Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2025-12-26 @ 1:36 AM
Study NCT ID:
NCT03457233
Status:
UNKNOWN
Last Update Posted:
2018-03-07
First Post:
2018-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Body Weight on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006062', 'term': 'Gonadotropins'}, {'id': 'D008596', 'term': 'Menotropins'}, {'id': 'C092464', 'term': 'LHRH, Ac-Nal(1)-Cpa(2)-Trp(3)-Arg(6)-Ala(10)-'}, {'id': 'C062876', 'term': 'cetrorelix'}], 'ancestors': [{'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D006065', 'term': 'Gonadotropins, Pituitary'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 185}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-06', 'studyFirstSubmitDate': '2018-02-25', 'studyFirstSubmitQcDate': '2018-03-06', 'lastUpdatePostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': '4 weeks after HCG triggering', 'description': 'appearance of intrauterine gestational sac by transvaginal ultrasound'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Invitro Fertilization']}, 'referencesModule': {'references': [{'pmid': '30407618', 'type': 'DERIVED', 'citation': 'Maged AM, Fahmy RM, Rashwan H, Mahmood M, Hassan SM, Nabil H, Hany A, Lotfy R, Lasheen YS, Dahab S, Darwish M. Effect of body mass index on the outcome of IVF cycles among patients with poor ovarian response. Int J Gynaecol Obstet. 2019 Feb;144(2):161-166. doi: 10.1002/ijgo.12706. Epub 2018 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'Induction of ovulation cycle:\n\n1. Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration(choriomon,IBSA10000IU) with starting dose 300 to 450iu.\n2. GNRH antagonist (cetrorelix 0,25mg s.c, cetrotide, serono laboratories, Aubonne Switzerland) is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration\n3. Ovarian ultrasound scans were performed using a 5.0-9.0 MHZ multi frequency trans vaginal probe (mindrayDP-5)to assess the ovarian response till the mature follicles reach18-20mm when hCG administration 10000 IU is given.Serum E2 level is done on day of HCG trigger.\n4. Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection\n5. Progesterone vaginal tablets (Prontogest,IBSA) are administrated 400mg twice daily as luteal support from the day of oocytes retrieval.\n6. Ultrasound -guided fresh embryo transfer is performed on day 2 or 3 after fertilization.\n7. Serum hCG assessment to detect pregnancy is performed at 14 days after embryo transfer .if positive(chemical pregnancy) ,women undergo trans -vaginal ultrasonography 2 weeks after, to confirm fetal pulsations as well as number of gestational sacs (clinical pregnancy).\n8. The implantation rate is calculated as the number of viable embryos divided by the number of transferred embryos multiplied by 100', 'detailedDescription': 'Induction of ovulation cycle:\n\n1. Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration(choriomon,IBSA10000IU) with starting dose 300 to 450iu.\n2. GNRH antagonist (cetrorelix 0,25mg s.c, cetrotide, serono laboratories, Aubonne Switzerland) is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration\n3. Ovarian ultrasound scans were performed using a 5.0-9.0 MHZ multi frequency trans vaginal probe (mindrayDP-5)to assess the ovarian response till the mature follicles reach18-20mm when hCG administration 10000 IU is given.Serum E2 level is done on day of HCG trigger.\n4. Trans vaginal ultrasound-guided oocyte retrieval is performed 34-36 hours after hCG injection\n5. Progesterone vaginal tablets (Prontogest,IBSA) are administrated 400mg twice daily as luteal support from the day of oocytes retrieval.\n6. Ultrasound -guided fresh embryo transfer is performed on day 2 or 3 after fertilization.\n7. Serum hCG assessment to detect pregnancy is performed at 14 days after embryo transfer .if positive(chemical pregnancy) ,women undergo trans -vaginal ultrasonography 2 weeks after, to confirm fetal pulsations as well as number of gestational sacs (clinical pregnancy).\n8. The implantation rate is calculated as the number of viable embryos divided by the number of transferred embryos multiplied by 100'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 4- Poor responder according to ESHRE consensus; in which at least 2 of the following should be present: Advanced maternal age (≥ 40 years old) or any other risk factor A previous poor ovarian response (cycles cancelled or ≤ 3 oocytes with a conventional protocol)An abnormal ovarian reserve test (ORT); antral follicle count (AFC) \\< 5-7 follicles or anti-mullerian hormone (AMH) ≤0.5- 1.1 ng/ml In the absence of advanced maternal age or abnormal ORT, two previous episodes of poor ovarian response after maximal stimulation patients are also considered poor responders according to ESHRE consensus.\n\nPresence and Adequate visualization of both ovaries Uterine cavity within normal anatomy assessed with HSG, hysteroscopy and TVUS\n\nExclusion Criteria:\n\nAny factor which may affect reproductive outcome other than that the patient is a poor responder will be excluded from the study, like:\n\n1. Severe male factor .\n2. Uterine factor (eg: fibroid, polyp, Ashermann, .. etc)\n3. Immunological disorder (eg: SLE, APS, … etc)\n4. Thyroid or adrenal dysfunction\n5. Neoplasia (especially: hypothalamic, pit, ovarian)\n6. Women diagnosed with PCOS according to Rotterdam criteria\n7. Hydrosalpinx that hasn't been surgically removed or ligated.\n8. Untreated hyperprolactinemia\n9. Abnormal bleeding disorder\n10. Hepatic or renal dysfunction\n11. Hypersenstivity to study medication ( GNRH antagonist)\n12. Need to take medication that can influence ovarian stimulation\n13. Endometriosis grade 3 or 4\n14. Ovarian cyst\\> 10 cm."}, 'identificationModule': {'nctId': 'NCT03457233', 'briefTitle': 'The Impact of Body Weight on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Impact of Overweight and Obesity on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles', 'orgStudyIdInfo': {'id': '31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Normal weight', 'description': '18.5- 24.9 kg/m2', 'interventionNames': ['Drug: Gonadotropins', 'Drug: GNRH antagonist', 'Drug: Human chorionic gonadotropin Chorimon', 'Drug: Natural progesterone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Overweight', 'description': 'BMI 25-29.9 kg/m2', 'interventionNames': ['Drug: Gonadotropins', 'Drug: GNRH antagonist', 'Drug: Human chorionic gonadotropin Chorimon', 'Drug: Natural progesterone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Obese', 'description': 'BMI ≥ 30 kg/m2', 'interventionNames': ['Drug: Gonadotropins', 'Drug: GNRH antagonist', 'Drug: Human chorionic gonadotropin Chorimon', 'Drug: Natural progesterone']}], 'interventions': [{'name': 'Gonadotropins', 'type': 'DRUG', 'otherNames': ['Human menopausal gonadotropin'], 'description': '1\\) Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration', 'armGroupLabels': ['Normal weight', 'Obese', 'Overweight']}, {'name': 'GNRH antagonist', 'type': 'DRUG', 'otherNames': ['cetrorelix'], 'description': 'cetrorelix 0,25mg s.c is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration', 'armGroupLabels': ['Normal weight', 'Obese', 'Overweight']}, {'name': 'Human chorionic gonadotropin Chorimon', 'type': 'DRUG', 'otherNames': ['HCG'], 'description': '10000 IU of HCG are given intramuscular when 2 or more mature follicles reach 18 - 20 mm', 'armGroupLabels': ['Normal weight', 'Obese', 'Overweight']}, {'name': 'Natural progesterone', 'type': 'DRUG', 'otherNames': ['prontogest'], 'description': '400 mg vaginal tablets twice daily from the day of ovum pick up till HCG tesing', 'armGroupLabels': ['Normal weight', 'Obese', 'Overweight']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12111', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Maged, MD', 'role': 'CONTACT', 'email': 'prof.ahmedmaged@gmail.com', 'phone': '01005227404'}], 'facility': 'Kasr Alainy medical school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed Maged, MD', 'role': 'CONTACT', 'email': 'prof.ahmedmaged@gmail.com', 'phone': '+2001005227404'}, {'name': 'Radwa Fahmy, MD', 'role': 'CONTACT', 'email': 'radwafahmi@yahoo.com'}], 'overallOfficials': [{'name': 'Ahmed Maged', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Ahmed Maged', 'investigatorAffiliation': 'Cairo University'}}}}