DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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 cycle

Clinical 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.


Minimum age: 20 Years. Maximum age: 50 Years. Gender(s): Female.


Inclusion Criteria:

- Regular menstrual cycle (21-35 days)

- Basal FSH>12 IU/ml

- One or more failed IVF attempts (<3 oocyte retrieved)

Exclusion Criteria:


- 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017