Ignite Creation Date:
2025-12-24 @ 10:15 PM
Ignite Modification Date:
2025-12-25 @ 7:49 PM
Study NCT ID:
NCT04283435
Status:
UNKNOWN
Last Update Posted:
2021-08-20
First Post:
2020-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endometrial Effects of Sildenafil in Frozen-Thawed Cycles in Women With Thin Endometrium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068677', 'term': 'Sildenafil Citrate'}, {'id': 'D004958', 'term': 'Estradiol'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'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'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'One hundred envelopes will be numbered serially and in each envelope the corresponding letter which denotes the allocated group will be put according to randomization table. When the first patient arrives, the first envelope will be opened and the patient will be allocated according to the letter inside.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-14', 'studyFirstSubmitDate': '2020-02-18', 'studyFirstSubmitQcDate': '2020-02-21', 'lastUpdatePostDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Pregnancy rate', 'timeFrame': '2 weeks after embryo transfer'}], 'secondaryOutcomes': [{'measure': 'endometrial thickness', 'timeFrame': 'at the time of embryo transfer'}, {'measure': 'Endometrial volume', 'timeFrame': 'at the time of embryo transfer'}, {'measure': 'Uterine artery doppler indices', 'timeFrame': 'at the time of embryo transfer'}, {'measure': '3D endometrial and subendometrial vascular indices(VI,FI.VFI)', 'timeFrame': 'at the time of embryo transfer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['IVF', 'Endometrial Receptivity']}, 'descriptionModule': {'briefSummary': 'Management of Thin endometrium in IVF is challenging. Thin endometrium is often defined as \\<7 mm or \\< 8 mm on the day of Human Gonadotropin administration(Bu and Sun, 2015; Wu et al., 2014).\n\nIts incidence is 1-2.5% in most studies ( AlGhamdi et al.,2008).\n\nEndometrial thickness and endometrial vascularity is closely linked to endometrial receptivity.Improving endometrial receptivity is a predictor of the success in IVF.\n\nMany medications have been tried to improve endometrial thickness as Aspirin,sildenafil citrate,luteal estradiol and Granulocyte colony stimulating factor.\n\nNitric oxide (NO) is a key signaling molecule involved in the vasodilator response of smooth muscle cells. NO activates the cyclic guanosine monophosphate (cGMP)/protein kinase G (PKG) pathway within smooth muscle cells to promote smooth muscle cell relaxation. Sildenafil citrate inhibits phosphodiesterase 5 (PDE5) maintaining activation of cGMP and PKG and maximizing the effect of existing NO, thus facilitating smooth muscle cell relaxation. The potent vasodilator action of sildenafil has led researchers to evaluate sildenafil as a treatment in assisted reproduction where low uterine blood flow is perceived to be a contributor to implantation failure (Fairouzabadi et al.2013).\n\nThe investigators aim at this study to investigate the role of sildenafil citrate on endometrial and subendometrial vasculature in women with thin endometrium undergoing Frozen-Thawed IVF cycles.', 'detailedDescription': 'This is a Randomised-controlled trial .The investigators recruited 100 women who are known to have thin endometrium in previous IVF cycles (failed/cancelled cycles).\n\nThey are randomised into group A (50 women) : preparation of the endometrium with Estradiol valerate 2mg/day (every 8 hours)(white tablets of cycloprogenova,Payer,Germany) from the first day of the cycle till 12th day and The investigators add placebo from the first day of the cycle till the day of starting progesterone (It will be stopped 3 days before embryo transfer).Group B (50 women): The investigators add Sildenafil citrate (Viagra,pfizer,United states) to the estradiol valerate. Sildenafil 50 mg will be used daily from the first day of the cycle till the day of starting progesterone (It will be stopped 3 days before embryo transfer). The embryos will be transferred depending on their age on day 3 or day 5.\n\nAt the transfer date ,the investigators will assess the endometrial thickness, endometrial volume, uterine artery doppler indices (RI,PI) as well as 3D endometrial vascular indices (VI,FI,VFI) .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '25 Years', 'genderBased': True, 'genderDescription': 'Females undergoing IVF', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women (25 -40 years) undergoing IVF frozen-Thawed cycles and known to have good quality embryos.\n* previous thin endometrium (\\< 8mm on at least 3 previous cycles) with normal Hysteroscopy findings\n\nExclusion Criteria:\n\n* women less than 25 years old or more than 40 years old.\n* abnormal hysteroscopic findings.\n* women with congenital uterine anomalies.\n* History of previous uterine surgery\n* Any contraindication to Sildenafil as Previous history of cardiac disease or stroke.'}, 'identificationModule': {'nctId': 'NCT04283435', 'briefTitle': 'Endometrial Effects of Sildenafil in Frozen-Thawed Cycles in Women With Thin Endometrium', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Sildenafil on Uterine and Endometrial Vasculature in Women With Thin Endometrium Having Frozen-Thawed IVF Cycles', 'orgStudyIdInfo': {'id': 'PROTOCOL 500'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'estradiol valerate + placebo', 'description': 'preparation of the endometrium with Estradiol valerate 2mg/day (every 8 hours)(white tablets of cycloprogenova) .from the first day of the cycle till 12th day and we add placebo from the first day of the cycle till the day of start progesterone (we stop 3 days before embryo transfer).', 'interventionNames': ['Other: Placebo', 'Drug: Estradiol Valerate']}, {'type': 'EXPERIMENTAL', 'label': 'estradiol valerate + Sildenafil citrate', 'description': 'We add Sildenfil citrate 50 mg daily from the first day of the period till the day of starting the progesterone. and stop 3 days before the embryo transfer.', 'interventionNames': ['Drug: Sildenafil Citrate', 'Drug: Estradiol Valerate']}], 'interventions': [{'name': 'Sildenafil Citrate', 'type': 'DRUG', 'description': 'Sildenafil Citrate 50 mg tablets taken from the first day of the cycle till the day we start progesterone (we stop 3 days before embryo transfer)', 'armGroupLabels': ['estradiol valerate + Sildenafil citrate']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Pregnacare vitamins (Vitabiotics,UK)'], 'description': 'Placebo tablet (multivitamins),Pregnacare vitamins (Vitabiotics,UK)', 'armGroupLabels': ['estradiol valerate + placebo']}, {'name': 'Estradiol Valerate', 'type': 'DRUG', 'description': 'Estradiol valerate tablets 2mg every 8 hours daily starting from the fist day of the cycle till 12th day of the menstrual cycle.', 'armGroupLabels': ['estradiol valerate + Sildenafil citrate', 'estradiol valerate + placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Eman Elkattan, MD', 'role': 'CONTACT', 'email': 'emyelkattan@gmail.com', 'phone': '01212529213'}, {'name': 'wafaa Ramadan, MD', 'role': 'CONTACT', 'phone': '01019944328'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Eman Elkattan', 'investigatorAffiliation': 'Cairo University'}}}}