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

This study has been completed.
Information provided by (Responsible Party):
Eugonia Identifier:
First received: December 22, 2006
Last updated: December 13, 2013
Last verified: December 2013
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
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 ]

Secondary Outcome Measures:
  • Biochemical pregnancy per started cycle [ Time Frame: positive hCG test 14 days post oocyte retrieval ]
  • Clinical pregnancy per started cycle [ Time Frame: presence of fetal sac and heart beat at 7 weeks of gestation ]
  • Cycle cancellation rates [ Time Frame: cycles not reaching oocyte retrieval ]
  • Ongoing pregnancy rates per started cycle [ Time Frame: presence of fetal sac and heart beat at 12 weeks of gestation ]

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.

Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women undergoing IVF treatment

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
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Please refer to this study by its identifier: NCT00417157

Athens, Greece, 11528
Sponsors and Collaborators
Principal Investigator: Tryfon Lainas, PhD Eugonia
  More Information

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

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

Additional relevant MeSH terms:
Primary Ovarian Insufficiency
Menopause, Premature
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Chorionic Gonadotropin
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents processed this record on April 25, 2017