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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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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

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Infertility Premature Ovarian Failure

Keywords

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GnRH antagonist Poor responders Oocyte donation Modified natural cycle

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

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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

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Eugonia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tryfon Lainas, PhD

Role: PRINCIPAL_INVESTIGATOR

Eugonia

Locations

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Eugonia

Athens, , Greece

Site Status

Countries

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Greece

References

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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

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MNC

Identifier Type: -

Identifier Source: org_study_id