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

NCT01389713 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 289

Last updated 2011-07-12

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Clomifene Citrate

3x50 mg die for 5 days from day 3 to day 7 of the menstrual cycle

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.

Sponsors & Collaborators

  • Istituto Clinico Humanitas

    collaborator OTHER

  • IRCCS San Raffaele

    collaborator OTHER

  • Istituti Clinici Zucchi

    collaborator OTHER

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • guido ragni, md · Fondazione Ca' Granda Ospedale Maggiore Policlinico

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01389713 on ClinicalTrials.gov