Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2026-01-02 @ 9:07 AM
Study NCT ID:
NCT04733235
Status:
COMPLETED
Last Update Posted:
2023-01-03
First Post:
2021-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
the Effect of Endometrial Compaction Caused by Progesterone Effect on Pregnancy Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011374', 'term': 'Progesterone'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-29', 'studyFirstSubmitDate': '2021-01-17', 'studyFirstSubmitQcDate': '2021-01-27', 'lastUpdatePostDateStruct': {'date': '2023-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in endometrial thickness', 'timeFrame': '1 year', 'description': 'changing in millimeters of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.'}, {'measure': 'ongoing pregnancy rates.', 'timeFrame': '1 year', 'description': 'pregnancy beyond 12 weeks of gestational age.'}], 'secondaryOutcomes': [{'measure': 'The Correlation of Serum Progesterone Levels With the Degree of Endometrial Compaction on the Day of Frozen Embryo Transfer', 'timeFrame': 'On the day of frozen embryo transfer', 'description': 'comparison of progesterone levels and endometrial thickness'}, {'measure': 'Clinical pregnancy rate', 'timeFrame': '6-7 weeks after the last menstrual period of the patient', 'description': '6th week gestational age'}, {'measure': 'Implantation rate', 'timeFrame': '5 weeks after the last menstrual period of the patient', 'description': 'Percentage of gestational sacs compared to the number of embryos transferred'}, {'measure': 'Clinical miscarriage', 'timeFrame': 'after 5th gestational week', 'description': 'pregnancy loss after ultrasonographic detection of an intrauterine gestational sac'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infertility', 'female infertility', 'frozen- thawed embryo transfer', 'female'], 'conditions': ['Infertility', 'Female Infertility', 'Frozen-thawed Embryo Transfer']}, 'referencesModule': {'references': [{'pmid': '31248618', 'type': 'RESULT', 'citation': 'Haas J, Smith R, Zilberberg E, Nayot D, Meriano J, Barzilay E, Casper RF. Endometrial compaction (decreased thickness) in response to progesterone results in optimal pregnancy outcome in frozen-thawed embryo transfers. Fertil Steril. 2019 Sep;112(3):503-509.e1. doi: 10.1016/j.fertnstert.2019.05.001. Epub 2019 Jun 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes', 'detailedDescription': 'For a pregnancy to occur, the embryo must implant in a receptive endometrium during the window of implantation, which is thought to occur from day 22 to 24 of an idealized 28-day cycle. Early studies have suggested that assessing endometrial thickness with the use of ultrasound may be an alternative to invasive techniques such as endometrial biopsy for attempting to determine a receptive endometrium for frozen-thawed embryo transfer (FET).\n\nA preovulatory endometrial thickness of 7 mm or more is considered to be the cutoff for endometrial receptivity, below which many physicians would cancel an embryo transfer. However, in most studies in the literature, endometrial thickness was measured either on the day of hCG in fresh embryo transfer cases or on the last day of estrogen treatment in thawed embryo transfers. There are a limited number of studies evaluating the luteal period, embryo transfer day and endometrial thickness.\n\nAccordingly, in this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women underwent frozen embryo transfer', 'genderDescription': 'Female patients underwent infertility treatment', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Woman aged 18-40 years\n2. Presence of high quality (\\>2BB) blastocyst\n3. Hormonal(estrogen and progesterone) frozen- thawed embryo transfer cycles\n4. presence of high quality blastocyst cryopreserved by vitrification method.\n5. A single embryo transfer\n\nExclusion Criteria:\n\n1. Presence of uterine pathology\n2. Participants whose optimal endometrial image cannot be obtained due to uterine position\n3. Participants whose treatments were canceled for any reason before embryo transfer\n4. Participants which had embryo transfer on the day 2 or 3 (at the cleavage stage)\n5. Participants who had 2 embryo transfer\n6. Presence of low quality (\\<2BB) blastocyst\n7. \\> 15% loss of viability in the embryo during embryo thawing'}, 'identificationModule': {'nctId': 'NCT04733235', 'briefTitle': 'the Effect of Endometrial Compaction Caused by Progesterone Effect on Pregnancy Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'The Effect of Progesterone Induced Endometrial Compaction on Pregnancy Outcomes in Frozen-thawed Embryo Transfer at the Blastocyst Stage', 'orgStudyIdInfo': {'id': 'AkdenizUKD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'with endometrial compaction', 'description': 'Participants who have endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement', 'interventionNames': ['Drug: Progesterone']}, {'label': 'without endometrial compaction', 'description': 'Participants who have not endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement', 'interventionNames': ['Drug: Progesterone']}], 'interventions': [{'name': 'Progesterone', 'type': 'DRUG', 'otherNames': ['Diagnostic Test: Blood test Measurement of E2, P4, LH, FSH hormones Diagnostic Test: Transvaginal'], 'description': 'ultrasound measurements of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.', 'armGroupLabels': ['with endometrial compaction', 'without endometrial compaction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Akdeniz University', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'ASSOCIATE PROFESSOR', 'investigatorFullName': 'ŞAFAK OLGAN', 'investigatorAffiliation': 'Akdeniz University'}}}}