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

This study has been completed.
Sponsor:
Collaborators:
Istituto Clinico Humanitas
IRCCS San Raffaele
Istituti Clinici ZUcchi, Monza
Information provided by:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier:
NCT01389713
First received: July 1, 2011
Last updated: July 11, 2011
Last verified: July 2011
  Purpose

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 Intervention
Infertility
Drug: Clomifene Citrate
Drug: GnRH analog and recombinant human FSH

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:

Primary Outcome Measures:
  • live birth rate [ Time Frame: end of the study (28 months) ] [ Designated as safety issue: No ]

    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:
  • ratio pregnancies/costs [ Time Frame: end of the study (28 months) ] [ Designated as safety issue: No ]
    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.


Enrollment: 289
Study Start Date: September 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01389713

Locations
Italy
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, Monza
Investigators
Principal Investigator: guido ragni, md Fondazione Ca' Granda Ospedale Maggiore Policlinico
  More Information

Publications:
Additional 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
Study First Received: July 1, 2011
Last Updated: July 11, 2011
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health
Italy: National Institute of Health
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

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:
Infertility
Genital Diseases, Female
Genital Diseases, Male
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Chelating Agents
Estrogen Antagonists
Estrogen Receptor Modulators
Fertility Agents
Fertility Agents, Female
Hematologic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Sequestering Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014