MiscarriageNCT07109947
Use of Aromatase Inhibitor Before Misoprostol in Medical Termination of Miscarriage
A study testing Letrozole 2.5mg in people with Miscarriage, run by Aswan University at 1 site in Egypt.
Trial summary
Abortion is one of the most common complications of pregnancy. Missed abortion is a type of abortions, occurs in 15%-20% of clinically diagnosed pregnancies and is defined as the retention of pregnancy products in the uterus for several days or weeks after death of the fetus. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Miscarriage
- What is being tested?
- Letrozole 2.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2025to 10 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Missed or anembryonic pregnancy.
- Gestational age from 4 weeks to 26 weeks of pregnancy (confirmed by ultrasound scanning on first day of admittance).
- Hemoglobin level more than 9g/l.
- Closed cervix.
- No product of conception in the cervical canal.
Who cannot join
- Previous attempt to terminate the pregnancy.
- Molar pregnancy
- Abnormal uterine lesions such as fibroids or congenital mal formations.
- Pregnancy despite of intrauterine contraceptive device.
- Medical disorders as cardiac, renal or hemorrhagic diseases.
- BMI more than 35 kg/m2.
- Known hypersensitivity to any of the medication used.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University Hospital
Aswān
Amr Shahata Abd Elbadee, Assist.Prof, +201007221659, Love_like902@yahoo.com
About this study
Official title: Comparison Between the Use of Aromatase Inhibitor Before Misoprostol and Use of Misoprostol Alone in Medical Termination of Miscarriage
Abortion is one of the most common complications of pregnancy. Missed abortion is a type of abortions, occurs in 15%-20% of clinically diagnosed pregnancies and is defined as the retention of pregnancy products in the uterus for several days or weeks after death of the fetus.
Read the detailed description
Various medical and surgical methods have been used to manage missed abortions. Surgical methods include dilatation and curettage, and vacuum aspiration. Because these methods are expensive and involve anesthesia, however, medical methods are generally preferred over surgical methods for abortion.
Medical approaches include misoprostol which is a prostaglandin that causes myometrial contractions, cervical softening and dilatation. It is used to induce abortion and labor and to treat atonic postpartum hemorrhage and peptic ulcers.
It has the advantage of being cost-effective and stable with a low rate of side effects which has led to it being included in the World Health Organization list of essential medications (2014). Misoprostol is licensed for use to induce miscarriage in Egypt. It has not been licensed to induce labor or miscarriage in certain countries such as Germany, but it is used off-label to induce labor in the UK.
Usage of Misoprostol alone has a success rate of between 65 and 93% especially in the early stages of pregnancy. It can also use in combination with other medications such as mifepristone and methotrexate to increase the success rate.
Most studies have examined the effect of letrozole plus misoprostol on the abortion of live embryos .Given the significance of specifying an effective and safe method for termination of abortion and the specific features of letrozole, such as its safety, cost-effectiveness, and availability.
- Conditions
- Miscarriage
- Being tested
- Letrozole 2.5mg
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole 2.5mgDrug
Also called Misoprestol
to determine the effect of Letrozole as a premedication before misoprostol treatment used to induce missed miscarriage.
| Study group | Role | What they receive |
|---|---|---|
| Group A: letrozole and Misoprostol | Active comparator | About 35 pregnant women will receive aromatase inhibitor (letrozole) 2.5 mg tablet three times daily for 3 days followed by two doses of 400 micrograms of misoprostol administered vaginally on the 4th day of enrolment (two 200-μg tablets spaced 4 hours apart). Receives: Drug: Letrozole 2.5mg |
| Group B: Misoprostol | Active comparator | About 35 pregnant women will receive two doses of 400 µg of vaginal misoprostol (two 200-μg tablets spaced 4 hours apart). Receives: Drug: Letrozole 2.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Miscarriage Achievement
The induction-to-abortion interval in each group
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start10 Jul 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MiscarriageStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arwa Ashraf Saeed, Aswan University
- Investigators
- Hani Ahmed Farouk, Assist.Prof., Study chair, Obstetrics and Gynecology,Faculty of Medicine,Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109947
- Sponsor's protocol ID
- Arwa Ashraf
- Status last verified
- Jul 2025
- First submitted
- 31 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Use of Aromatase Inhibitor Before Misoprostol and Use of Misoprostol Alone in Medical Termination of Miscarriage
- ClinicalTrials.gov ID
- NCT07109947
- Acronym / sponsor ID
- Arwa Ashraf
- Conditions
- Miscarriage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 10 Dec 2025 (estimated)
- First posted
- 7 Aug 2025 (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.
Abortion is one of the most common complications of pregnancy. Missed abortion is a type of abortions, occurs in 15%-20% of clinically diagnosed pregnancies and is defined as the retention of pregnancy products in the uterus for several days or weeks after death of the fetus.
Detailed description
Various medical and surgical methods have been used to manage missed abortions. Surgical methods include dilatation and curettage, and vacuum aspiration. Because these methods are expensive and involve anesthesia, however, medical methods are generally preferred over surgical methods for abortion.
Medical approaches include misoprostol which is a prostaglandin that causes myometrial contractions, cervical softening and dilatation. It is used to induce abortion and labor and to treat atonic postpartum hemorrhage and peptic ulcers.
It has the advantage of being cost-effective and stable with a low rate of side effects which has led to it being included in the World Health Organization list of essential medications (2014). Misoprostol is licensed for use to induce miscarriage in Egypt. It has not been licensed to induce labor or miscarriage in certain countries such as Germany, but it is used off-label to induce labor in the UK.
Usage of Misoprostol alone has a success rate of between 65 and 93% especially in the early stages of pregnancy. It can also use in combination with other medications such as mifepristone and methotrexate to increase the success rate.
Most studies have examined the effect of letrozole plus misoprostol on the abortion of live embryos .Given the significance of specifying an effective and safe method for termination of abortion and the specific features of letrozole, such as its safety, cost-effectiveness, and availability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: letrozole and Misoprostol | Active comparator | Drug: Letrozole 2.5mgAbout 35 pregnant women will receive aromatase inhibitor (letrozole) 2.5 mg tablet three times daily for 3 days followed by two doses of 400 micrograms of misoprostol administered vaginally on the 4th day of enrolment (two 200-μg tablets spaced 4 hours apart). |
| Group B: Misoprostol | Active comparator | Drug: Letrozole 2.5mgAbout 35 pregnant women will receive two doses of 400 µg of vaginal misoprostol (two 200-μg tablets spaced 4 hours apart). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Missed or anembryonic pregnancy.
- Gestational age from 4 weeks to 26 weeks of pregnancy (confirmed by ultrasound scanning on first day of admittance).
- Hemoglobin level more than 9g/l.
- Closed cervix.
- No product of conception in the cervical canal.
Key exclusion criteria (7 listed)
- Previous attempt to terminate the pregnancy.
- Molar pregnancy
- Abnormal uterine lesions such as fibroids or congenital mal formations.
- Pregnancy despite of intrauterine contraceptive device.
- Medical disorders as cardiac, renal or hemorrhagic diseases.
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 |
|---|---|---|
| Letrozole 2.5mgAlso: Misoprestolto determine the effect of Letrozole as a premedication before misoprostol treatment used to induce missed miscarriage. | Drug | Group A: letrozole and Misoprostol, Group B: Misoprostol |
Primary outcome
Miscarriage Achievement
Time frame: 10 days
The induction-to-abortion interval in each group
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Undecided
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The Psychological Effects of Miscarriage Prediction Score: A Prospective Study
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Efficacy of Progesterone and Low Molecular Weight Heparin in Recurrent Pregnancy Loss
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Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
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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.
Hani Ahmed Farouk, Assist.Prof. study chair
Obstetrics and Gynecology,Faculty of Medicine,Aswan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Letrozole 2.5mg in people with Miscarriage, run by Aswan University at 1 site in Egypt.
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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arwa Ashraf Saeed, MSC (+201013302339, Arwa170439@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Miscarriage Achievement (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2025.