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Modified Natural Cycle Offers a Chance of Pregnancy in Patients With Poor Response to IVF Drugs

This study is ongoing, but not recruiting participants.

Sponsored by: Eugonia
Information provided by: Eugonia
ClinicalTrials.gov Identifier: NCT00417157
  Purpose

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


Condition Intervention Phase
Infertility
Premature Ovarian Failure
Drug: recombinant FSH (Puregon, Organon, The Netherlands)
Drug: GnRH antag: Ganirelix (Orgalutran, Organon, The Netherlands)
Drug: hCG (Pregnyl, Organon, The Netherlands)
Phase IV

MedlinePlus related topics:   Infertility    Premature Ovarian Failure   

Drug Information available for:   Follitropin beta    Urofollitropin    Chorionic gonadotropin    Choriogonadotropin Alfa    Gonadorelin    Gonadorelin hydrochloride    LH-RH    Ganirelix acetate    Ganirelix   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:   Successful Application of Modified Natural Cycle in Poor Responders Prior to Oocyte Donation

Further study details as provided by Eugonia:

Primary Outcome Measures:
  • Ongoing pregnancy per embryo transfer

Secondary Outcome Measures:
  • Biochemical pregnancy per embryo transfer
  • Clinical pregnancy per embryo transfer
  • Number of oocytes collected

Estimated Enrollment:   48
Study Start Date:   October 2003
Estimated Study Completion Date:   November 2006

Detailed Description:

Poor responders are a diverse group of IVF patients who fail to respond to IVF drugs. In these patients pregnancy rates remain disappointingly low and usually oocyte donation is their only viable option. The need for lengthy ovarian stimulation regimes can be avoided by performing IVF during a natural menstrual cycle. However, the main problem with a natural cycle is that successful IVF outcome can be compromised by a premature LH surge. This problem can be solved by the administration of GnRH antagonists that suppress endogenous gonadotropin levels, comprising a modified natural cycle (MNC). Previous studies have shown that MNC offers no realistic chances of pregnancy prior to oocyte donation. In this study we will re-assess this view by showing that MNC offers some, albeit small, chances of positive IVF outcome in patients with known previous poor response prior to oocyte donation.

  Eligibility
Ages Eligible for Study:   30 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • PCOS
  • Normal responders
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417157

Locations
Greece
Eugonia    
      Athens, Greece, 11528

Sponsors and Collaborators
Eugonia

Investigators
Principal Investigator:     Tryfon Lainas, PhD     Eugonia    
  More Information


Publications:

Study ID Numbers:   MNC
First Received:   December 22, 2006
Last Updated:   December 28, 2006
ClinicalTrials.gov Identifier:   NCT00417157
Health Authority:   Greece: National Organization of Medicines

Keywords provided by Eugonia:
GnRH antagonist  
Poor responders  
Oocyte donation  
Modified natural cycle  

Study placed in the following topic categories:
Genital Diseases, Female
Infertility
Ganirelix
Gonadal Disorders
Endocrine System Diseases
Ovarian Failure, Premature
Endocrinopathy
Ovarian Diseases
Chorionic Gonadotropin
Genital Diseases, Male

Additional relevant MeSH terms:
Adnexal Diseases

ClinicalTrials.gov processed this record on October 22, 2008




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