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

Infertility Clinical Trial

Official title:

Successful Application of Modified Natural Cycle in Poor Responders With High Basal FSH Prior to Oocyte Donation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417157
• Other study ID #: MNC
• Status: Completed
• Phase: Phase 4
• First received: December 22, 2006
• Last updated: December 13, 2013
• Start date: January 2007
• Est. completion date: December 2012

Study information

• Verified date: December 2013
• Source: Eugonia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility
• Menopause, Premature
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Drug:
• recombinant FSH (Puregon, Organon, The Netherlands)

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

• hCG (Pregnyl, Organon, The Netherlands)

Locations

Country	Name	City	State
Greece	Eugonia	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Eugonia

Country where clinical trial is conducted

Greece, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth per started cycle		live birth	No
Secondary	Biochemical pregnancy per started cycle		positive hCG test 14 days post oocyte retrieval	No
Secondary	Clinical pregnancy per started cycle		presence of fetal sac and heart beat at 7 weeks of gestation	No
Secondary	Cycle cancellation rates		cycles not reaching oocyte retrieval	No
Secondary	Ongoing pregnancy rates per started cycle		presence of fetal sac and heart beat at 12 weeks of gestation	No