Clomifene Citrate
Clomiphene citrate 100 mg daily for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
LH Levels (IU)
Time Frame: Luteal phase (up to 2 weeks)
Luteal phase (up to 2 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Endometrial development (Noyes criteria)
Time Frame: Luteal phase (1 day)
Luteal phase (1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Privada Eugin

Investigators

  • Principal Investigator: Marta Colodron, MD, Clinica EUGIN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

November 12, 2012

First Submitted That Met QC Criteria

February 12, 2013

First Posted (Estimate)

February 15, 2013

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 12, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLOFA
  • 2011-002173-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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