Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2026-01-05 @ 1:40 PM
Study NCT ID:
NCT01595334
Status:
UNKNOWN
Last Update Posted:
2012-05-25
First Post:
2012-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Influence of Leutinizing Hormone (LH) on Oocyte Maturity
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': 'C062876', 'term': 'cetrorelix'}, {'id': 'C493311', 'term': 'luprolide acetate gel depot'}, {'id': 'D016729', 'term': 'Leuprolide'}], 'ancestors': [{'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-05-24', 'studyFirstSubmitDate': '2012-04-27', 'studyFirstSubmitQcDate': '2012-05-08', 'lastUpdatePostDateStruct': {'date': '2012-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of mature oocytes immediately after oocyte recovery', 'timeFrame': 'Women would be followed every 2 weeks upto 6 weeks after embryo transfer', 'description': 'Number of mature oocytes would be measured immediately after the oocyte recovery'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy', 'timeFrame': 'Women would be followed every 2 weeks upto 6 weeks after embryo transfer', 'description': 'Diagnosed by transvaginal ultrasound.Appearance of yolk sac with fetal heart beat at 6 weeks of gestation.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['IVF-ET', 'ICSI', 'Gonadotrophins', 'rFSH', 'rLH', 'Cetrorelix', 'Leuprolide acetate'], 'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': "1. Leutinizing hormone (LH) has been demonstrated to exert variable physiological actions during menstrual cycle at appropriate plasma levels'\n2. In early follicular phase,in the requisite range,LH is known to contribute to maturation of oocyte during transition phase from metaphase-1(M1) to metaphase-2 (M2).\n3. If during this transition, appropriate level of LH can be maintained either through the use of gonadotropin releasing hormone (GnRH) antagonist if found excessive or supplementation with exogenous LH, if found deficient, maturation process can be enhanced.\n4. Further maintenance of suitable combination of recombinant follicle stimulating hormone (rFSH) + rLH can help in realizing higher yield of mature M2 oocytes,with higher probability of establishing clinical pregnancy.", 'detailedDescription': "The study is planned to assess whether maintenance of levels of LH through the use of GnRH antagonist would contribute to obtaining mature M2 oocytes so that maximum number of good quality embryo's with potential to implant is obtained.\n\nThe mature oocytes would be subjected to either standard in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) depending on the status of the male factor.\n\nThe objective would be to obtain good quality embryo's with implantation potential for fresh embryo transfer and/or subsequent frozen thaw embryo transfer.\n\nIn both these events, the secondary outcome measures would be establishment of clinical pregnancy by transvaginal ultrasound performed 6 weeks after embryo transfer."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-40 years\n* Primary or secondary infertility\n* Desire to achieve pregnancy\n* Basal FSH \\<12 mIU/ML\n* Moderate to good ovarian reserve (antimullerian hormone (AMH) \\>1ng/ml, and/ or antral follicle count (AFC)\\>8 between both ovaries)\n* Informed written consent from both partners\n* BMI \\<35 kg/mtr.sq.\n* No genetic abnormality\n\nExclusion Criteria:\n\n* Hormonal preparation taken within 3 month prior to recruitment\n* Women with previous poor response to gonadotrophins\n* History of previous 3 or more miscarriages\n* Women with uncorrected tubal/uterine pathology\n* Women opting for assisted procedures like embryo hatching etc.'}, 'identificationModule': {'nctId': 'NCT01595334', 'acronym': 'LH/M2-Oocyte', 'briefTitle': 'Study on Influence of Leutinizing Hormone (LH) on Oocyte Maturity', 'organization': {'class': 'OTHER', 'fullName': 'Southern Cross Fertility Centre'}, 'officialTitle': 'Is it Possible to Obtain Higher Yield of Mature M2 Oocytes by Establishing Appropriate Levels of LH During Controlled Ovarian Hyperstimulation (COH) in Antagonist Cycles for In-vitro Fertilization-embryo Transfer (IVF-ET)/ Intracytoplasmic Sperm Injection (ICSI)?', 'orgStudyIdInfo': {'id': 'MB/LH-M2/OM/2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study subjects desiring pregnancy', 'description': 'Study subjects to be treated with rFSH, rLH throughout controlled ovarian hyperstimulation (COH) in appropriate dosages,considering age, body mass index (BMI), ovarian reserve, etc. and GnRH antagonist, cetrorelix in 0.25 mg/d when needed till the desired follicular maturity and the minimum required number of follicles are achieved.\n\nINTRVENTIONS - Monitoring at regular intervals by transvaginal ultrasound and hormonal studies.Once pregnancy established by beta-human chorionic gonadotropin (hCG) and ultrasound will be supported by intervention of adequate luteal support by estrogen (E) + progesterone (P) for 12 weeks of gestation.', 'interventionNames': ['Drug: Cetrorelix']}, {'type': 'OTHER', 'label': 'Control subjects desiring pregnancy', 'description': "Control subjects selected in randomized way,desiring pregnancy will be treated with gonadotrophins, rFSH and rLH in appropriate dosages considering age, BMI, ovarian reserve, etc. after standard downregulation with GnRH agonist, Leuprolide acetate, 1 mg/d under established 'Long Luteal Suppression Protocol' from the previous cycle.\n\nINTERVENTIONS - Monitoring of response to treatment by hormonal study and sonography evaluation at regular intervals during COH till adequate number of mature follicles of minimum 18 mm mean diameter is achieved, to be followed by hCG trigger and ovum pick-up (OPU) and embryo transfer (ET). Chemical pregnancy by beta-hCG would be confirmed 14 days post-ET. Clinical pregnancy would be confirmed by sonography 6 weeks after ET (visibility of yolk sac and fetal heart-beat). Pregnancy support by E+P for 12 weeks would be provided.", 'interventionNames': ['Drug: Luprolide Acetate']}], 'interventions': [{'name': 'Cetrorelix', 'type': 'DRUG', 'otherNames': ['Cetrotide'], 'description': 'Cetrorelix 0.25 mg/d would be administered by subcutaneous injection to women when the plasma LH is higher (\\>4.5 mIU/ml) in the study arm', 'armGroupLabels': ['Study subjects desiring pregnancy']}, {'name': 'Luprolide Acetate', 'type': 'DRUG', 'otherNames': ['Lupron'], 'description': 'Women in the control arm would receive Luprolide acetate 1 mg/day by subcutaneous injection', 'armGroupLabels': ['Control subjects desiring pregnancy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anand', 'state': 'Gujarat', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Nayana Patel, MD', 'role': 'CONTACT'}, {'name': 'Nayana Patel;, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sat Kaival Hospital Pvt. Ltd.', 'geoPoint': {'lat': 22.55251, 'lon': 72.9552}}, {'city': 'Indore', 'state': 'Madhya Pradesh', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Asha Baxi, MD, FRCOG', 'role': 'CONTACT'}, {'name': 'Asha Baxi, MD, FRCOG', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Disha Fertility & Surgical Hospital', 'geoPoint': {'lat': 22.71792, 'lon': 75.8333}}, {'city': 'Mumbai', 'state': 'Maharashtra', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Faram Irani, MD', 'role': 'CONTACT'}, {'name': 'Faram Irani, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Southern Cross Fertility Center', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}], 'centralContacts': [{'name': 'Manchi Bharucha, Ph.D.', 'role': 'CONTACT', 'email': 'drmanchi41@gmail.com', 'phone': '91-9892211941'}, {'name': 'Nayna Patel', 'role': 'CONTACT', 'email': 'minipatel2000@yahoo.com', 'phone': '91-02692650090'}], 'overallOfficials': [{'name': 'M R Bharucha, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sat Kaival Pvt. Ltd, Anand, Gujarat'}, {'name': 'Nayana Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sat Kaival Hospital Pvt. Ltd, Anand, Guajarat'}, {'name': 'Faram Irani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern Cross Fertility Center, Mumbai, India'}, {'name': 'Asha Baxi, MD, FRCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Disha Fertility & Surgical Hospital, Indore, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern Cross Fertility Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Disha Fertility and Surgical Centre,Indore,India', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}