Modified Natural Cycle Offers a Chance of Pregnancy in Patients With Poor Response and High Basal FSH

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eugonia
ClinicalTrials.gov Identifier:
NCT00417157
First received: December 22, 2006
Last updated: December 13, 2013
Last verified: December 2013
  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 and high basal FSH, 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: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Successful Application of Modified Natural Cycle in Poor Responders With High Basal FSH Prior to Oocyte Donation

Resource links provided by NLM:


Further study details as provided by Eugonia:

Primary Outcome Measures:
  • Live birth per started cycle [ Time Frame: live birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical pregnancy per started cycle [ Time Frame: positive hCG test 14 days post oocyte retrieval ] [ Designated as safety issue: No ]
  • Clinical pregnancy per started cycle [ Time Frame: presence of fetal sac and heart beat at 7 weeks of gestation ] [ Designated as safety issue: No ]
  • Cycle cancellation rates [ Time Frame: cycles not reaching oocyte retrieval ] [ Designated as safety issue: No ]
  • Ongoing pregnancy rates per started cycle [ Time Frame: presence of fetal sac and heart beat at 12 weeks of gestation ] [ Designated as safety issue: No ]

Enrollment: 135
Study Start Date: January 2007
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women undergoing IVF treatment

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Responsible Party: Eugonia
ClinicalTrials.gov Identifier: NCT00417157     History of Changes
Other Study ID Numbers: MNC
Study First Received: December 22, 2006
Last Updated: December 13, 2013
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

ClinicalTrials.gov processed this record on September 22, 2014