Uterine Artery Doppler Changes After Vaginal Administration of Isosorbide Mononitrate In Patients With URPL

NCT05341856 | Unknown Early Phase 1

• 1 other identifier: isosorbide mononitrate in URPL
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

compare uterine artery blood flow before and after the administration of Isosorbide mononitrate as a nitric oxide donor during mid secretory phase of menstrual cycle for patients with unexplained recurrent pregnancy loss.

Conditions

Recurrent Pregnancy Loss

Outcome Measures

Primary Outcomes (1)

• Uterine Artery Doppler Changes After Vaginal Administration of Isosorbide Mononitrate In Patients with Unexplained Recurrent Pregnancy Loss

  compare uterine artery blood flow before and after the administration of Isosorbide mononitrate as a nitric oxide donor during mid secretory phase of menstrual cycle for patients with unexplained recurrent pregnancy loss.

  baseline

Study Arms (2)

Uterine artery Doppler Changes After IMN In Patients with URPL

ACTIVE COMPARATOR

compare uterine artery blood flow before and after the administration of Isosorbide mononitrate as a nitric oxide donor during mid secretory phase of menstrual cycle for patients with unexplained recurrent pregnancy loss.

Drug: isosorbide mononitrate; Drug: Placebo

Uterine artery Doppler Changes After placebo In Patients with URPL

PLACEBO COMPARATOR

compare uterine artery blood flow before and after the administration of placebo during mid secretory phase of menstrual cycle for patients with unexplained recurrent pregnancy loss.

Drug: isosorbide mononitrate; Drug: Placebo

Interventions

isosorbide mononitrate DRUG

insert vaginal tablet of isosorbide mononitrate in cases of unexplained recurrent pregnancy loss

Uterine artery Doppler Changes After IMN In Patients with URPL; Uterine artery Doppler Changes After placebo In Patients with URPL

Placebo DRUG

insert vaginal tablet of placebo in cases of unexplained recurrent pregnancy loss

Uterine artery Doppler Changes After IMN In Patients with URPL; Uterine artery Doppler Changes After placebo In Patients with URPL

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women age: 20-35 years.
• History of recurrent abortion (two or more successive spontaneous abortions) with :
• Normal HSG or hysteroscopy
• Normal serum PRL,
• Normal thyroid function,
• Normal HbA1c,
• Normal pelvic ultrasound
• Negative tests for antiphospholipid antibody syndrome (ACL, Lupus anticoagulant and anti B2 glycoprotein 1) Non pregnant state. Regular menstrual cycles for the previous three months before the study. No hormonal contraception or intrauterine devices. Not on any vasodilator drugs.

You may not qualify if:

• Age less or more than 20-35. Nulligravidae or nullipara. Infertile women. Induced abortion. Systemic diseases that might affect the hemodynamic indices as thrombocytopenia and thyrotoxicosis.
• Cases with uterine anomalies, uterine myomas, polypi and adnexal masses. History of oophorectomy. History of consanguinity. Family history of chromosomal abnormality as Down syndrome and Turner syndrome.

Sponsors & Collaborators

• Al-Azhar University: lead

Related Publications (7)

• Dimitriadis E, Menkhorst E, Saito S, Kutteh WH, Brosens JJ. Recurrent pregnancy loss. Nat Rev Dis Primers. 2020 Dec 10;6(1):98. doi: 10.1038/s41572-020-00228-z.

  PMID: 33303732 BACKGROUND

• El Hachem H, Crepaux V, May-Panloup P, Descamps P, Legendre G, Bouet PE. Recurrent pregnancy loss: current perspectives. Int J Womens Health. 2017 May 17;9:331-345. doi: 10.2147/IJWH.S100817. eCollection 2017.

  PMID: 28553146 BACKGROUND

• Mansour GM, Hussein SH, Abd El Hady RM, Mohammed HF, Abd El Gawad MM, Abou Gabal AI, Al-Awadhy RM, El Saied M. Uterine artery flow velocity waveform (FVW) type and subednometrial vascularity in recurrent pregnancy loss. J Matern Fetal Neonatal Med. 2020 Feb;33(4):527-532. doi: 10.1080/14767058.2018.1495190. Epub 2018 Aug 6.

  PMID: 29954242 BACKGROUND

• Taylor TJ, Quinton AE, de Vries BS, Hyett JA. First-trimester ultrasound features associated with subsequent miscarriage: A prospective study. Aust N Z J Obstet Gynaecol. 2019 Oct;59(5):641-648. doi: 10.1111/ajo.12944. Epub 2019 Feb 6.

  PMID: 30724337 BACKGROUND

• Yang W, Wu Z, Yu M, Peng X, Lu W, Feng W, Kang X. Characteristics of midluteal phase uterine artery hemodynamics in patients with recurrent pregnancy loss. J Obstet Gynaecol Res. 2019 Jul;45(7):1230-1235. doi: 10.1111/jog.13944. Epub 2019 Apr 11.

  PMID: 30977230 BACKGROUND

• Zhao Y, Vanhoutte PM, Leung SW. Vascular nitric oxide: Beyond eNOS. J Pharmacol Sci. 2015 Oct;129(2):83-94. doi: 10.1016/j.jphs.2015.09.002. Epub 2015 Sep 28.

  PMID: 26499181 BACKGROUND

• Zullino S, Buzzella F, Simoncini T. Nitric oxide and the biology of pregnancy. Vascul Pharmacol. 2018 Nov;110:71-74. doi: 10.1016/j.vph.2018.07.004. Epub 2018 Aug 1.

  PMID: 30076925 BACKGROUND

MeSH Terms

Interventions

isosorbide-5-mononitrate

Study Officials

• Ahmed Ali nasr, Professor

  Al-Azhar University

  STUDY DIRECTOR

Central Study Contacts

mostafa tolba ahmed, Resident

CONTACT

01119404838; mostafatolba@rocketmail.com

osama Abdelazem Hasan, Lecturer

CONTACT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Uterine Artery Doppler Changes After Vaginal Administration of Isosorbide Mononitrate In Patients with Unexplained Recurrent Pregnancy Loss

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 22, 2022
• Study Start: May 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04