Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-01-10 @ 1:04 PM
Study NCT ID:
NCT00417157
Status:
COMPLETED
Last Update Posted:
2013-12-16
First Post:
2006-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modified Natural Cycle Offers a Chance of Pregnancy in Patients With Poor Response and High Basal FSH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D016649', 'term': 'Primary Ovarian Insufficiency'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571802', 'term': 'follitropin beta'}, {'id': 'C061018', 'term': 'ganirelix'}, {'id': 'D006063', 'term': 'Chorionic Gonadotropin'}], 'ancestors': [{'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-13', 'studyFirstSubmitDate': '2006-12-22', 'studyFirstSubmitQcDate': '2006-12-28', 'lastUpdatePostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live birth per started cycle', 'timeFrame': 'live birth'}], 'secondaryOutcomes': [{'measure': 'Biochemical pregnancy per started cycle', 'timeFrame': 'positive hCG test 14 days post oocyte retrieval'}, {'measure': 'Clinical pregnancy per started cycle', 'timeFrame': 'presence of fetal sac and heart beat at 7 weeks of gestation'}, {'measure': 'Cycle cancellation rates', 'timeFrame': 'cycles not reaching oocyte retrieval'}, {'measure': 'Ongoing pregnancy rates per started cycle', 'timeFrame': 'presence of fetal sac and heart beat at 12 weeks of gestation'}]}, 'conditionsModule': {'keywords': ['GnRH antagonist', 'Poor responders', 'Oocyte donation', 'Modified natural cycle'], 'conditions': ['Infertility', 'Premature Ovarian Failure']}, 'referencesModule': {'references': [{'pmid': '15471941', 'type': 'BACKGROUND', 'citation': '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. doi: 10.1093/humrep/deh452. Epub 2004 Oct 7.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women undergoing IVF treatment', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Regular menstrual cycle (21-35 days)\n* Basal FSH\\>12 IU/ml\n* One or more failed IVF attempts (\\<3 oocyte retrieved)\n\nExclusion Criteria:\n\n* PCOS\n* Normal responders'}, 'identificationModule': {'nctId': 'NCT00417157', 'briefTitle': 'Modified Natural Cycle Offers a Chance of Pregnancy in Patients With Poor Response and High Basal FSH', 'organization': {'class': 'OTHER', 'fullName': 'Eugonia'}, 'officialTitle': 'Successful Application of Modified Natural Cycle in Poor Responders With High Basal FSH Prior to Oocyte Donation', 'orgStudyIdInfo': {'id': 'MNC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'recombinant FSH (Puregon, Organon, The Netherlands)', 'type': 'DRUG'}, {'name': 'GnRH antag: Ganirelix (Orgalutran, Organon, The Netherlands)', 'type': 'DRUG'}, {'name': 'hCG (Pregnyl, Organon, The Netherlands)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11528', 'city': 'Athens', 'country': 'Greece', 'facility': 'Eugonia', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Tryfon Lainas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eugonia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eugonia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}