Clomifene Citrate as First Line Treatment in in Vitro Fertilization Cycles for Patients With Lower Ovarian Reserve (clomid)

July 11, 2011 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Patients With Reduced Ovarian Reserve and In Vitro Fertilization (IVF) Cycles. A Randomized Multicentric Comparison of a Protocol With High Doses of Gonadotropins and a Protocol With Clomiphene Citrate Only. Evaluation of Clinical Effectiveness and Economic Issues

Women with compromised ovarian reserve requiring in vitro fertilization (IVF) still represent a demanding challenge for clinicians. It has classically been claimed that using higher dosages of gonadotropins may overcome the scarce ovarian responsiveness to hyper-simulation and increase the chances of success. However, scientific evidence supporting this view is scanty and costs are inevitably much higher. In this study, the investigators hypothesized that similar chances of pregnancy may be achieved with a mild stimulation using exclusively Clomiphene citrate (CC).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

289

Phase

  • Not Applicable

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

  • Italy
      • Milan, Italy, 20122
        • Fondazione Ca' Granda Ospedale Maggiore Policlinico

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 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • age 18-42 years
  • infertility status
  • Day 3 serum FSH > 12 IU/ml in at least two occasions or previous poor response (≤3 oocytes retrieved) to hyper-stimulation

Exclusion Criteria:

  • contraindications to infertility treatments or pregnancy

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High doses
Administration of high doses of gonadotrophins to stimulate ovarian follicular growth
Drug: GnRH analog and recombinant human FSH
daily subcutaneous 0.1 mg decapeptyl from day 1-2 of the menstrual cycle and recombinant human FSH 450 IU/die from day 3.
Other Names:
  • decapeptyl
  • Gonal-F
Experimental: Clomid
Administration of Clomiphene Citrate to obtain ovarian follicular growth
Drug: Clomifene Citrate
3x50 mg die for 5 days from day 3 to day 7 of the menstrual cycle
Other Names:
  • clomid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live birth rate
Time Frame: end of the study (28 months)

general "Live birth rate" will be recorded at the end of the study when all participants have performed their In vitro Fertilization (IVF) treatment.

Live birth rate per single patients will be recorded 4 weeks after embryo transfer when a intrauterine gestational sac is expected to be seen in case of pregnancy.
end of the study (28 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ratio pregnancies/costs
Time Frame: end of the study (28 months)
at the end of the study the number of obtained pregnancies will be divided by the total costs of treatments in two groups. A cost in euros will be therefore estimated for every single pregnancy in both groups.
end of the study (28 months)

Collaborators and Investigators

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

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborators

IRCCS San Raffaele
Istituto Clinico Humanitas
Istituti Clinici Zucchi

Investigators

  • Principal Investigator: guido ragni, md, Fondazione Ca' Granda Ospedale Maggiore Policlinico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2008

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

July 1, 2011

First Submitted That Met QC Criteria

July 7, 2011

First Posted (Estimate)

July 8, 2011

Study Record Updates

Last Update Posted (Estimate)

July 12, 2011

Last Update Submitted That Met QC Criteria

July 11, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • clomid re-007

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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