NCT00417157

Brief Summary

The purpose of this study is to evaluate the effectiveness of a modified natural cycle in patients with previous poor response to infertility drugs and high basal FSH, prior to proceeding to oocyte donation or abandoning fertility treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

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

First Submitted

Initial submission to the registry

December 22, 2006

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 29, 2006

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 16, 2013

Status Verified

December 1, 2013

Enrollment Period

5.9 years

First QC Date

December 22, 2006

Last Update Submit

December 13, 2013

Conditions

InfertilityPremature Ovarian Failure

Keywords

GnRH antagonistPoor respondersOocyte donationModified natural cycle

Outcome Measures

Primary Outcomes (1)

  • Live birth per started cycle

    live birth

Secondary Outcomes (4)

  • Biochemical pregnancy per started cycle

    positive hCG test 14 days post oocyte retrieval

  • Clinical pregnancy per started cycle

    presence of fetal sac and heart beat at 7 weeks of gestation

  • Cycle cancellation rates

    cycles not reaching oocyte retrieval

  • Ongoing pregnancy rates per started cycle

    presence of fetal sac and heart beat at 12 weeks of gestation

Interventions

recombinant FSH (Puregon, Organon, The Netherlands)DRUG
GnRH antag: Ganirelix (Orgalutran, Organon, The Netherlands)DRUG
hCG (Pregnyl, Organon, The Netherlands)DRUG

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women undergoing IVF treatment

You may qualify if:

  • Regular menstrual cycle (21-35 days)
  • Basal FSH\>12 IU/ml
  • One or more failed IVF attempts (\<3 oocyte retrieved)

You may not qualify if:

  • PCOS
  • Normal responders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eugonia

Athens, 11528, Greece

Location

Related Publications (1)

  • Kolibianakis E, Zikopoulos K, Camus M, Tournaye H, Van Steirteghem A, Devroey P. Modified natural cycle for IVF does not offer a realistic chance of parenthood in poor responders with high day 3 FSH levels, as a last resort prior to oocyte donation. Hum Reprod. 2004 Nov;19(11):2545-9. doi: 10.1093/humrep/deh452. Epub 2004 Oct 7.

    PMID: 15471941BACKGROUND

MeSH Terms

Conditions

InfertilityPrimary Ovarian Insufficiency

Interventions

follitropin betaganirelixChorionic Gonadotropin

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteins

Study Officials

  • Tryfon Lainas, PhD

    Eugonia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2006

First Posted

December 29, 2006

Study Start

January 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 16, 2013

Record last verified: 2013-12

Locations

GR(1)