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

December 13, 2013 updated by: Eugonia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Observational

Enrollment (Actual)

135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11528
        • Eugonia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women undergoing IVF treatment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Live birth per started cycle
Time Frame: live birth
live birth

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eugonia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

December 22, 2006

First Submitted That Met QC Criteria

December 28, 2006

First Posted (ESTIMATE)

December 29, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

December 16, 2013

Last Update Submitted That Met QC Criteria

December 13, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MNC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on recombinant FSH (Puregon, Organon, The Netherlands)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe