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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Eugonia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Eugonia
ClinicalTrials.gov Identifier:
NCT00417157
First received: December 22, 2006
Last updated: December 28, 2006
Last verified: December 2006
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Successful Application of Modified Natural Cycle in Poor Responders Prior to Oocyte Donation

Resource links provided by NLM:

U.S. FDA Resources

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:

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

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

Additional relevant MeSH terms:
Infertility
Menopause, Premature
Primary Ovarian Insufficiency
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
 Gonadal Disorders
Endocrine System Diseases
Ganirelix
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013