Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2025-12-25 @ 8:10 PM
Study NCT ID:
NCT05588635
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2022-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association Between Live Birth Rate and Serum Progesterone During Hormonal Replacement Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016471', 'term': 'Ovarian Hyperstimulation Syndrome'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-10-17', 'lastUpdatePostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of factors on the embryo transfer day that predict live birth after frozen-thawed embryo transfer', 'timeFrame': 'On the day of embryo transfer (Day 0)', 'description': 'The following variables were compared between groups: mother age (years), father age (years), serum progesterone (ng/ml), mother body mass index (kg/m2), serum Antimüllerian hormone (AMH) (ng/ml), infertility etiology (yes/no): 4 categories: idiopathic etiology, mixed origin infertility, male infertility, female infertility; smoker status among mothers (yes/no).'}], 'secondaryOutcomes': [{'measure': 'Pregnancy status', 'timeFrame': '12 days after embryo transfer (Day 12)', 'description': 'Pregnancy status (yes/no)'}, {'measure': 'Serum progesterone', 'timeFrame': '12 days after embryo transfer (Day 12)', 'description': 'Measurement of serum progesterone (ng/ml)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['serum progesterone', 'frozen-thawed embryo transfer', 'live birth rate'], 'conditions': ['Ovarian Hyperstimulation Syndrome', 'Frozen-thawed Embryo Transfers']}, 'descriptionModule': {'briefSummary': 'Nowadays, frozen-thawed embryo transfers (FET) are expending. This practice avoids risk of ovarian hyperstimulation syndrome (OHSS), as well as allowing better synchronization between endometrium and embryo, which is fundamental for pregnancy.\n\nThere are several FET protocols, including hormonal replacement therapy cycle (HRT), which enable clinicians to adapt the day of embryo transfer.\n\nHowever, increase in spontaneous miscarriages was observed with this latter protocol compared to fresh embryo transfers and the other endometrial preparations (natural and stimulated), in relation with the lack of physiological corpus luteum.\n\nThen, Clinicians interrogate about measuring serum progesterone in order to adjust their treatment and/or transfer date. Various studies have shown thresholds below and/or above which pregnancy or live birth rate were lowered.\n\nThe main objective is to find a serum progesterone threshold on the day of embryo transfer above which live birth rate is increased. The secondary objectives are to analyze the factors associated with increased serum progesterone on the day of transfer, to analyze the miscarriage rate, and impact of change on luteal phase support on day 12.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '43 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient having frozen-thawed single embryo transfer of a day-5 blastocyst with hormonal replacement therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women between 18 and 43,\n* having frozen-thawed single embryo transfer of a day-5 blastocyst with hormonal replacement therapy, with measurement of serum progesterone on the day of transfer\n\nExclusion Criteria:\n\n* frozen-thawed transfer of a day-2 or -3 or -6 embryo,\n* double embryo transfer,\n* other protocol than HRT,\n* patient without serum progesterone measurement on the day of transfer'}, 'identificationModule': {'nctId': 'NCT05588635', 'acronym': 'PROGEVOL', 'briefTitle': 'Association Between Live Birth Rate and Serum Progesterone During Hormonal Replacement Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Régional Metz-Thionville'}, 'officialTitle': 'Association Between Live Birth Rate and Serum Progesterone on Frozen-thawed Embryo Transfer Day: Retrospective Study', 'orgStudyIdInfo': {'id': '2022-05Obs-CHRMT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'With live birth group', 'description': 'patients with live birth following frozen-thawed embryo transfer', 'interventionNames': ['Other: Identification of predictive factors']}, {'label': 'Without live birth group', 'description': 'patients without live birth following frozen-thawed embryo transfer', 'interventionNames': ['Other: Identification of predictive factors']}], 'interventions': [{'name': 'Identification of predictive factors', 'type': 'OTHER', 'description': 'Evaluation of the following variables : mother age (years), father age (years), serum progesterone (ng/ml), mother body mass index (kg/m2), serum Antimüllerian hormone (AMH) (ng/ml), infertility etiology (yes/no): 4 categories: idiopathic etiology, mixed origin infertility, male infertility, female infertility; smoker status among mothers (yes/no).', 'armGroupLabels': ['With live birth group', 'Without live birth group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57085', 'city': 'Metz', 'country': 'France', 'facility': 'CHR Metz-Thionville/Hopital de Mercy', 'geoPoint': {'lat': 49.11911, 'lon': 6.17269}}], 'overallOfficials': [{'name': 'Ariane GOUTALAND, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHR Metz Thionville Hopital de Mercy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Régional Metz-Thionville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}