Modified Natural Cycle Offers a Chance of Pregnancy in Patients With Poor Response and High Basal FSH
Information source: Eugonia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infertility; Premature Ovarian Failure
Intervention: recombinant FSH (Puregon, Organon, The Netherlands) (Drug); GnRH antag: Ganirelix (Orgalutran, Organon, The Netherlands) (Drug); hCG (Pregnyl, Organon, The Netherlands) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Eugonia Official(s) and/or principal investigator(s): Tryfon Lainas, PhD, Principal Investigator, Affiliation: Eugonia
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.
Clinical Details
Official title: Successful Application of Modified Natural Cycle in Poor Responders With High Basal FSH Prior to Oocyte Donation
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Live birth per started cycle
Secondary outcome: Biochemical pregnancy per started cycleClinical pregnancy per started cycle Cycle cancellation rates Ongoing pregnancy rates per started cycle
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
Minimum age: 20 Years.
Maximum age: 50 Years.
Gender(s): Female.
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
Locations and Contacts
Eugonia, Athens 11528, Greece
Additional Information
Related publications: 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. Epub 2004 Oct 7.
Starting date: January 2007
Last updated: December 13, 2013
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