Evening Primorose OilNCT07641595
Evening Primorose Oil Versus Misoprostol in Cervical Preparation Before Operative Hysteroscopy
A study testing Primorose Oil and Misoprostol in people with Evening Primorose Oil and Misoprostol, run by Sohag University at 1 site in Egypt.
Trial summary
This study aimed to compare the efficacy of misoprostol versus intravaginal Evening Primrose Oil capsule as a cervical ripening agent prior to operative hysteroscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Evening Primorose Oil, Misoprostol, Cervical Preparation
- What is being tested?
- Primorose Oil and Misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Nov 2024to 21 May 2026
- Phase
- Interventional
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range from 18-65 years
- Patients need operative hysteroscopy
Who cannot join
- Pregnant women.
- Incompetent cervix.
- History of cervical operations like conization.
- Contraindications for both drugs (women with bleeding disorders, consumers of anticoagulants, schizophrenic individuals receiving phenothiazine, epileptics and those on medication for antihypertension).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Evening Primorose Oil Versus Misoprostol in Cervical Preparation Before Operative Hysteroscopy
This study aimed to compare the efficacy of misoprostol versus intravaginal Evening Primrose Oil capsule as a cervical ripening agent prior to operative hysteroscopy.
Read the detailed description
Hysteroscopy is an operative procedure in which the gynaecologist directly examines the uterine cavity using a small telescopic instrument (hysteroscope) inserted via the vagina and the cervix.
Misoprostol is a synthetic Prostaglandins (PGE1) analogue that has been found to be a safe and inexpensive agent for cervical ripening. It is one of the most studied cervical ripening agents used prior to hysteroscopy.
Evening primrose oil is derived from the seeds of the evening primrose (Oenothera biennis) plant. It is rich in the essential fatty acid gamma linolenic acid, a fatty acid that the body converts to a hormone like substance called prostaglandin E1.
- Conditions
- Evening Primorose Oil, Misoprostol, Cervical Preparation, Hysteroscopy
- Being tested
- Primorose Oil, Misoprostol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primorose OilOther
Patients received evening Primorose Oil.
MisoprostolOther
Patients received Misoprostol.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients received evening Primorose Oil. Receives: Other: Primorose Oil |
| Group II | Experimental | Patients received Misoprostol. Receives: Other: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of cervical Ripening
Cervical ripening assessed by the interval between insertion of Hegar dilators size 3 and size 10, and by the size of the first Hegar dilator requiring forceful insertion.
Measured: During operative hysteroscopy (2 hours after vaginal administration of the study medication)
Secondary outcomes (4)
Cervical Bleeding
Occurrence of cervical bleeding during cervical entry was recorded.
Measured: During operative hysteroscopy (2 hours after vaginal administration of the study medication)
False Passage Formation
Occurrence of false passage during cervical instrumentation was recorded.
Measured: During operative hysteroscopy (2 hours after vaginal administration of the study medication)
Cervical Laceration
Occurrence of cervical laceration during cervical dilatation was recorded.
Measured: During operative hysteroscopy (2 hours after vaginal administration of the study medication)
Incidence of drug-related adverse effects
Incidence of drug-related adverse effects such as the occurrence of nausea, vomiting, diarrhea, fever, and severe abdominal pain were recorded.
Measured: Until completion of the procedure (Up to 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start12 Nov 2024
- Primary completion21 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evening Primorose OilStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Mahmoud Ahmed Elkhalily, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07641595
- Sponsor's protocol ID
- Soh-Med-24-11--7PD
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Evening Primorose Oil Versus Misoprostol in Cervical Preparation Before Operative Hysteroscopy
- ClinicalTrials.gov ID
- NCT07641595
- Acronym / sponsor ID
- Soh-Med-24-11--7PD
- Conditions
- Evening Primorose Oil, Misoprostol, Cervical Preparation, Hysteroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 21 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 11 Jun 2026 (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.
This study aimed to compare the efficacy of misoprostol versus intravaginal Evening Primrose Oil capsule as a cervical ripening agent prior to operative hysteroscopy.
Detailed description
Hysteroscopy is an operative procedure in which the gynaecologist directly examines the uterine cavity using a small telescopic instrument (hysteroscope) inserted via the vagina and the cervix.
Misoprostol is a synthetic Prostaglandins (PGE1) analogue that has been found to be a safe and inexpensive agent for cervical ripening. It is one of the most studied cervical ripening agents used prior to hysteroscopy.
Evening primrose oil is derived from the seeds of the evening primrose (Oenothera biennis) plant. It is rich in the essential fatty acid gamma linolenic acid, a fatty acid that the body converts to a hormone like substance called prostaglandin E1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Primorose OilPatients received evening Primorose Oil. |
| Group II | Experimental | Other: MisoprostolPatients received Misoprostol. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age range from 18-65 years
- Patients need operative hysteroscopy
Key exclusion criteria (4 listed)
- Pregnant women.
- Incompetent cervix.
- History of cervical operations like conization.
- Contraindications for both drugs (women with bleeding disorders, consumers of anticoagulants, schizophrenic individuals receiving phenothiazine, epileptics and those on medication for antihypertension).
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 |
|---|---|---|
| Primorose OilPatients received evening Primorose Oil. | Other | Group I |
| MisoprostolPatients received Misoprostol. | Other | Group II |
Primary outcome
Assessment of cervical Ripening
Time frame: During operative hysteroscopy (2 hours after vaginal administration of the study medication)
Cervical ripening assessed by the interval between insertion of Hegar dilators size 3 and size 10, and by the size of the first Hegar dilator requiring forceful insertion.
4 secondary outcomes
Cervical Bleeding
Time frame: During operative hysteroscopy (2 hours after vaginal administration of the study medication)
False Passage Formation
Time frame: During operative hysteroscopy (2 hours after vaginal administration of the study medication)
Cervical Laceration
Time frame: During operative hysteroscopy (2 hours after vaginal administration of the study medication)
Incidence of drug-related adverse effects
Time frame: Until completion of the procedure (Up to 2 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primorose Oil and Misoprostol in people with Evening Primorose Oil and Misoprostol, run by Sohag 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 11 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of cervical Ripening (time frame: During operative hysteroscopy (2 hours after vaginal administration of the study medication)). 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 11 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.