Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-05 @ 5:27 PM
Study NCT ID:
NCT02420704
Status:
UNKNOWN
Last Update Posted:
2015-04-21
First Post:
2015-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Endometrial Thickness on IVF Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004624', 'term': 'Embryo Transfer'}], 'ancestors': [{'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-18', 'studyFirstSubmitDate': '2015-04-15', 'studyFirstSubmitQcDate': '2015-04-17', 'lastUpdatePostDateStruct': {'date': '2015-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ongoing pregnancy rate', 'timeFrame': '12 weeks after embryo transfer', 'description': 'An ongoing pregnancy was defined as a pregnancy with a positive heartbeat by ultrasound after 12 weeks gestation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IVF', 'endometrial thickness', 'cleavage stage embryo', 'blastocyst stage embryo', 'Ongoing pregnancy rate'], 'conditions': ['Infertility']}, 'referencesModule': {'references': [{'pmid': '25296555', 'type': 'BACKGROUND', 'citation': 'Wu Y, Gao X, Lu X, Xi J, Jiang S, Sun Y, Xi X. Endometrial thickness affects the outcome of in vitro fertilization and embryo transfer in normal responders after GnRH antagonist administration. Reprod Biol Endocrinol. 2014 Oct 9;12:96. doi: 10.1186/1477-7827-12-96.'}, {'pmid': '25070912', 'type': 'BACKGROUND', 'citation': 'Zhao J, Zhang Q, Wang Y, Li Y. Endometrial pattern, thickness and growth in predicting pregnancy outcome following 3319 IVF cycle. Reprod Biomed Online. 2014 Sep;29(3):291-8. doi: 10.1016/j.rbmo.2014.05.011. Epub 2014 Jun 13.'}, {'pmid': '24664156', 'type': 'BACKGROUND', 'citation': 'Kasius A, Smit JG, Torrance HL, Eijkemans MJ, Mol BW, Opmeer BC, Broekmans FJ. Endometrial thickness and pregnancy rates after IVF: a systematic review and meta-analysis. Hum Reprod Update. 2014 Jul-Aug;20(4):530-41. doi: 10.1093/humupd/dmu011. Epub 2014 Mar 23.'}]}, 'descriptionModule': {'briefSummary': 'Although many studies have evaluated the relationship between endometrial thickness and IVF outcome, the results are still controversial. We notice that, during our daily work, for patients undergoing cleavage stage embryo transfer, endometrial thickness seems to have a huge impact on IVF outcome; however, for blastocyst stage embryo transfers, IVF outcome seems to have little association with endometrial thickness. Thus, the aim of this prospective observational study is to explore the relationship between endometrial thickness and IVF outcome in patients undergoing cleavage stage and blastocyst stage embryo transfers, respectively.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '22 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients transfrred with at least two high quality cleavage stage embryos, or with at least one high quality blastocyst stage embryo.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 22-38 years old;\n* the first cycle of IVF treatment with standard long protocol;\n* transfrred with at least two high quality cleavage stage embryos, or with at least one high quality blastocyst stage embryo.\n\nExclusion Criteria:\n\n* PGD cycles;\n* gamete donation cycles'}, 'identificationModule': {'nctId': 'NCT02420704', 'briefTitle': 'Effect of Endometrial Thickness on IVF Outcome', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Zhengzhou University'}, 'officialTitle': 'Effect of Endometrial Thickness on IVF Outcome: a Prospective Observational Study of Both Cleavage Stage and Blastocyst Stage Embryo Transfer Cycles', 'orgStudyIdInfo': {'id': 'RMCZZU-Endometrial thickness'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cleavage stage-thin endometrial', 'description': 'Patients transferred with cleavage stage embryo, with endometrial thickness ≤7mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles.', 'interventionNames': ['Procedure: Embryo transfer']}, {'label': 'Cleavage stage-medium endometrial', 'description': 'Patients transferred with cleavage stage embryo, with endometrial thickness 8-13mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles.', 'interventionNames': ['Procedure: Embryo transfer']}, {'label': 'Cleavage stage-thick endometrial', 'description': 'Patients transferred with cleavage stage embryo, with endometrial thickness ≥14mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles.', 'interventionNames': ['Procedure: Embryo transfer']}, {'label': 'Blastocyst stage-thin endometrial', 'description': 'Patients transferred with blastocyst stage embryo, with endometrial thickness ≤7mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles.', 'interventionNames': ['Procedure: Embryo transfer']}, {'label': 'Blastocyst stage-medium endometrial', 'description': 'Patients transferred with blastocyst stage embryo, with endometrial thickness 8-13mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles.', 'interventionNames': ['Procedure: Embryo transfer']}, {'label': 'Blastocyst stage-thick endometrial', 'description': 'Patients transferred with blastocyst stage embryo, with endometrial thickness ≥14mm on the day of HCG (human chorionic gonadotropin) administration for fresh cycles, or on the day starting to use progesterone for frozen thawed cycles.', 'interventionNames': ['Procedure: Embryo transfer']}], 'interventions': [{'name': 'Embryo transfer', 'type': 'PROCEDURE', 'description': 'For fresh cycles, embryos were transferred 3-5 days after oocyte retrieval; For frozen thawed cycles, embryos were transferred 3-5 days after starting to use progesterone based on the stage of cryopreservation.', 'armGroupLabels': ['Blastocyst stage-medium endometrial', 'Blastocyst stage-thick endometrial', 'Blastocyst stage-thin endometrial', 'Cleavage stage-medium endometrial', 'Cleavage stage-thick endometrial', 'Cleavage stage-thin endometrial']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450052', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yingpu Ms Sun, M.D,PhD', 'role': 'CONTACT', 'email': 'syp2008@vip.sina.com', 'phone': '86-13803841888'}, {'name': 'Zhiqin Mr Bu, MD', 'role': 'CONTACT', 'email': 'rmczzu@126.com', 'phone': '86-15981978863'}], 'facility': 'Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Zhiqin Bu, M.D', 'role': 'CONTACT', 'email': 'rmczzu@126.com', 'phone': '86-15981978863'}, {'name': 'Yingpu Sun, M.D', 'role': 'CONTACT', 'email': 'syp2008@vip.sina.com', 'phone': '86-13503841888'}], 'overallOfficials': [{'name': 'Yingpu Sun, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reproductive Medical Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Reproductive Medical Center', 'investigatorFullName': 'Yingpu Sun', 'investigatorAffiliation': 'The First Affiliated Hospital of Zhengzhou University'}}}}