Menstrual CycleNCT07539831
Effects of Menstrual Cycle on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Gynecologic Surgery
An observational study of Menstrual Cycle and Optic Nerve Sheath Diameter, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This observational study aims to evaluate the effect of menstrual cycle phase on optic nerve sheath diameter (ONSD) in women undergoing elective laparoscopic gynecologic surgery. Patients will be grouped according to menstrual cycle phase as follicular or luteal. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Menstrual Cycle, Optic Nerve Sheath Diameter, Postoperative Nausea and Vomiting
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2026to 5 Apr 2027
- Phase
- Observational
- 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
Study population: Women aged 18 to 45 years with ASA physical status I-II who are scheduled for elective laparoscopic gynecologic surgery at Konya City Hospital. Participants will be observed according to menstrual cycle phase (follicular or luteal phase).
Who may be able to join
- Female patients aged 18 to 45 years
- Scheduled for elective laparoscopic gynecologic surgery
- Menstrual cycle in the follicular phase or luteal phase
- American Society of Anesthesiologists (ASA) physical status I-II
Who cannot join
- Irregular menstrual cycle (e.g., polycystic ovary syndrome, early menopause, hypothalamic amenorrhea)
- Pregnancy or breastfeeding
- Neurological disease associated with intracranial pressure changes
- Glaucoma or another eye disease associated with high intraocular pressure
- Previous brain surgery
- Uncontrolled hypertension or severe cardiovascular disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
MAHMUT TUTAR, md contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Konya City Hospital
Konya
MAHMUT TUTAR, MD, 905552723704, masatu42@gmail.com
MAHMUT TUTAR
About this study
Official title: The Effect of Menstrual Cycle Phase on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Gynecologic Surgery
This observational study aims to evaluate the effect of menstrual cycle phase on optic nerve sheath diameter (ONSD) in women undergoing elective laparoscopic gynecologic surgery. Patients will be grouped according to menstrual cycle phase as follicular or luteal. ONSD measurements will be performed perioperatively, and postoperative nausea and vomiting as well as postoperative cognitive function will also be assessed. The study is designed to investigate whether hormonal variations during the menstrual cycle are associated with differences in intracranial pressure reflected by ONSD measurements and postoperative outcomes
- Keywords
- Optic Nerve Sheath Diameter, Laparoscopic Gynecologic Surgery, Mini-Mental State Examination, Verbal Descriptive Scale, Follicular Phase, Luteal Phase
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Follicular Phase | Women undergoing elective laparoscopic gynecologic surgery during the follicular phase of the menstrual cycle (approximately days 12-14). Perioperative optic nerve sheath diameter measurements will be performed, and postoperative nausea, vomiting, and cognitive function will be assessed. | |
| Luteal Phase | Women undergoing elective laparoscopic gynecologic surgery during the luteal phase of the menstrual cycle (approximately days 20-25). Perioperative optic nerve sheath diameter measurements will be performed, and postoperative nausea, vomiting, and cognitive function will be assessed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic Nerve Sheath Diameter
The primary outcome is the comparison of optic nerve sheath diameter (ONSD) between women in the follicular phase and those in the luteal phase of the menstrual cycle undergoing elective laparoscopic gynecologic surgery. ONSD will be measured ultrasonographically in the supine position. For each eye, three horizontal and three vertical measurements will be obtained and averaged.
Measured: Before induction of anesthesia, during surgery, and at the end of surgery
Secondary outcomes (2)
Postoperative Nausea and Vomiting
Postoperative nausea and vomiting will be assessed using the Verbal Descriptive Scale (VDS) and compared between the follicular-phase and luteal-phase groups. The VDS categories are none, mild, moderate, vomiting once, and severe vomiting.
Measured: Within 24 hours after surgery
Postoperative Cognitive Function
Postoperative cognitive function will be assessed using the Mini-Mental State Examination (MMSE) and compared between the follicular-phase and luteal-phase groups.
Measured: Preoperative period and 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start20 Apr 2026
- Primary completion3 Mar 2027 (estimated)
- Study completion5 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual CycleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmut Sami TUTAR, Konya City Hospital
- Investigators
- MAHMUT TUTAR, MD, Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539831
- Sponsor's protocol ID
- KSH-ANEST-2025-ONSD-01
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Menstrual Cycle Phase on Optic Nerve Sheath Diameter in Patients Undergoing Laparoscopic Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT07539831
- Acronym / sponsor ID
- KSH-ANEST-2025-ONSD-01
- Keywords
- Optic Nerve Sheath Diameter, Laparoscopic Gynecologic Surgery, Mini-Mental State Examination, Verbal Descriptive Scale, Follicular Phase, Luteal Phase
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 3 Mar 2027 (estimated)
- Study completion
- 5 Apr 2027 (estimated)
- First posted
- 20 Apr 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 observational study aims to evaluate the effect of menstrual cycle phase on optic nerve sheath diameter (ONSD) in women undergoing elective laparoscopic gynecologic surgery. Patients will be grouped according to menstrual cycle phase as follicular or luteal. ONSD measurements will be performed perioperatively, and postoperative nausea and vomiting as well as postoperative cognitive function will also be assessed. The study is designed to investigate whether hormonal variations during the menstrual cycle are associated with differences in intracranial pressure reflected by ONSD measurements and postoperative outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follicular Phase | – | –Women undergoing elective laparoscopic gynecologic surgery during the follicular phase of the menstrual cycle (approximately days 12-14). Perioperative optic nerve sheath diameter measurements will be performed, and postoperative nausea, vomiting, and cognitive function will be assessed. |
| Luteal Phase | – | –Women undergoing elective laparoscopic gynecologic surgery during the luteal phase of the menstrual cycle (approximately days 20-25). Perioperative optic nerve sheath diameter measurements will be performed, and postoperative nausea, vomiting, and cognitive function will be assessed. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women aged 18 to 45 years with ASA physical status I-II who are scheduled for elective laparoscopic gynecologic surgery at Konya City Hospital. Participants will be observed according to menstrual cycle phase (follicular or luteal phase).
Key inclusion criteria (4 listed)
- Female patients aged 18 to 45 years
- Scheduled for elective laparoscopic gynecologic surgery
- Menstrual cycle in the follicular phase or luteal phase
- American Society of Anesthesiologists (ASA) physical status I-II
Key exclusion criteria (6 listed)
- Irregular menstrual cycle (e.g., polycystic ovary syndrome, early menopause, hypothalamic amenorrhea)
- Pregnancy or breastfeeding
- Neurological disease associated with intracranial pressure changes
- Glaucoma or another eye disease associated with high intraocular pressure
- Previous brain surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Optic Nerve Sheath Diameter
Time frame: Before induction of anesthesia, during surgery, and at the end of surgery
The primary outcome is the comparison of optic nerve sheath diameter (ONSD) between women in the follicular phase and those in the luteal phase of the menstrual cycle undergoing elective laparoscopic gynecologic surgery. ONSD will be measured ultrasonographically in the supine position. For each eye, three horizontal and three vertical measurements will be obtained and averaged.
2 secondary outcomes
Postoperative Nausea and Vomiting
Time frame: Within 24 hours after surgery
Postoperative Cognitive Function
Time frame: Preoperative period and 24 hours after surgery
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 21 Apr 2026.
- Individual participant dataSharing planned: No
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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.
MAHMUT TUTAR, md contact
MAHMUT TUTAR, MD principal investigator
Konya City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menstrual Cycle and Optic Nerve Sheath Diameter, run by Konya City Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 21 Apr 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 Turkey (Türkiye). 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 MAHMUT TUTAR, MD (905552723704, masatu42@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic Nerve Sheath Diameter (time frame: Before induction of anesthesia, during surgery, and at the end of surgery). 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 21 Apr 2026.