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

Information source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility

Intervention: Clomifene Citrate (Drug); GnRH analog and recombinant human FSH (Drug)

Phase: N/A

Status: Completed

Sponsored by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Official(s) and/or principal investigator(s):
guido ragni, md, Principal Investigator, Affiliation: Fondazione Ca' Granda Ospedale Maggiore Policlinico

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).

Clinical Details

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: live birth rate

Secondary outcome: ratio pregnancies/costs

Eligibility

Minimum age: 18 Years. Maximum age: 42 Years. Gender(s): Female.

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

Locations and Contacts

Fondazione Ca' Granda Ospedale Maggiore Policlinico, Milan 20122, Italy
Additional Information

Related publications:

Heijnen EM, Eijkemans MJ, De Klerk C, Polinder S, Beckers NG, Klinkert ER, Broekmans FJ, Passchier J, Te Velde ER, Macklon NS, Fauser BC. A mild treatment strategy for in-vitro fertilisation: a randomised non-inferiority trial. Lancet. 2007 Mar 3;369(9563):743-9.

Eijkemans MJ, Heijnen EM, de Klerk C, Habbema JD, Fauser BC. Comparison of different treatment strategies in IVF with cumulative live birth over a given period of time as the primary end-point: methodological considerations on a randomized controlled non-inferiority trial. Hum Reprod. 2006 Feb;21(2):344-51. Epub 2005 Oct 20.

Starting date: September 2008
Last updated: July 11, 2011

Page last updated: August 23, 2015

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