- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00417157
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
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
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Athens, Greece, 11528
- Eugonia
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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
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live birth
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biochemical pregnancy per started cycle
Time Frame: positive hCG test 14 days post oocyte retrieval
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positive hCG test 14 days post oocyte retrieval
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Clinical pregnancy per started cycle
Time Frame: presence of fetal sac and heart beat at 7 weeks of gestation
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presence of fetal sac and heart beat at 7 weeks of gestation
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Cycle cancellation rates
Time Frame: cycles not reaching oocyte retrieval
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cycles not reaching oocyte retrieval
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Ongoing pregnancy rates per started cycle
Time Frame: presence of fetal sac and heart beat at 12 weeks of gestation
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presence of fetal sac and heart beat at 12 weeks of gestation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Infertility
- Primary Ovarian Insufficiency
- Menopause, Premature
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Reproductive Control Agents
- Chorionic Gonadotropin
- Ganirelix
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.
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