InfertilityPhase 3NCT03009838
Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome
A Phase 3 study testing Letrozole and ovarian drilling in people with Infertility, run by Assiut University at 1 site in Egypt.
Trial summary
Polycystic ovary syndrome is the major cause of anovulatory infertility. Clomiphene citrate is the most commonly used oral agent for ovulation induction in this group, but there are some drawbacks with the use of it. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Letrozole and ovarian drilling
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2017to Aug 2023
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult
Who may be able to join
- History of at least one year of infertility either primary or secondary.
- Body mass index: 25-35
- Normal fallopian tubes
- Normal semen analysis of the husband
- Women who will accept to participate in the study
Who cannot join
- Body mass index above 35
- Contraindication to general anesthesia
- Previous laparoscopic drilling
- Presence of other causes of infertility
- Women who had received metformin, gonadotrophin, oral contraceptives or other hormonal drugs during the preceding 6 months
- Women who intended to start a diet program
- Women who will refuse to participate in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut
Ahmed Abbas, MD, 00201003385183
About this study
Official title: Letrozole Versus Laparoscopic Ovarian Drilling for Clomiphene-resistant Women With Polycystic Ovary Syndrome
Polycystic ovary syndrome is the major cause of anovulatory infertility. Clomiphene citrate is the most commonly used oral agent for ovulation induction in this group, but there are some drawbacks with the use of it.
- Conditions
- Infertility
- Being tested
- Letrozole, ovarian drilling
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetrozoleDrug
Also called femara
oral tablets 2.5 mg
ovarian drillingProcedure or surgery
laparoscopic electrocauterization
| Study group | Role | What they receive |
|---|---|---|
| letrozole | Active comparator | letrozole 2.5 mg oral tablets will be started daily from day 3 of the menses for 5 days in a dose of 5 mg/day Receives: Drug: Letrozole |
| laparoscopic drilling | Active comparator | laparoscopy will be performed using three-puncture technique. Each ovary will be cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using a monopolar electrosurgical needle Receives: Procedure: ovarian drilling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ovulation rate
Measured: 3 months
Secondary outcomes (1)
The mid-cyclic endometrial thickness
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start2 Jan 2017
- Primary completionDec 2022 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Assiut 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009838
- Sponsor's protocol ID
- LEVOD
- Status last verified
- May 2022
- First submitted
- 1 Jan 2017
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Franik S, Le QK, Kremer JA, Kiesel L, Farquhar C. Aromatase inhibitors (letrozole) for ovulation induction in infertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2022 Sep 27;9(9):CD010287. doi: 10.1002/14651858.CD010287.pub4.
PubMed 36165742
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole Versus Laparoscopic Ovarian Drilling for Clomiphene-resistant Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT03009838
- Acronym / sponsor ID
- LEVOD
- Conditions
- Infertility
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 4 Jan 2017 (estimated)
- 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.
Polycystic ovary syndrome is the major cause of anovulatory infertility. Clomiphene citrate is the most commonly used oral agent for ovulation induction in this group, but there are some drawbacks with the use of it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| letrozole | Active comparator | Drug: Letrozoleletrozole 2.5 mg oral tablets will be started daily from day 3 of the menses for 5 days in a dose of 5 mg/day |
| laparoscopic drilling | Active comparator | Procedure: ovarian drillinglaparoscopy will be performed using three-puncture technique. Each ovary will be cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using a monopolar electrosurgical needle |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- History of at least one year of infertility either primary or secondary.
- Body mass index: 25-35
- Normal fallopian tubes
- Normal semen analysis of the husband
- Women who will accept to participate in the study
Key exclusion criteria (7 listed)
- Body mass index above 35
- Contraindication to general anesthesia
- Previous laparoscopic drilling
- Presence of other causes of infertility
- Women who had received metformin, gonadotrophin, oral contraceptives or other hormonal drugs during the preceding 6 months
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 |
|---|---|---|
| LetrozoleAlso: femaraoral tablets 2.5 mg | Drug | letrozole |
| ovarian drillinglaparoscopic electrocauterization | Procedure or surgery | laparoscopic drilling |
Primary outcome
The ovulation rate
Time frame: 3 months
1 secondary outcome
The mid-cyclic endometrial thickness
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Derived from this study: PubMed 36165742Franik S, Le QK, Kremer JA, Kiesel L, Farquhar C. Aromatase inhibitors (letrozole) for ovulation induction in infertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2022 Sep 27;9(9):CD010287. doi: 10.1002/14651858.CD010287.pub4.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Letrozole and ovarian drilling in people with Infertility, run by Assiut 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: status not confirmed, as of the sponsor's last update on 9 May 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Ahmed Abbas, MD (00201003385183, bmr90@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ovulation rate (time frame: 3 months). 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 NCT03009838, which also lists 1 linked publication.
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 9 May 2022.