Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2026-01-06 @ 9:46 AM
Study NCT ID:
NCT03398993
Status:
UNKNOWN
Last Update Posted:
2018-01-16
First Post:
2018-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Endometrial Injury in Couples With Unexplained Infertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002996', 'term': 'Clomiphene'}, {'id': 'D006063', 'term': 'Chorionic Gonadotropin'}, {'id': 'C527545', 'term': 'hMG-IBSA'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-08', 'studyFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2018-01-08', 'lastUpdatePostDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical pregnancy rate', 'timeFrame': '4 weeks after missed period', 'description': 'intrauterine gestational sac'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Unexplained Infertility']}, 'descriptionModule': {'briefSummary': '100 patient of unexplained infertility recruited and divided into two groups for the study group (50) endometrial scratching done in preovulatory period after controlled ovarian stimulation by clomiphene citrate , then followed and compared to control group for 6 months to asses pregnancy rate', 'detailedDescription': "Induction of ovulation was done by clomophine citrate (selective estrogen modulator of triphenylethylene group, produced by( Sanafi Aventis company) from 3rd day of cycle till 7th day of cycle and HMG 75IU (MerionaL) produced by IBSA ( Institute biochimique SA) given from 6th day of cycle till 8th of cycle once daily. folliculometry done regularly during induction of ovulation till dominant follicle reached 18\\_20mm in size.\n\nThen endometrial injury performed in pre ovulatory day by a thin pipelle (a fine, flexible, sterile, plastic tube) produced by Jiangsu Guard King Medical Equipment Co.\n\nThe procedure was carried out in preovulatory day (known when dominant follicle reached 18\\_20 mm in diameter), usually, done around day 14-day of the cycle.\n\nIn the theatre, Patients put in a lithotomy position, sterilization was performed with the presence of good source of light., the procedure was carried out using a thin pipelle tube as follow :- A cuscoe's speculum was inserted into the vagina in order to visualize the cervix.\n\nCervix was grasped by vollselum upwards backwards, then pipelle tube passed through the cervix and uterine cavity, then moved up and down to make a single induced scratch two times in the lining endometrium of posterior wall of uterus.\n\nThe procedure took approximately 15minutes to complete. It was uncomfortable or painful in some circumstances and that bleeding after the procedure happened in many cases. Post procedure antibiotics were given.\n\nCouples were advised to practice timed sexual intercourse for next 6months and couples in both groups were asked to phone a contact Person whenever there was a missed period. The patients followed up for six months for detecion of the biochemical pregnancy if occurred.\n\n2- Control group (50patients) :- They received the same induction of ovulation as first group but without performing endometrial injury in preovulatory day.\n\nWe wait till time of period if missed period achieved serum pregnancy test done after one week of missed period .\n\nAll women followed for 6 months after treatment. Comparative study was done for both groups and results presented in tables and statistically analyzed"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unexplained infertility ( 1ry \\& 2ndry infertility) : \\*\n\n * Normal hormonal profile of infertile woman.\n * Normal hystrosalpingogram.\n * Normal laparoscopy.\n * Normal investigation of the cervical factor\n * Fertile semen analysis (according to world health organization criteria 2015).\n\nExclusion Criteria:\n\n* • Infertile semen analysis.\n\n * Abnormal HSG.\n * Abnormal laparoscopic findings.\n * Disturbed hormonal profile.\n * Evidence of cervical factor.\n * Known genetic disorder\n * Known autoimmune disease'}, 'identificationModule': {'nctId': 'NCT03398993', 'briefTitle': 'Effect of Endometrial Injury in Couples With Unexplained Infertility', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Study of Pregnancy Rate After Endometrial Injury in Couples With Unexplained Infertility', 'orgStudyIdInfo': {'id': '17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Scratch group', 'description': 'Induction of ovulation will be done by clomophine citrate from 3rd day of cycle till 7th day of cycle and HMG 75IU (MerionaL) given from 6th day of cycle till 8th of cycle once daily. folliculometry done regularly during induction of ovulation till dominant follicle reached 18\\_20mm in size.\n\nThen endometrial injury performed in pre ovulatory day by a thin pipelle (a fine, flexible, sterile, plastic tube) The procedure was carried out in preovulatory day (known when dominant follicle reached 18\\_20 mm in diameter), usually, done around day 14-day of the cycle', 'interventionNames': ['Drug: Clomiphene Citrate', 'Drug: Human chorionic gonadotropin', 'Device: Endometrial scratch']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non scratch group', 'description': 'They will receive the same induction of ovulation as first group but without performing endometrial injury in preovulatory day', 'interventionNames': ['Drug: Clomiphene Citrate', 'Drug: Human chorionic gonadotropin']}], 'interventions': [{'name': 'Clomiphene Citrate', 'type': 'DRUG', 'otherNames': ['clomid'], 'description': '50 mg twice daily from3rd day of cycle till 7th day of cycle', 'armGroupLabels': ['Non scratch group', 'Scratch group']}, {'name': 'Human chorionic gonadotropin', 'type': 'DRUG', 'otherNames': ['MerionaL'], 'description': '75 IU dail;y from 6th day of cycle till 8th of cycle once daily', 'armGroupLabels': ['Non scratch group', 'Scratch group']}, {'name': 'Endometrial scratch', 'type': 'DEVICE', 'description': "The procedure was carried out in preovulatory day (known when dominant follicle reached 18\\_20 mm in diameter), usually, done around day 14-day of the cycle.\n\nIn the theatre, Patients put in a lithotomy position, sterilization was performed with the presence of good source of light., the procedure was carried out using a thin pipelle tube as follow :- A cuscoe's speculum was inserted into the vagina in order to visualize the cervix.\n\nCervix was grasped by vollselum upwards backwards, then pipelle tube passed through the cervix and uterine cavity, then moved up and down to make a single induced scratch two times in the lining endometrium of posterior wall of uterus.\n\nThe procedure took approximately 15minutes to complete", 'armGroupLabels': ['Scratch group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12151', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Alainy medical school', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ahmed maged', 'role': 'CONTACT', 'email': 'dr_ahmedmaged08@kasralainy.edu.eg', 'phone': '+20201005227404'}, {'name': 'ameer elsherief', 'role': 'CONTACT', 'email': 'ameerelsherief@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'}}}}