NCT02237755

Brief Summary

Coadministration of various drugs used for ovarian stimulation can increase the efficiency of IVF especially in poor responders. The investigators hypothesize that ovarian response of those patients could improve by using combination of clomiphene citrate with gonadotropins in infertile women with poor response to gonadotrophin administration only.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_2

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

1 month

First QC Date

September 9, 2014

Last Update Submit

September 9, 2014

Conditions

Female Infertility

Keywords

Clomiphene citrateIVFPregnancy RatesOvarian Reserve

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy

    At the completion of the ovarian stimulation patients that will proceed to transfer and have a positive pregnancy test will have sonographic evaluation for confirmation of clinical pregnancy.

    14 days after embryo transfer

Study Arms (2)

Clomiphene citrate

ACTIVE COMPARATOR

Administration of Clomiphene citrate in combination with gonadotropins according to a short stimulation GnRH antagonists protocol.

Drug: Clomiphene citrateDrug: Gonadotropins

Gonadotropins

ACTIVE COMPARATOR

Patients in this group will be stimulated according to a short stimulation protocol with gonadotropins and GnRH antagonists.

Drug: Clomiphene citrateDrug: Gonadotropins

Interventions

Clomiphene citrateDRUG

clomiphene citrate 100mg/day will be added to the standard gonadotropin regiment

Also known as: Clomiphene citrate 50 mg/tab, Cerpafar 50 mg/tab
Clomiphene citrateGonadotropins
GonadotropinsDRUG

All patients will be stimulated with a fixed GnRH-antagonist protocol. Ovarian stimulation will be initiated with 450 IU of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH.

Also known as: Menopur 75IU , Gonal
Clomiphene citrateGonadotropins

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women with poor response to ovarian stimulation. The definition of poor response was based on the presence of at least one of the following criteria: Age \> 40 years old, day 2 FSH \>9.5 mIU/ml, AMH \< 2ng/ml ,at least one previous COH with less than 3 oocytes retrieved, at least one cancelled attempt due to poor response, estradiol less than 500 pg/ml on the day of HCG.

You may not qualify if:

  • All other women that do not fulfill the above mentioned criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Female

Interventions

ClomipheneGonadotropinsMenotropins

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsGonadotropins, PituitaryPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and ProteinsBiological ProductsComplex Mixtures

Study Officials

  • Nikos Vlahos, Assoc. Prof.

    University of Athens, 2nd Department of Obstetrics and Gynecology

    STUDY CHAIR

  • Olga Triantafyllidou, MD

    University of Athens School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikos Vlahos, MD

CONTACT

30 210 7286000nikosvlahos@med.uoa.gr

Olga Triantafyllidou, MD

CONTACT

30 2107485591triantafyllidouolga@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Obstetrics and Gynecology

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 11, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2014

Study Completion

December 1, 2015

Last Updated

September 11, 2014

Record last verified: 2014-09