Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-01-03 @ 11:05 AM
Study NCT ID:
NCT06725004
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2024-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxytocin Versus Human Chorionic Gonadotropin as Trigger in Ovulation Induction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}, {'id': 'D006063', 'term': 'Chorionic Gonadotropin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-23', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-05', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants having ovulation', 'timeFrame': '1 week', 'description': 'Number of participants having ovulation defined by findings on TVS after 36 hours and/or serum progesterone level 7th day after triggering'}], 'secondaryOutcomes': [{'measure': 'Number of participants having pregnancy', 'timeFrame': '3 weeks', 'description': 'Number of participants having pregnancy determined by urinary pregnancy kit test after missed period.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ovulation induction', 'Polycystic Ovary Syndrome', 'Oxytocin', 'Human Chorionic Gonadotropin (HCG)'], 'conditions': ['Ovulation Induction', 'Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '24359041', 'type': 'BACKGROUND', 'citation': 'Mehrotra S, Singh U, Gupta HP, Tandon I, Saxena P. A prospective double blind study comparing the effects of oxytocin and human chorionic gonadotrophin as trigger for ovulation. J Obstet Gynaecol. 2014 Jan;34(1):13-6. doi: 10.3109/01443615.2013.822479.'}, {'pmid': '24482059', 'type': 'BACKGROUND', 'citation': 'George K, Kamath MS, Nair R, Tharyan P. Ovulation triggers in anovulatory women undergoing ovulation induction. Cochrane Database Syst Rev. 2014 Jan 31;2014(1):CD006900. doi: 10.1002/14651858.CD006900.pub3.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if injection oxytocin can be used as trigger in ovulation induction cycles in infertile women with polycystic ovary syndrome. The main questions it aims to answer are:\n\n* Does injection oxytocin have similar ovulation rate as injection human chorionic gonadotropin (hCG) when used as trigger?\n* Does injection oxytocin have similar pregnancy rate as injection human chorionic gonadotropin (hCG) when used as trigger?\n\nResearchers will compare injection oxytocin to injection hCG to see if injection oxytocin is as effective as injection hCG as trigger in ovulation induction cycles in infertile women with polycystic ovary syndrome.\n\nParticipants will\n\n* Take injection oxytocin or injection hCG as trigger over three subsequent ovulation induction cycles\n* Be checked for ovulation by follicular rupture in TVS after 36 hours or raised serum progesterone level on day 7 after trigger\n* Be checked for pregnancy by urine pregnancy test kit after missed period', 'detailedDescription': 'This is an open label randomized controlled trial. After baseline transvaginal sonography (TVS), all the participants will be given tablet letrozole 5 mg or more from day 2 to day 6 of their menstrual cycle. Then participants will be followed up by TVS for follicular maturation and endometrial thickness.When the size of mature follicle will be at least 18mm , then participants will be randomized into experimental group and comparator group. The participants in experimental group will receive inj. (injection) oxytocin 10 IU (Inj. Linda 10 unit, Nuvista Pharmaceuticals Limited) intramuscular as trigger and the participants in control group received Inj. hCG 5000 IU (Inj. hCG 5000 IU, Popular Pharmaceuticals Limited) intramuscular as trigger. Participants will be followed up 36 hours after injection by TVS for follicular rupture. On the 7th day following oxytocin or hCG injection, serum progesterone level will be measured by chemiluminescent immunoassay . Participants will be followed until the next cycle for conception. If conception does not occur, then the procedure will be repeated in next cycle for 3 cycles.\n\nRandom sequence generation will be done by computer generated random numbers after permuted block randomization. Allocation concealment will be done by serially numbered closed envelops. Each envelop will be labeled with a serial number and has a card inside noting the intervention drug. A sample size of 24 in each group will be calculated to detect a non-inferiority margin difference between the group proportions with 80.9% power and the level of significance 0.05. Considering 10% patients drop out, 30 participants will be recruited in each group.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infertile women with polycystic ovary syndrome\n* Age less than 40 years\n* Had ovulation induction with letrozole, with at least one mature follicle detected on folliculometry\n\nExclusion Criteria:\n\n* Male factor abnormality\n* Bilateral tubal block\n* Any pelvic pathology like pelvic inflammatory diseases\n* Any uterine abnormality\n* Ovarian cysts\n* Any cardiovascular diseases or other systemic diseases\n* Hyperprolactinemia or thyroid dysfunction\n* Any drugs that affect the functions of hypothalamus, pituitary gland, and gonads\n* Any known hypersensitivity to oxytocin'}, 'identificationModule': {'nctId': 'NCT06725004', 'briefTitle': 'Oxytocin Versus Human Chorionic Gonadotropin as Trigger in Ovulation Induction', 'organization': {'class': 'OTHER', 'fullName': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}, 'officialTitle': 'Oxytocin Versus Human Chorionic Gonadotropin as Trigger in Ovulation Induction Cycles: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '4221'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oxytocin', 'description': 'Participants will receive injection oxytocin 10 mg intramuscular as trigger for ovulation induction', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Human Chorionic Gonadotropin', 'description': 'Participants will receive injection Human Chorionic Gonadotropin 5000 IU intramuscular as trigger for ovulation induction', 'interventionNames': ['Drug: Human Chorionic Gonadotropin']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'description': 'Injection Oxytocin 10 mg intramuscular as trigger for ovulation induction', 'armGroupLabels': ['Oxytocin']}, {'name': 'Human Chorionic Gonadotropin', 'type': 'DRUG', 'description': 'Injection Human Chorionic Gonadotropin 5000 IU intramuscular as trigger for ovulation induction', 'armGroupLabels': ['Human Chorionic Gonadotropin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Dhaka', 'state': 'Dhaka Division', 'country': 'Bangladesh', 'facility': 'Bangabandhu Sheikh Mujib Medical University', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'overallOfficials': [{'name': 'Shakeela Ishrat, FCPS,MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bangladesh Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shakeela Ishrat', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shakeela Ishrat', 'investigatorAffiliation': 'Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh'}}}}