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

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ClinicalTrials.gov Identifier: NCT01389713
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : July 12, 2011
Information provided by:

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment
Infertility Drug: Clomifene Citrate Drug: GnRH analog and recombinant human FSH

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 289 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2008
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: clomid

Outcome Measures

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01389713

Fondazione Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Istituto Clinico Humanitas
IRCCS San Raffaele
Istituti Clinici Zucchi
Principal Investigator: guido ragni, md Fondazione Ca' Granda Ospedale Maggiore Policlinico
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guido Ragni, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT01389713     History of Changes
Other Study ID Numbers: clomid re-007
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: July 12, 2011
Last Verified: July 2011

Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
ovarian reserve
ovarian stimulation
clomifene citrate
high doses Follicle Stimulating Hormone (FSH)

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Citric Acid
Triptorelin Pamoate
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents