Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:49 AM
Study NCT ID:
NCT07379502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-30
First Post:
2025-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endometrial Response in Polycystic Ovarian Syndrome Treated With Letrozole Alone or With Added Estradiol Valerate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'D000077289', 'term': 'Letrozole'}, {'id': 'D047072', 'term': 'Aromatase Inhibitors'}, {'id': 'D004958', 'term': 'Estradiol'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D065088', 'term': 'Steroid Synthesis Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004965', 'term': 'Estrogen Antagonists'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-27', 'studyFirstSubmitDate': '2025-11-26', 'studyFirstSubmitQcDate': '2026-01-27', 'lastUpdatePostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endometrial thickness (mm) on day of ovulation trigger', 'timeFrame': '12th day of cycle 1 (Each cycle is 28 days)', 'description': 'Endometrial thickness will be measured on Transvaginal ultrasound on 12th day in a 28 day menstrual cycle.'}, {'measure': 'Pattern of endometrium (Trilaminar or Non-trilaminar) on the day of ovulation trigger', 'timeFrame': '12th day of cycle 1 (Each cycle is 28 days)', 'description': 'Endometrial pattern will be seen on Transvaginal ultrasound on 12th day in a 28 day menstrual cycle'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PCOS (Polycystic Ovary Syndrome)', 'Letrozole', 'Estradiol Valerate', 'Endometrial response', 'Endometrial thickness'], 'conditions': ['PCOS (Polycystic Ovary Syndrome)']}, 'descriptionModule': {'briefSummary': 'Polycystic Ovary Syndrome (PCOS) is one of the most common endocrine disorders among women of reproductive age, characterized by chronic anovulation, hyperandrogenism, and polycystic ovarian morphology. Letrozole, an aromatase inhibitor, has emerged as a first-line ovulation induction agent due to its superior ovulation and pregnancy rates compared to clomiphene citrate. Estradiol valerate, a synthetic estrogen, can be co-administered with letrozole to improve endometrial receptivity by enhancing endometrial thickness, vascularity, and pattern. This study aims to evaluate the effect of letrozole alone versus letrozole with estradiol valerate on endometrial development in these patients.', 'detailedDescription': 'Polycystic Ovary Syndrome (PCOS) is one of the most common endocrine disorders among women of reproductive age, characterized by chronic anovulation, hyperandrogenism, and polycystic ovarian morphology. Letrozole, an aromatase inhibitor, has emerged as a first-line ovulation induction agent due to its superior ovulation and pregnancy rates compared to clomiphene citrate. However, one of the drawbacks of aromatase inhibitors is suboptimal endometrial development, which may adversely affect implantation and pregnancy outcomes.\n\nEstradiol valerate, a synthetic estrogen, can be co-administered with letrozole to improve endometrial receptivity by enhancing endometrial thickness, vascularity, and pattern. Limited data exist on whether adding estradiol to letrozole truly improves the endometrial response and clinical pregnancy rates in women with PCOS. This study aims to evaluate the effect of letrozole alone versus letrozole with estradiol valerate on endometrial development in these patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 20-35 years\n* Clinical diagnosis of PCOS (Rotterdam criteria)\n\nExclusion Criteria:\n\n* Endocrine disorders other than PCOS\n* Endometrial pathology or uterine malformations\n* Allergy to letrozole or estradiol\n* Hormonal therapy within last 3 months'}, 'identificationModule': {'nctId': 'NCT07379502', 'briefTitle': 'Endometrial Response in Polycystic Ovarian Syndrome Treated With Letrozole Alone or With Added Estradiol Valerate', 'organization': {'class': 'OTHER_GOV', 'fullName': 'CMH Kharian Medical College'}, 'officialTitle': 'Endometrial Response in Women With Poorly Primed Endometrial Lining in Diagnosed Polycystic Ovarian Syndrome Treated With Letrozole Alone or With Added Estradiol Valerate', 'orgStudyIdInfo': {'id': 'CKMC/IERB/AC-00256'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'letrozole', 'description': '30 participants with PCOs will receive tab letrozole 2.5mg 2 x OD for 5 days', 'interventionNames': ['Drug: Letrozole (Aromatase Inhibitors)']}, {'type': 'EXPERIMENTAL', 'label': 'letrozole plus estradiol valerate', 'description': '30 participants with PCOs will receive tab letrozole 2.5mg 2 x OD for 5 days plus tab Estradiol valerate 2mg OD for 12 days', 'interventionNames': ['Drug: Letrozole (Aromatase Inhibitors) + Estradiol valerate']}], 'interventions': [{'name': 'Letrozole (Aromatase Inhibitors)', 'type': 'DRUG', 'description': '30 participants with PCOs will receive tab letrozole 2.5mg 2 x OD for 5 days', 'armGroupLabels': ['letrozole']}, {'name': 'Letrozole (Aromatase Inhibitors) + Estradiol valerate', 'type': 'DRUG', 'description': '30 participants with PCOs will receive tab letrozole 2.5mg 2 x OD for 5 days plus tab Estradiol valerate 2mg OD for 12 days', 'armGroupLabels': ['letrozole plus estradiol valerate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50070', 'city': 'Khārian', 'state': 'Punjab Province', 'country': 'Pakistan', 'contacts': [{'name': 'Maryum Noor Malik, MBBS, FCPS, CHPE', 'role': 'CONTACT', 'email': 'maryam.n.malik24@gmail.com', 'phone': '+923111777089'}, {'name': 'Mushayada Irshad, MBBS, Mphil, CHPE', 'role': 'CONTACT', 'email': 'mishy2360@gmail.com', 'phone': '+923237088421'}, {'name': 'Maryum Noor Malik, MBBS, FCPS, CHPE', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mugheera Hussain, MBBS, FCPS, MRCPI', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CMH Kharian Medical College'}], 'centralContacts': [{'name': 'Maryum Noor Malik, MBBS, FCPS, CHPE', 'role': 'CONTACT', 'email': 'maryam.n.malik24@gmail.com', 'phone': '+923111777089'}, {'name': 'Mushayada Irshad, MBBS, Mphil, CHPE', 'role': 'CONTACT', 'email': 'mishy2360@gmail.com', 'phone': '+923237088421'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CMH Kharian Medical College', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Registrar Ob/Gyn', 'investigatorFullName': 'Maryum Noor Malik', 'investigatorAffiliation': 'CMH Kharian Medical College'}}}}