NCT01389713

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
289

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 8, 2011

Completed
Last Updated

July 12, 2011

Status Verified

July 1, 2011

Enrollment Period

2.2 years

First QC Date

July 1, 2011

Last Update Submit

July 11, 2011

Conditions

Infertility

Keywords

ovarian reserveovarian stimulationclomifene citratehigh doses Follicle Stimulating Hormone (FSH)

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (1)

  • ratio pregnancies/costs

    end of the study (28 months)

Study Arms (2)

High doses

ACTIVE COMPARATOR

Administration of high doses of gonadotrophins to stimulate ovarian follicular growth

Drug: GnRH analog and recombinant human FSH

Clomid

EXPERIMENTAL

Administration of Clomiphene Citrate to obtain ovarian follicular growth

Drug: Clomifene Citrate

Interventions

Clomifene CitrateDRUG

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

Also known as: clomid
Clomid
GnRH analog and recombinant human FSHDRUG

daily subcutaneous 0.1 mg decapeptyl from day 1-2 of the menstrual cycle and recombinant human FSH 450 IU/die from day 3.

Also known as: decapeptyl, Gonal-F
High doses

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • contraindications to infertility treatments or pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Related Publications (3)

  • 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):743-749. doi: 10.1016/S0140-6736(07)60360-2.

    PMID: 17336650BACKGROUND

  • 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. doi: 10.1093/humrep/dei332. Epub 2005 Oct 20.

    PMID: 16239317BACKGROUND

  • Ragni G, Levi-Setti PE, Fadini R, Brigante C, Scarduelli C, Alagna F, Arfuso V, Mignini-Renzini M, Candiani M, Paffoni A, Somigliana E. Clomiphene citrate versus high doses of gonadotropins for in vitro fertilisation in women with compromised ovarian reserve: a randomised controlled non-inferiority trial. Reprod Biol Endocrinol. 2012 Dec 18;10:114. doi: 10.1186/1477-7827-10-114.

    PMID: 23249758DERIVED

MeSH Terms

Conditions

Infertility

Interventions

ClomipheneGonadotropin-Releasing HormoneTriptorelin Pamoatefollitropin alfa

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • guido ragni, md

    Fondazione Ca' Granda Ospedale Maggiore Policlinico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2011

First Posted

July 8, 2011

Study Start

September 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

July 12, 2011

Record last verified: 2011-07

Locations

IT(1)