Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-01-06 @ 1:07 AM
Study NCT ID:
NCT02148393
Status:
COMPLETED
Last Update Posted:
2018-03-09
First Post:
2014-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implantation Enhancement by Elective Cryopreservation of All Viable Embryos
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': 'D058989', 'term': 'Vitrification'}, {'id': 'D036801', 'term': 'Parturition'}, {'id': 'D006063', 'term': 'Chorionic Gonadotropin'}, {'id': 'C000624167', 'term': 'Utrogestan'}, {'id': 'D004958', 'term': 'Estradiol'}], 'ancestors': [{'id': 'D044367', 'term': 'Phase Transition'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011247', 'term': 'Pregnancy'}, {'id': 'D012098', 'term': 'Reproduction'}, {'id': 'D055703', 'term': 'Reproductive Physiological Phenomena'}, {'id': 'D012101', 'term': 'Reproductive and Urinary Physiological Phenomena'}, {'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010926', 'term': 'Placental Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011257', 'term': 'Pregnancy Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 212}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-08', 'studyFirstSubmitDate': '2014-05-16', 'studyFirstSubmitQcDate': '2014-05-27', 'lastUpdatePostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rates', 'timeFrame': '7 weeks', 'description': 'Pregnancy visible under transvaginal pelvic ultrasound'}], 'secondaryOutcomes': [{'measure': 'Ovarian hyperstimulation syndrome incidence', 'timeFrame': '8 weeks', 'description': 'Observation of early-onset ovarian hyperstimulation syndrome'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infertility', 'OHSS']}, 'referencesModule': {'references': [{'pmid': '33539543', 'type': 'DERIVED', 'citation': 'Zaat T, Zagers M, Mol F, Goddijn M, van Wely M, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011184. doi: 10.1002/14651858.CD011184.pub3.'}, {'pmid': '32964939', 'type': 'DERIVED', 'citation': 'Santos-Ribeiro S, Mackens S, Popovic-Todorovic B, Racca A, Polyzos NP, Van Landuyt L, Drakopoulos P, de Vos M, Tournaye H, Blockeel C. The freeze-all strategy versus agonist triggering with low-dose hCG for luteal phase support in IVF/ICSI for high responders: a randomized controlled trial. Hum Reprod. 2020 Dec 1;35(12):2808-2818. doi: 10.1093/humrep/deaa226.'}]}, 'descriptionModule': {'briefSummary': 'A randomised controlled open-label clinical trial to compare the clinical pregnancy rates between fresh embryo transfer and elective all-embryo vitrification with thawing and transfer in a subsequent cycle in high-responders', 'detailedDescription': 'Two-arm randomised, single-centre, controlled open-label trial. Summarily, women undergoing exogenous gonadotropin ovarian stimulation for ART in a gonadotropin-releasing hormone (GnRH) antagonist down-regulated cycle and at high risk for ovarian hyperstimulation syndrome (OHSS) will be included in either the control ("fresh embryo transfer") or intervention ("subsequent vitrified-warmed embryo transfer") groups. Women in the control group will undergo GnRH agonist triggering followed by intensified luteal phase support while the intervention group will electively vitrify all viable embryos after GnRH triggering and perform the embryo transfer (ET) in a subsequent unstimulated cycle.\n\nOvarian stimulation, ultrasound and hormonal monitoring, ovulation induction, oocyte retrieval, embryology procedure, IVF and luteal support will be according to how they are normally performed in our centre.\n\nAll women included will undergo artificial ovarian stimulation with GnRH antagonist down-regulation with daily injections of either ganirelix (Orgalutran®) or cetrorelix (Cetrotide®). Treating physicians will opt on which exogenous gonadotropins should be used according to the patient\'s profile and preference and can include either recombinant follicle stimulating hormone (FSH) or highly purified urinary human menopausal gonadotropin (HP-HMG). Ovarian stimulation will commence after it is confirmed that the patient is not pregnant and has basal levels of oestradiol, progesterone, FSH and luteinising hormone (LH). The stimulation will be monitored simultaneously by pelvic ultrasound and hormonal analyses (oestradiol, progesterone), starting on day 7 of stimulation and then every 1 to 3 days, according to the individual endocrine profile and follicular development.\n\nFinal oocyte maturation will be triggered with 0.2 mg triptorelin (Decapeptyl®, Gonapeptyl®) as soon as 3 follicles of ≥17 mm are observed. A GnRH agonist will be the preferred triggering agent for both groups to reduce the risk of severe OHSS associated with human chorionic gonadotropin (hCG) triggering in high-responders. Oocyte retrieval will be performed 36 hours after hCG administration under either local anaesthesia with analgesic premedication or general anaesthesia, according to patient preference.\n\nIVF/ICSI will be performed, using the specimen of sperm made available by the male progenitor on the day of oocyte retrieval.\n\nThe choice to transfer one or two embryos will be decided by the clinician at consultation mainly depending on the patient\'s age and the number of embryos replaced in the previous treatment cycles, according to Belgian law.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* First or second IVF/ICSI cycle\n* High response to ovarian stimulation (defined as presence of ≥18 follicles of ≥11 mm on the day of GnRH triggering)\n* GnRH antagonist down-regulation\n* Signed informed consent\n* Patients can be included only once in the trial\n* Planned replacement of 1 or 2 blastocysts\n\nExclusion Criteria:\n\n* Other known reasons for impaired implantation (i.e. hydrosalpinx, fibroid distorting the endometrial cavity, Asherman's syndrome, thrombophilia or endometrial tuberculosis)\n* Oocyte/embryos donation acceptors\n* Embryos planned to undergo preimplantation genetic diagnosis/screening\n* Body mass index ≥35 or ≤18\n* Women who have previously enrolled in the trial\n* Those unable to comprehend the investigational nature of the proposed study"}, 'identificationModule': {'nctId': 'NCT02148393', 'acronym': 'ICE', 'briefTitle': 'Implantation Enhancement by Elective Cryopreservation of All Viable Embryos', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Elective Blastocyst Vitrification for Endometrial Receptivity Enhancement in High-responder Patients Undergoing in Vitro Fertilisation/Intracytoplasmatic Sperm Injection (IVF/ICSI)', 'orgStudyIdInfo': {'id': '2014-128'}, 'secondaryIdInfos': [{'id': '2014-001480-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'In the control group, following oocyte retrieval, intensified luteal phase support for fresh embryo transfer (with Pregnyl®, Utrogestan® and Progynova®) will be performed. Fresh ET in the uterine cavity will be performed on the 5th day of embryo development at blastocyst stage under ultrasound guidance whenever possible.', 'interventionNames': ['Procedure: Intensified luteal phase support for fresh embryo transfer', 'Drug: Pregnyl®', 'Drug: Utrogestan®', 'Drug: Progynova®']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Elective vitrification with subsequent-cycle embryo thawing/transfer (CryoBioSystem®) will be performed. Hence, no luteal phase support will be provided immediately after oocyte retrieval. Instead, patients will wait for a subsequent cycle before starting exogenous hormone therapy for endometrial preparation.\n\nOn the day of embryo transfer, blastocyst(s) will be warmed one by one until one or two blastocysts are suitable for transfer. ET to the uterine cavity will be performed under ultrasound guidance whenever possible.', 'interventionNames': ['Procedure: Vitrification with subsequent-cycle embryo thawing/transfer', 'Device: CryoBioSystem®']}], 'interventions': [{'name': 'Vitrification with subsequent-cycle embryo thawing/transfer', 'type': 'PROCEDURE', 'description': 'The vitrification process will be performed under the same conditions of all other vitrification procedures usually performed in our centre. In summary, vitrification will be accomplished using closed high security straws (CryoBioSystem®) in combination with dimethylsulfoxide, ethylene glycol and sucrose as cryoprotectants (Irvine ScientificR Freeze Kit®).\n\nIn the meantime, patients will wait for a subsequent cycle before starting exogenous hormone therapy for endometrial preparation.', 'armGroupLabels': ['Intervention']}, {'name': 'Intensified luteal phase support for fresh embryo transfer', 'type': 'PROCEDURE', 'description': 'A single administration of 1500 IU of exogenous hCG (Pregnyl®) 1 hour after oocyte retrieval followed by daily vaginally-administered progesterone 200 mg tid (Utrogestan®) and oestradiol valerate 2 mg bid (Progynova®).', 'armGroupLabels': ['Control']}, {'name': 'Pregnyl®', 'type': 'DRUG', 'otherNames': ['hCG'], 'description': '1500 IU', 'armGroupLabels': ['Control']}, {'name': 'Utrogestan®', 'type': 'DRUG', 'otherNames': ['Vaginal progesterone'], 'description': '200 mg tid', 'armGroupLabels': ['Control']}, {'name': 'Progynova®', 'type': 'DRUG', 'otherNames': ['Estradiol valerate'], 'description': '2 mg bid', 'armGroupLabels': ['Control']}, {'name': 'CryoBioSystem®', 'type': 'DEVICE', 'description': 'CryoBioSystem® in combination with dimethylsulfoxide, ethylene glycol and sucrose as cryoprotectants (Irvine ScientificR Freeze Kit®) closed in high security straws', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1600-548', 'city': 'Brussels', 'state': 'Lisboa', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Samuel Santos-Ribeiro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}, {'name': 'Christophe Blockeel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Samuel Santos-Ribeiro', 'investigatorAffiliation': 'Universitair Ziekenhuis Brussel'}}}}