Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-01-04 @ 9:34 AM
Study NCT ID:
NCT05545592
Status:
RECRUITING
Last Update Posted:
2022-09-19
First Post:
2022-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduced Oestrogen Dosage to Improve the Outcome of Frozen-thawed Embryo Transfer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 660}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2022-09-15', 'studyFirstSubmitQcDate': '2022-09-15', 'lastUpdatePostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '45 days after embryo transfer', 'description': 'Clinical pregnancy is defined as the presence of gestational sac observed by ultrasound. The proportion of clinical pregnancy cycles to total FET cycles is the clinical pregnancy rate.'}], 'secondaryOutcomes': [{'measure': 'Embryo implantation rate', 'timeFrame': '45 days after embryo transfer', 'description': 'The proportion of the number of implanted embryos to the total number of transferred embryos is the embryo implantation rate.'}, {'measure': 'Early pregnancy loss rate', 'timeFrame': '12 weeks after embryo transfer', 'description': 'The early pregnancy loss rate refers to the proportion of patients with pregnancy loss before 12 weeks of gestation in the total clinical pregnancy patients.'}, {'measure': 'Incidence of thrombosis', 'timeFrame': '12 weeks after embryo transfer', 'description': 'Thrombosis incidence refers to the proportion of patients with deep venous thrombosis in the total patients.'}, {'measure': 'Incidence rate of gestational hypertension', 'timeFrame': '45 weeks after embryo transfer', 'description': 'The incidence rate of gestational hypertension refers to the proportion of patients with gestational hypertension in the total pregnant patients.'}, {'measure': 'Premature birth rate', 'timeFrame': '41 weeks after embryo transfer', 'description': 'Preterm birth rate refers to the proportion of patients with preterm birth in all pregnancies.'}, {'measure': 'Proportion of low birth weight infants', 'timeFrame': '41 weeks after embryo transfer', 'description': 'The proportion of low birth weight infants refers to the proportion of low birth weight infants in all newborns.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['FET']}, 'descriptionModule': {'briefSummary': 'This study is a single-center, randomized, controlled prospective study. Those who will recieve hormone replacement therapy-frozen thawed embryo transfer (HRT-FET) are enrolled in the study. To determine the effect of oestrogen dosage reducion on maternal and fetal complications in HRT-FET cycles while maintaining the similar clinical pregnancy outcome in HRT-FET cycles with regular oestrogen dosage.', 'detailedDescription': 'According to the enrollment and exclusion criteria, the patients were enrolled, and the subjects were randomly divided into two groups by computer randomization. Group A was the reduced oestrogen dosage group (test group). Group B was the regular hormone replacement group (control group).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Female;\n2. Aged between 20 and 40 years old;\n3. Frozen thawed embryo transfer is proposed, and the type of transferred embryo is blastocyst (the number of transferred embryos is 1);\n4. Body mass index (BMI) ≤ 28 kg/m2, ≥ 18.5 kg/m2;\n5. The total number of transfer cycles was \\< 3;\n6. Volunteer to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n1. Patients with chromosomal abnormalities;\n2. Contraindications to hormone replacement therapy;\n3. Patients with uterine myoma, severe adenomyosis, endometriosis, congenital uterine malformation, endometrial tuberculosis, intrauterine adhesions and other diseases that significantly affect embryo implantation;\n4. Participating in other clinical studies.'}, 'identificationModule': {'nctId': 'NCT05545592', 'briefTitle': 'Reduced Oestrogen Dosage to Improve the Outcome of Frozen-thawed Embryo Transfer', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing University'}, 'officialTitle': 'A Randomized Controlled Trial on Reducing Oestrogen Dosage to Improve the Clinical Outcome of Frozen-thawed Embryo Transfer', 'orgStudyIdInfo': {'id': 'SZ-HRT-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low oestrogen', 'description': 'The patients take orally estradiol tablets 2 mg (Femoston) q.d. during the HRT-FET cycles', 'interventionNames': ['Other: Low oestrogen dosage']}, {'type': 'NO_INTERVENTION', 'label': 'Regular oestrogen', 'description': 'The patients take orally estradiol tablets 2 mg (Femoston) t.i.d. during the HRT-FET cycles'}], 'interventions': [{'name': 'Low oestrogen dosage', 'type': 'OTHER', 'description': 'From the second day of the menstrual cycle, femoston (estradiol tablets) were orally taken 2 mg q.d.. The endometrial thickness and serum oestrogen and progesterone levels were monitored on the 12th to 14th days of the menstrual cycle.', 'armGroupLabels': ['Low oestrogen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210008', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Xing', 'role': 'CONTACT', 'email': 'xing.jun@msn.com', 'phone': '+86 25 8310 7188'}], 'facility': 'Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Jun Xing', 'role': 'CONTACT', 'email': 'xing.jun@msn.com', 'phone': '+862583107188'}, {'name': 'Chenyang Huang', 'role': 'CONTACT', 'email': 'dianshui19901562@126.com', 'phone': '+862583107188'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Li-jun Ding', 'investigatorAffiliation': 'Nanjing University'}}}}