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

NCT ID: NCT00417157

Last Updated: 2013-12-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 135 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2012-12-31

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.

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.

Conditions

Infertility; Premature Ovarian Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

recombinant FSH (Puregon, Organon, The Netherlands)

Intervention Type: DRUG

GnRH antag: Ganirelix (Orgalutran, Organon, The Netherlands)

Intervention Type: DRUG

hCG (Pregnyl, Organon, The Netherlands)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eugonia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tryfon Lainas, PhD

Role: PRINCIPAL_INVESTIGATOR

Eugonia

Locations

Eugonia

Athens, , Greece

Countries

Greece

References

Kolibianakis E, Zikopoulos K, Camus M, Tournaye H, Van Steirteghem A, Devroey P. Modified natural cycle for IVF does not offer a realistic chance of parenthood in poor responders with high day 3 FSH levels, as a last resort prior to oocyte donation. Hum Reprod. 2004 Nov;19(11):2545-9. doi: 10.1093/humrep/deh452. Epub 2004 Oct 7.

Reference Type: BACKGROUND

PMID: 15471941 (View on PubMed)

Other Identifiers

MNC

Identifier Type: -

Identifier Source: org_study_id