Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2025-12-30 @ 8:35 PM
Study NCT ID:
NCT05969795
Status:
RECRUITING
Last Update Posted:
2025-01-09
First Post:
2023-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011374', 'term': 'Progesterone'}, {'id': 'D004624', 'term': 'Embryo Transfer'}], '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'}, {'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}, {'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 342}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-08', 'studyFirstSubmitDate': '2023-07-24', 'studyFirstSubmitQcDate': '2023-07-24', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Implantation rate', 'timeFrame': '2 months', 'description': 'Number of embryos which have produced ultrasonographic evidence of an intrauterine gestational sac per the total number of embryos transferred into the uterine cavity (Zegers-Hochschild et al., 2009).'}, {'measure': 'Clinical pregnancy rate', 'timeFrame': '2 months', 'description': 'hCG \\> 15 Iu/ml and ultrasound confirmation of a gestational sac'}, {'measure': 'Live birth rate', 'timeFrame': '41 weeks', 'description': 'Number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers (Zegers-Hochschild et al., 2009)'}, {'measure': 'Serum P4 levels on ET day', 'timeFrame': '1 day', 'description': 'Progesterone level on the day of embryo transfer'}, {'measure': 'Serum E2 and P4 levels on day 5 or 6 after ET procedure', 'timeFrame': '6 days', 'description': 'Estradiol and Progesterone levels on day 5 or 6 after embryo transfer'}, {'measure': 'Serum E2 and P4 levels on day 10 after ET procedure', 'timeFrame': '10 days', 'description': 'Estradiol and Progesterone levels on day 10 after embryo transfer'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['implantation rate', 'infertility', 'pregnancy rate', 'natural cycle', 'luteal phase support', 'live birth', 'progesterone'], 'conditions': ['Pregnancy Related', 'Infertility, Female']}, 'referencesModule': {'references': [{'pmid': '36171152', 'type': 'BACKGROUND', 'citation': 'Bortoletto P, Prabhu M, Baker VL. Association between programmed frozen embryo transfer and hypertensive disorders of pregnancy. Fertil Steril. 2022 Nov;118(5):839-848. doi: 10.1016/j.fertnstert.2022.07.025. Epub 2022 Sep 25.'}, {'pmid': '341008', 'type': 'BACKGROUND', 'citation': 'Csapo AI, Pulkkinen M. Indispensability of the human corpus luteum in the maintenance of early pregnancy. Luteectomy evidence. Obstet Gynecol Surv. 1978 Feb;33(2):69-81. doi: 10.1097/00006254-197802000-00001. No abstract available.'}, {'pmid': '6427277', 'type': 'BACKGROUND', 'citation': 'Filicori M, Butler JP, Crowley WF Jr. Neuroendocrine regulation of the corpus luteum in the human. Evidence for pulsatile progesterone secretion. J Clin Invest. 1984 Jun;73(6):1638-47. doi: 10.1172/JCI111370.'}, {'pmid': '30910545', 'type': 'BACKGROUND', 'citation': 'Ginstrom Ernstad E, Wennerholm UB, Khatibi A, Petzold M, Bergh C. Neonatal and maternal outcome after frozen embryo transfer: Increased risks in programmed cycles. Am J Obstet Gynecol. 2019 Aug;221(2):126.e1-126.e18. doi: 10.1016/j.ajog.2019.03.010. Epub 2019 Mar 22.'}, {'pmid': '36308939', 'type': 'BACKGROUND', 'citation': 'Pape J, Levy J, von Wolff M. Early pregnancy complications after frozen-thawed embryo transfer in different cycle regimens: A retrospective cohort study. Eur J Obstet Gynecol Reprod Biol. 2022 Dec;279:102-106. doi: 10.1016/j.ejogrb.2022.10.015. Epub 2022 Oct 21.'}, {'pmid': '36273850', 'type': 'BACKGROUND', 'citation': 'Roelens C, Blockeel C. Impact of different endometrial preparation protocols before frozen embryo transfer on pregnancy outcomes: a review. Fertil Steril. 2022 Nov;118(5):820-827. doi: 10.1016/j.fertnstert.2022.09.003.'}, {'pmid': '3357651', 'type': 'BACKGROUND', 'citation': 'Soules MR, Clifton DK, Steiner RA, Cohen NL, Bremner WJ. The corpus luteum: determinants of progesterone secretion in the normal menstrual cycle. Obstet Gynecol. 1988 May;71(5):659-66.'}, {'pmid': '34730071', 'type': 'BACKGROUND', 'citation': 'Su S, Zeng M, Duan J. Luteal phase support for natural cycle frozen embryo transfer: a meta-analysis. Gynecol Endocrinol. 2022 Feb;38(2):116-123. doi: 10.1080/09513590.2021.1998438. Epub 2021 Nov 3.'}, {'pmid': '22819186', 'type': 'BACKGROUND', 'citation': 'Practice Committee of the American Society for Reproductive Medicine. The clinical relevance of luteal phase deficiency: a committee opinion. Fertil Steril. 2012 Nov;98(5):1112-7. doi: 10.1016/j.fertnstert.2012.06.050. Epub 2012 Jul 20.'}, {'pmid': '30636552', 'type': 'BACKGROUND', 'citation': 'von Versen-Hoynck F, Schaub AM, Chi YY, Chiu KH, Liu J, Lingis M, Stan Williams R, Rhoton-Vlasak A, Nichols WW, Fleischmann RR, Zhang W, Winn VD, Segal MS, Conrad KP, Baker VL. Increased Preeclampsia Risk and Reduced Aortic Compliance With In Vitro Fertilization Cycles in the Absence of a Corpus Luteum. Hypertension. 2019 Mar;73(3):640-649. doi: 10.1161/HYPERTENSIONAHA.118.12043.'}], 'seeAlsoLinks': [{'url': 'http://link.springer.com/10.1007/978-3-319-43011-9_63', 'label': 'Shapiro BS, Garner FC, Aguirre M. The Freeze-All Cycle: A New Paradigm Shift in ART. In Nagy ZP, Varghese AC, Agarwal A, editors. In Vitro Fertilization \\[Internet\\] 2019;, p. 765-778. Springer International Publishing'}]}, 'descriptionModule': {'briefSummary': 'To evaluate whether single euploid embryo transfer in NC without routinely administered LPS is non-inferior to NC with routinely administered LPS.', 'detailedDescription': 'In case the study will show that the live birth rate in single euploid NC frozen embryo transfer cycles without LPS is not inferior to NC cycles with LPS, treatment can be simplified, and participants comfort can be increased.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18 to 40 years\n* Regular ovulatory cycles\n* Availability of at least one euploid embryo after Trophectoderm biopsy for PGT-A on day 5 or day 6\n* Detection of ovulation by P4 rise \\> 1.0 ng/ml after LH surge\n* P4 value of at least 5 ng/ml on day 4 after ovulation\n\nExclusion Criteria:\n\n* History of repeated pre-menstrual spotting\n* Factors affecting the implantation through anatomical changes of the uterus / ovaries or the tubes (adenomyosis, Asherman syndrome, endometriosis, uterine fibroids / polyps, isthmocele with intracavitary fluid presence, hydrosalpinx….)'}, 'identificationModule': {'nctId': 'NCT05969795', 'briefTitle': 'Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support', 'organization': {'class': 'OTHER', 'fullName': 'ART Fertility Clinics LLC'}, 'officialTitle': 'Comparison of Live Birth Rate (> 24 Weeks) in Natural Cycle (NC) Single Euploid Frozen Embryo Transfers (FET) With Versus Without Luteal Phase Support (LPS)', 'orgStudyIdInfo': {'id': '2306-ABU-009-BL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Study Group', 'description': 'Intermittent ultrasound scans to monitor follicular growth and serial measurements of serum LH, E2 and P4 levels throughout the cycle to determine ovulation. Embryo transfer (ET) will be scheduled on the fifth day after ovulation. Blood for P4 measurement will be drawn upon admission to the clinic for the ET procedure. P4 will be measured on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure.', 'interventionNames': ['Diagnostic Test: Transvaginal ultrasound', 'Diagnostic Test: Serial serum LH, E2, P4', 'Diagnostic Test: Serum P4 day of ET - Study Group', 'Procedure: Embryo transfer', 'Diagnostic Test: Serum hCG 10 days after ET', 'Diagnostic Test: Serum P4 10 days after ET']}, {'type': 'OTHER', 'label': 'Control Group', 'description': 'Intermittent ultrasound scans to monitor follicular growth and serial measurements of serum LH, E2 and P4 levels throughout the cycle to determine ovulation. Embryo transfer (ET) will be scheduled on the fifth day after ovulation. Administer on FET day 200 mg of P4 and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. Blood for P4 measurement will be drawn before starting LPS in form of vaginal progesterone. P4 will be measured on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy.', 'interventionNames': ['Diagnostic Test: Transvaginal ultrasound', 'Diagnostic Test: Serial serum LH, E2, P4', 'Drug: Progesterone 100 Mg Vaginal Insert', 'Diagnostic Test: Serum P4 day of ET - Control Group', 'Procedure: Embryo transfer', 'Diagnostic Test: Serum hCG 10 days after ET', 'Diagnostic Test: Serum P4 10 days after ET']}], 'interventions': [{'name': 'Transvaginal ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Intermittent transvaginal ultrasound throughout the cycle to monitor follicular growth', 'armGroupLabels': ['Control Group', 'Study Group']}, {'name': 'Serial serum LH, E2, P4', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serial measurements of serum Luteinizing Hormone (LH), Estradiol (E2) and Progesterone (P4 )levels throughout the cycle to determine ovulation. LH-surge is identified when a rise of 180% above the previous level occurred and ovulation is confirmed with a decrease in E2 concentration, and a rise of progesterone level to ≥ 1.0 ng/ml (Irani et al., 2017).', 'armGroupLabels': ['Control Group', 'Study Group']}, {'name': 'Progesterone 100 Mg Vaginal Insert', 'type': 'DRUG', 'otherNames': ['Progesterone 100Mg Vag Tab'], 'description': 'On day of ET procedure, to administer 200 mg of vaginal progesterone and increase to 300 mg/day from the day after the ET onwards until the pregnancy test. In case of an implantation, vaginal P4 will be continued until 7 weeks of pregnancy', 'armGroupLabels': ['Control Group']}, {'name': 'Serum P4 day of ET - Control Group', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum P4 will be drawn before starting LPS in form of vaginal progesterone on the day of ET procedure', 'armGroupLabels': ['Control Group']}, {'name': 'Serum P4 day of ET - Study Group', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum P4 will be drawn when study group participants are admitted to the clinic for the ET procedure.', 'armGroupLabels': ['Study Group']}, {'name': 'Embryo transfer', 'type': 'PROCEDURE', 'otherNames': ['ET'], 'description': 'The procedure in which embryo is placed in the uterus.', 'armGroupLabels': ['Control Group', 'Study Group']}, {'name': 'Serum hCG 10 days after ET', 'type': 'DIAGNOSTIC_TEST', 'description': 'Pregnancy will be confirmed / excluded by measurement of serum hCG 10 days after ET procedure and a level of \\> 15 IU will be regarded as positive result. The definitions of biochemical, ectopic, clinical and ongoing pregnancy follow the ICMART criteria (Zegers-Hochschild, 2006)', 'armGroupLabels': ['Control Group', 'Study Group']}, {'name': 'Serum P4 10 days after ET', 'type': 'DIAGNOSTIC_TEST', 'description': 'Serum P4 will be drawn on day 5 or day 6 after the ET procedure and together with the hCG 10 days after ET procedure', 'armGroupLabels': ['Control Group', 'Study Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60202', 'city': 'Abu Dhabi', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Barbara Lawrenz, PhD', 'role': 'CONTACT', 'email': 'barbara.lawrenz@artfertilityclinics.com', 'phone': '+971 800 337845489'}], 'facility': 'ART Fertility Clinics LLC', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}, {'city': 'Al Ain City', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Anastasia Salame', 'role': 'CONTACT', 'email': 'jonalyn.edades@artfertilityclinics.com', 'phone': '+971 800 337845489'}], 'facility': 'ART Fertility Clinics Al Ain', 'geoPoint': {'lat': 24.19167, 'lon': 55.76056}}, {'city': 'Dubai', 'status': 'NOT_YET_RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Carol Coughlan, PhD', 'role': 'CONTACT', 'email': 'jonalyn.edades@artfertilityclinics.com', 'phone': '+971 800 337845489'}], 'facility': 'ART Fertility Clinics Dubai', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}], 'centralContacts': [{'name': 'Barbara Lawrenz, PhD', 'role': 'CONTACT', 'email': 'barbara.lawrenz@artfertilityclinics.com', 'phone': '+971 800 337845489'}, {'name': 'Jonalyn Edades, RN', 'role': 'CONTACT', 'email': 'jonalyn.edades@artfertilityclinics.com', 'phone': '+971 800 337845489'}], 'overallOfficials': [{'name': 'Barbara Lawrenz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ART Fertility Clinics LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ART Fertility Clinics LLC', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Scientific Director', 'investigatorFullName': 'Barbara Lawrenz', 'investigatorAffiliation': 'ART Fertility Clinics LLC'}}}}