Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-01-05 @ 5:15 PM
Study NCT ID:
NCT03240159
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2017-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Antagonist Protocol for IVF With Single Luteal Dose of Degarelix
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065172', 'term': 'Pregnancy, Ovarian'}], 'ancestors': [{'id': 'D011271', 'term': 'Pregnancy, Ectopic'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C431566', 'term': 'acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2017-08-02', 'studyFirstSubmitQcDate': '2017-08-03', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LH levels', 'timeFrame': '4 days after injection of Degarelix', 'description': 'Effectively down regulation of follicular LH levels (\\<14mIU/ml)/'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy, Ovarian']}, 'referencesModule': {'references': [{'pmid': '29545772', 'type': 'DERIVED', 'citation': 'Papanikolaou EG, Yarali H, Timotheou E, Grynberg M, Zafeiratis O, Tournaye H, Najdecki R. A Proof-of-Concept Clinical Trial of A Single Luteal Use of Long-Acting Gonadotropin-Releasing Hormone Antagonist Degarelix in Controlled Ovarian Stimulation for In Vitro Fertilization: Long Antagonist Protocol. Front Endocrinol (Lausanne). 2018 Mar 1;9:25. doi: 10.3389/fendo.2018.00025. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'A prospective study of three different doses of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF', 'detailedDescription': 'A prospective study of three different doses of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF:Single dose of Degarelix 24mg, 16mg and 12 mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.\n\nON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.\n\nOn day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.\n\nOn day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.\n\nOn day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* primary infertility\n* age 18-39 years; body mass index (BMI) 18-29kg/m2;\n* regular menstrual cycle of 26-35days,\n* presumed to be ovulatory;\n* early follicular- phase serum concentration of FSH within normal limits (1-12 IU/l).\n\nExclusion Criteria:\n\n* women with diabetes and other metabolic disease\n* women with heart disease, QT prolongation,heart failure\n* elevated liver enzymes, liver failure, hepatitis\n* women with inflammatory or autoimmune disease\n* abnormal karyotype;\n* polycystic ovarian syndrome,\n* endometriosis stage III/IV;\n* history of being a 'poor responder',\n* defined as \\>20 days of gonadotrophin in a previous stimulation cycle, or any previous cancellation of a stimulation cycle due to limited follicular response, or development of less than 4 follicles 15 mm in a previous stimulation cycle; history of recurrent miscarriage; severe OHSS in a previous stimula- tion cycle or any contraindication for the use of gonadotrophins."}, 'identificationModule': {'nctId': 'NCT03240159', 'briefTitle': 'Long Antagonist Protocol for IVF With Single Luteal Dose of Degarelix', 'organization': {'class': 'OTHER', 'fullName': 'Assisting Nature'}, 'officialTitle': 'Long Antagonist Protocol for IVF: a Proof of Concept for a Single Luteal GnRH- Antagonist Protocol', 'orgStudyIdInfo': {'id': 'Degarelix-AN003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Deg-24mg', 'description': 'Single dose of Degarelix 24mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.\n\nON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.\n\nOn day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.\n\nOn day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.\n\nOn day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.', 'interventionNames': ['Drug: Degarelix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Deg-16mg', 'description': 'Single dose of Degarelix 16mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.\n\nON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.\n\nOn day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.\n\nOn day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.\n\nOn day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.', 'interventionNames': ['Drug: Degarelix']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Deg-12mg', 'description': 'Single dose of Degarelix 12mg, on day 24th of previous luteal face cycle.On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.\n\nON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.\n\nOn day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.\n\nOn day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.\n\nOn day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.', 'interventionNames': ['Drug: Degarelix']}], 'interventions': [{'name': 'Degarelix', 'type': 'DRUG', 'description': 'Degarelix 24mg Degarelix 16mg Degarelix 12mg\n\nActive Comparator:\n\nDown regulation of LH, during exposing in three different doses of Degarelix', 'armGroupLabels': ['Deg-12mg', 'Deg-16mg', 'Deg-24mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57001', 'city': 'Thessaloniki', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Robert Najdecki, MD, PhD', 'role': 'CONTACT', 'email': 'rnajdecki@assistingnature.gr', 'phone': '6936646464'}, {'name': 'Najdecki', 'role': 'CONTACT'}], 'facility': 'Assisting Nature', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'centralContacts': [{'name': 'Evaggelos Papanikolaou, MD, PhD', 'role': 'CONTACT', 'email': 'drvagpapanikolaou@yahoo.gr', 'phone': '00302310424294'}], 'overallOfficials': [{'name': 'Evaggelos Papanikolaou, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assisting Nature'}, {'name': 'Robert Najdecki, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assisting Nature'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assisting Nature', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Papanikolaou Evaggelos, MD, PhD', 'investigatorFullName': 'Papanikolaou Evaggelos', 'investigatorAffiliation': 'Assisting Nature'}}}}