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

Completed

• Conditions: Premature Ovarian Failure; Infertility

• Registration Number: NCT00417157
• Lead Sponsor: Eugonia

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.

Study Timeline

• Study First Submitted: 2006-12-22
• Study First Submitted QC: 2006-12-28
• Study First Posted: 2006-12-29
• Study Start: 2007-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-13
• Last Update Posted: 2013-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 135

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Live birth per started cycle	live birth

Secondary Outcome Measures

Name	Time	Method
Biochemical pregnancy per started cycle	positive hCG test 14 days post oocyte retrieval
Clinical pregnancy per started cycle	presence of fetal sac and heart beat at 7 weeks of gestation
Cycle cancellation rates	cycles not reaching oocyte retrieval
Ongoing pregnancy rates per started cycle	presence of fetal sac and heart beat at 12 weeks of gestation

Trial Locations

Locations (1)

Eugonia; 🇬🇷 Athens, Greece