Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT04846218
Status:
COMPLETED
Last Update Posted:
2021-11-18
First Post:
2016-12-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Agonist Trigger With HCG Luteal Supplementation vs HCG Trigger With Progesterone Luteal Supplementation in Antagonist Controlled HyperstimulationCycle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D017329', 'term': 'Triptorelin Pamoate'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-17', 'studyFirstSubmitDate': '2016-12-31', 'studyFirstSubmitQcDate': '2021-04-12', 'lastUpdatePostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '1 year', 'description': 'Clinical pregnancy diagnosed by pregnancy test and ultrasound'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': 'The aim of the current study is to compare agonist trigger and HCG luteal support vs standard HCG trigger and progesterone luteal supplementation in antagonist controlled hyperstimulation cycle as regards to clinical pregnancy rate.', 'detailedDescription': 'Prospective Interventional randomized pilotstudy on patients undergoing controlled ovarian hyperstimulation.\n\nAll patients will receive a fixed dose of 150-300 IU recombinant FSH (Gonal-F; Sereno Laboratories,Madrid, Spain) for ovarian stimulation according to age, BMI and antral follicle count (AFC).\n\nAfter 6 days of stimulation, FSH will be adjusted according to ovarian response.\n\nPremature LH surge will be prevented with 0.25 mg of a GnRH antagonist (Cetrotide; Serono International, Geneva, Switzerland) starting on day 6 when two or more follicles reach a size of 18-20 mm, trigger of ovulation will be done and followed by luteal phase support according to the protocol assigned for each group.\n\nGroup 1:\n\nA single dose of 0.2 mg triptorelin (Decapeptyl® Ipsen Pharmaceutical Company, France) and follow up with daily 125 IU HCG injections\n\nGroup 2:\n\nA single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg IM (Prontogest®).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 20 and 39 years.\n* Body mass index between 18 and 30.\n* Unexplained infertility or male factor infertility\n\nExclusion Criteria:\n\n* Endocrinological disorder eg.:hyperprolactenemia, Hypo or hyper thyrodism\n* More than 2 previous attemptsof IVF\n* Any uterine anatomical anomaly.'}, 'identificationModule': {'nctId': 'NCT04846218', 'briefTitle': 'Agonist Trigger With HCG Luteal Supplementation vs HCG Trigger With Progesterone Luteal Supplementation in Antagonist Controlled HyperstimulationCycle', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Comparison Between Agonist Trigger With HCG Luteal Phase Supplementation vs HCG Trigger With Progesterone Luteal Phase Supplementation in Antagonist Controlled HyperstimulationCycle Regarding Clinical Pregnancy Rate', 'orgStudyIdInfo': {'id': 'AP-45WE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'They will receive a single dose of 0.2 mg triptorelin (Decapeptyl® Ipsen Pharmaceutical Company, France) and follow up with daily 125 IU HCG injections', 'interventionNames': ['Drug: hCG', 'Drug: Triptorelin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'They will receive a single dose of HCG 10000 IU was given followed by progesterone supplementation with 100mg IM (Prontogest®).', 'interventionNames': ['Drug: hCG', 'Drug: Progesterone']}], 'interventions': [{'name': 'hCG', 'type': 'DRUG', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Progesterone', 'type': 'DRUG', 'otherNames': ['Prontogest'], 'armGroupLabels': ['Group 2']}, {'name': 'Triptorelin', 'type': 'DRUG', 'otherNames': ['Decapeptyl'], 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'AinShams Maternity Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'maii medhat nawara', 'investigatorAffiliation': 'Ain Shams University'}}}}