Recurrent Pregnancy LossEarly Phase 1NCT05341856
Uterine Artery Doppler Changes After Vaginal Administration of Isosorbide Mononitrate In Patients With URPL
A Early Phase 1 study testing isosorbide mononitrate in people with Recurrent Pregnancy Loss, run by Al-Azhar University.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Recurrent Pregnancy Loss
- What is being tested?
- isosorbide mononitrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to Sep 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
osama Abdelazem Hasan, Lecturer contact
About this study
Official title: 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.
Read the detailed description
Recurrent pregnancy loss (RPL) is an important reproductive health issue, because it affects 2%-5% of couples. The incidence of RPL varies widely because of the differences in the definitions and criteria used, as well as the populations characteristics (El Hachem et al., 2017).
The reported incidence of early pregnancy loss depends on the method used to detect pregnancy. An estimated 50% of all conceptions are lost at preclinical stages owing to biochemical loss or implantation failure, further 9-20% of clinically recognized pregnancies are miscarried, mainly during the first trimester (weeks 5-12 of gestation), studies consistently demonstrate a sharp reduction after 12 weeks of gestation to an incidence of ~1% suggesting that most pregnancy losses occur soon after implantation (Dimitriadis et al., 2020).
The Royal College of Obstetricians and Gynecologists defines RPL as three or more consecutive pregnancy losses, The most recent RPL guideline from European Society of Human Reproduction and Embryology states that RPL could be considered after the loss of two or more pregnancies and stresses the importance of the need for further scientific research, including epidemiological studies on the effect of various RPL definitions on diagnosis, prognosis and treatment (ESHRE 2017).
Common established causes include uterine anomalies, antiphospholipid syndrome, hormonal and metabolic disorders, and cytogenetic abnormalities. Other etiologies have been proposed but are still considered controversial, such as chronic endometritis, inherited thrombophilia, luteal phase deficiency, and high sperm DNA fragmentation levels (Yang et al., 2019).
Over the years, evidence-based treatments such as surgical correction of uterine anomalies or aspirin and heparin for antiphospholipid syndrome have improved the outcomes for couples with recurrent pregnancy loss. However, almost half of the cases remain unexplained and are empirically treated using progesterone supplementation, anticoagulation, and/or immunomodulatory treatments. Regardless of the cause, the long-term prognosis of couples with recurrent pregnancy loss is good, and most eventually achieve a healthy live birth. However, multiple pregnancy losses can have a significant psychological toll on affected couples, and many efforts are being made to improve treatments and decrease the time needed to achieve a successful pregnancy (El Hachem et al., 2017).
Appropriate endometrial receptivity is vital in achieving a normal pregnancy, Inadequate uterine perfusion leading to endometrial and subendometrial hypoxia could induce low endometrial receptivity, which would increase spontaneous abortion (taylor et al; 2019 \& Mansour et al;2020).
Other studies also suggest that uterine perfusion may regulate endometrial receptivity, and that impaired uterine perfusion is one of the causes of URPL. In recent years, Doppler ultrasound with assessments of parameters of uterine artery and endometrium have become widely accepted when evaluating endometrial receptivity(Yang et al., 2019).
Nitric oxide (NO) is a gas and a free radical which is now recognized to have very important physiological roles. NO is important in the endothelium-dependent regulation of blood flow and pressure as well as inhibiting the activation of blood platelets. By this process , NO activates a haem-containing enzyme called soluble guanylyl cyclase which is activated a thousand fold to produce the signaling molecule cyclic GMP. This has many effects at the molecular level to set in train the pathways which propagate the diverse physiological actions of NO(Zhao et al., 2015).
NO plays important functional roles within vascular system, it induce vasodilation ,inhibit platelet aggregation and adhesion to endothelial cells, also inhibit smooth muscle proliferation ,regulates apoptosis and maintain endothelial barrier integrity. NO is the main vasodilator agent in the placenta ,which is the interface between mother and fetus ,and this is the reason why this molecule is crucial in different physiological aspect of pregnancy ,it is involved in implantation ,platelet adhesion ,early embryonic development .Related to placental perfusion, NO seem to influence cytotrophoblastic invasion during first stage of pregnancy and to mediate the remodeling of spiral arteries ,facilitating adequate blood supply to the growing fetus (Zullino et al., 2018).
- Conditions
- Recurrent Pregnancy Loss
- Being tested
- isosorbide mononitrate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isosorbide mononitrateDrug
insert vaginal tablet of isosorbide mononitrate in cases of unexplained recurrent pregnancy loss
PlaceboDrug
insert vaginal tablet of placebo in cases of unexplained recurrent pregnancy loss
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: isosorbide mononitrate; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Recurrent Pregnancy LossStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Tolba Ahmed, Al-Azhar University
- Investigators
- Ahmed Ali nasr, Professor, Study director, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341856
- Sponsor's protocol ID
- isosorbide mononitrate in URPL
- Status last verified
- Apr 2022
- First submitted
- 18 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33303732El 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.
PubMed 28553146Mansour 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.
PubMed 29954242Taylor 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.
PubMed 30724337Yang 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.
PubMed 30977230Zhao 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.
PubMed 26499181Zullino 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.
PubMed 30076925
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterine Artery Doppler Changes After Vaginal Administration of Isosorbide Mononitrate In Patients With Unexplained Recurrent Pregnancy Loss
- ClinicalTrials.gov ID
- NCT05341856
- Acronym / sponsor ID
- isosorbide mononitrate in URPL
- Conditions
- Recurrent Pregnancy Loss
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Recurrent pregnancy loss (RPL) is an important reproductive health issue, because it affects 2%-5% of couples. The incidence of RPL varies widely because of the differences in the definitions and criteria used, as well as the populations characteristics (El Hachem et al., 2017).
The reported incidence of early pregnancy loss depends on the method used to detect pregnancy. An estimated 50% of all conceptions are lost at preclinical stages owing to biochemical loss or implantation failure, further 9-20% of clinically recognized pregnancies are miscarried, mainly during the first trimester (weeks 5-12 of gestation), studies consistently demonstrate a sharp reduction after 12 weeks of gestation to an incidence of ~1% suggesting that most pregnancy losses occur soon after implantation (Dimitriadis et al., 2020).
The Royal College of Obstetricians and Gynecologists defines RPL as three or more consecutive pregnancy losses, The most recent RPL guideline from European Society of Human Reproduction and Embryology states that RPL could be considered after the loss of two or more pregnancies and stresses the importance of the need for further scientific research, including epidemiological studies on the effect of various RPL definitions on diagnosis, prognosis and treatment (ESHRE 2017).
Common established causes include uterine anomalies, antiphospholipid syndrome, hormonal and metabolic disorders, and cytogenetic abnormalities. Other etiologies have been proposed but are still considered controversial, such as chronic endometritis, inherited thrombophilia, luteal phase deficiency, and high sperm DNA fragmentation levels (Yang et al., 2019).
Over the years, evidence-based treatments such as surgical correction of uterine anomalies or aspirin and heparin for antiphospholipid syndrome have improved the outcomes for couples with recurrent pregnancy loss. However, almost half of the cases remain unexplained and are empirically treated using progesterone supplementation, anticoagulation, and/or immunomodulatory treatments. Regardless of the cause, the long-term prognosis of couples with recurrent pregnancy loss is good, and most eventually achieve a healthy live birth. However, multiple pregnancy losses can have a significant psychological toll on affected couples, and many efforts are being made to improve treatments and decrease the time needed to achieve a successful pregnancy (El Hachem et al., 2017).
Appropriate endometrial receptivity is vital in achieving a normal pregnancy, Inadequate uterine perfusion leading to endometrial and subendometrial hypoxia could induce low endometrial receptivity, which would increase spontaneous abortion (taylor et al; 2019 \& Mansour et al;2020).
Other studies also suggest that uterine perfusion may regulate endometrial receptivity, and that impaired uterine perfusion is one of the causes of URPL. In recent years, Doppler ultrasound with assessments of parameters of uterine artery and endometrium have become widely accepted when evaluating endometrial receptivity(Yang et al., 2019).
Nitric oxide (NO) is a gas and a free radical which is now recognized to have very important physiological roles. NO is important in the endothelium-dependent regulation of blood flow and pressure as well as inhibiting the activation of blood platelets. By this process , NO activates a haem-containing enzyme called soluble guanylyl cyclase which is activated a thousand fold to produce the signaling molecule cyclic GMP. This has many effects at the molecular level to set in train the pathways which propagate the diverse physiological actions of NO(Zhao et al., 2015).
NO plays important functional roles within vascular system, it induce vasodilation ,inhibit platelet aggregation and adhesion to endothelial cells, also inhibit smooth muscle proliferation ,regulates apoptosis and maintain endothelial barrier integrity. NO is the main vasodilator agent in the placenta ,which is the interface between mother and fetus ,and this is the reason why this molecule is crucial in different physiological aspect of pregnancy ,it is involved in implantation ,platelet adhesion ,early embryonic development .Related to placental perfusion, NO seem to influence cytotrophoblastic invasion during first stage of pregnancy and to mediate the remodeling of spiral arteries ,facilitating adequate blood supply to the growing fetus (Zullino et al., 2018).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uterine artery Doppler Changes After IMN In Patients with URPL | Active comparator | Drug: isosorbide mononitrate, Drug: Placebocompare 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. |
| Uterine artery Doppler Changes After placebo In Patients with URPL | Placebo comparator | Drug: isosorbide mononitrate, Drug: Placebocompare 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Women age: 20-35 years.
- Normal HSG or hysteroscopy
- Normal serum PRL,
- Normal thyroid function,
- Normal HbA1c,
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isosorbide mononitrateinsert vaginal tablet of isosorbide mononitrate in cases of unexplained recurrent pregnancy loss | Drug | Uterine artery Doppler Changes After IMN In Patients with URPL, Uterine artery Doppler Changes After placebo In Patients with URPL |
| Placeboinsert vaginal tablet of placebo in cases of unexplained recurrent pregnancy loss | Drug | Uterine artery Doppler Changes After IMN In Patients with URPL, Uterine artery Doppler Changes After placebo In Patients with URPL |
Primary outcome
Uterine Artery Doppler Changes After Vaginal Administration of Isosorbide Mononitrate In Patients with Unexplained Recurrent Pregnancy Loss
Time frame: baseline
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Background: PubMed 33303732Dimitriadis 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.
- Background: PubMed 28553146El 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.
- Background: PubMed 29954242Mansour 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.
- Background: PubMed 30724337Taylor 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.
- Background: PubMed 30977230Yang 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.
- Background: PubMed 26499181Zhao 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.
- Background: PubMed 30076925Zullino 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
osama Abdelazem Hasan, Lecturer contact
Ahmed Ali nasr, Professor study director
Al-Azhar University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing isosorbide mononitrate in people with Recurrent Pregnancy Loss, run by Al-Azhar University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mostafa tolba ahmed, Resident (01119404838, mostafatolba@rocketmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uterine Artery Doppler Changes After Vaginal Administration of Isosorbide Mononitrate In Patients with Unexplained Recurrent Pregnancy Loss (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05341856, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.