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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00417157
Recruitment Status : Completed
First Posted : December 29, 2006
Last Update Posted : December 16, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
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)

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.

Study Type : Observational
Actual Enrollment : 135 participants
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
Study Start Date : January 2007
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Live birth per started cycle [ Time Frame: live birth ]

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

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00417157

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

Responsible Party: Eugonia Identifier: NCT00417157     History of Changes
Other Study ID Numbers: MNC
First Posted: December 29, 2006    Key Record Dates
Last Update Posted: December 16, 2013
Last Verified: December 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