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

Infertility Clinical Trial

— clomid  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389713
• Other study ID #: clomid re-007
• Status: Completed
• Phase: N/A
• First received: July 1, 2011
• Last updated: July 11, 2011
• Start date: September 2008
• Est. completion date: December 2010

Study information

• Verified date: July 2011
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: Ministry of HealthItaly: National Institute of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Clomifene Citrate
3x50 mg die for 5 days from day 3 to day 7 of the menstrual cycle
• 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.

Locations

Country	Name	City	State
Italy	Fondazione Ca' Granda Ospedale Maggiore Policlinico	Milan

Sponsors (4)

Lead Sponsor	Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico	IRCCS San Raffaele, Istituti Clinici ZUcchi, Monza, Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live birth rate	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)	No
Secondary	ratio pregnancies/costs	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)	No