Induction of OvulationPhase 3NCT03664050
Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary
A Phase 3 study testing group A 2.5 mg letrozole oral tablets and laparoscopic ovarian drilling in people with Induction of Ovulation, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this work is to compare the clinical outcomes of letrozole with laparoscopic ovarian drilling (LOD) in patients with clomiphene-citrate-resistant polycystic ovary syndrome (PCOS). Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Induction of Ovulation
- What is being tested?
- group A 2.5 mg letrozole oral tablets and laparoscopic 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
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Dec 2018
- 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
- patients diagnosed as PCOS according to Roterdam (2003) criteria
- patients with Clomiphene resistance, i.e. failure to ovulate following 100 mg CC for 5 days for at least three cycles.
- patent fallopian tubes, confirmed by hysterosalpingography or hysteroscopic diagnosis.
- normal semen analysis parameters of the patients' spouses according to the modified criteria of the World Health Organization.
- normal serum prolactin, thyroid stimulating hormone and 17-OH progesterone.
- no systemic disease; no gonadotropin or other hormonal drug treatment during the preceding 3 months.
Who cannot join
- 1- Infertility induced by reasons other than PCOS. 2- uterine cavity lesions or ovarian cyst. 3- >40 years old. 4- body mass index (BMI) >26 kg/m2. 5- contraindications to general anesthesia. 6- history of pelvic surgery. 7- other endocrine diseases. 8- a history of liver or kidney disease.
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams university maternity hospital
Cairo, 25187
Ahmed A Elshahawy, MD, +201223266380, ahmedshafy@hotmail.com
About this study
Official title: Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary: A Randomized Controlled Trial
The aim of this work is to compare the clinical outcomes of letrozole with laparoscopic ovarian drilling (LOD) in patients with clomiphene-citrate-resistant polycystic ovary syndrome (PCOS).
- Conditions
- Induction of Ovulation
- Being tested
- group A 2.5 mg letrozole oral tablets, laparoscopic ovarian drilling
- Keywords
- letrozol, laparoscopic ovarian drilling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
group A 2.5 mg letrozole oral tabletsDrug
2.5 mg letrozole oral tablets will be administered on the 2nd-3rd day of menses and then every day for 5 days. Treatment will be repeated for up to three cycles if the patient failed to conceive.
laparoscopic ovarian drillingProcedure or surgery
Bilateral laparoscopic ovarian drilling, each ovary will be cauterized at 4 points, each for 4 sec at 40 W, at a depth of 7-8 mm and a diameter of 3-5 mm, using a monopolar electrosurgical needle according to the size of each ovary.
| Study group | Role | What they receive |
|---|---|---|
| Group A Letrozole group | Experimental | 2.5 mg letrozole oral tablets will be administered on the 2nd -3rd day of menses and then every day for 5 days. Receives: Drug: group A 2.5 mg letrozole oral tablets |
| Group B laparoscopic ovarian drilling group | Active comparator | bilateral laparoscopic ovarian drilling, each ovary will be cauterized at 4 points, each for 4 sec at 40 W, at a depth of 7-8 mm and a diameter of 3-5 mm, using a monopolar electrosurgical needle according to the size of each ovary. Receives: Procedure: laparoscopic ovarian drilling |
What is being measured
The primary outcome is the main question the study is designed to answer.
OVULATION RATE
SERUM PROGESTERON LEVEL
Measured: 7 DAYS BEFORE NEXT MENSES
Secondary outcomes (2)
BIOCHEMICAL PREGNANCY RATE
BY SERUM HCG
Measured: AFTER 30 DAYS OF INTERVENTION
CLINICAL PREGNANCY RATE
BY FETAL HEART RATE MONITORING BY ULTRASOUND SCAN
Measured: AT 6 WEEKS GESTATION
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Jan 2018
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Dec 2018 (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 Induction of OvulationStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdel Shafy El Shahawy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664050
- Sponsor's protocol ID
- LOD
- Status last verified
- Sep 2018
- First submitted
- 7 Sep 2018
- Last updated
- 10 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03664050
- Acronym / sponsor ID
- LOD
- Conditions
- Induction of Ovulation
- Keywords
- letrozol, laparoscopic ovarian drilling
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Dec 2018 (estimated)
- First posted
- 10 Sep 2018 (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.
The aim of this work is to compare the clinical outcomes of letrozole with laparoscopic ovarian drilling (LOD) in patients with clomiphene-citrate-resistant polycystic ovary syndrome (PCOS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Letrozole group | Experimental | Drug: group A 2.5 mg letrozole oral tablets2.5 mg letrozole oral tablets will be administered on the 2nd -3rd day of menses and then every day for 5 days. |
| Group B laparoscopic ovarian drilling group | Active comparator | Procedure: laparoscopic ovarian drillingbilateral laparoscopic ovarian drilling, each ovary will be cauterized at 4 points, each for 4 sec at 40 W, at a depth of 7-8 mm and a diameter of 3-5 mm, using a monopolar electrosurgical needle according to the size of each ovary. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- patients diagnosed as PCOS according to Roterdam (2003) criteria
- patients with Clomiphene resistance, i.e. failure to ovulate following 100 mg CC for 5 days for at least three cycles.
- patent fallopian tubes, confirmed by hysterosalpingography or hysteroscopic diagnosis.
- normal semen analysis parameters of the patients' spouses according to the modified criteria of the World Health Organization.
- normal serum prolactin, thyroid stimulating hormone and 17-OH progesterone.
Key exclusion criteria (2 listed)
- 1- Infertility induced by reasons other than PCOS. 2- uterine cavity lesions or ovarian cyst. 3- >40 years old. 4- body mass index (BMI) >26 kg/m2. 5- contraindications to general anesthesia. 6- history of pelvic surgery. 7- other endocrine diseases. 8- a history of liver or kidney disease.
- -
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 |
|---|---|---|
| group A 2.5 mg letrozole oral tablets2.5 mg letrozole oral tablets will be administered on the 2nd-3rd day of menses and then every day for 5 days. Treatment will be repeated for up to three cycles if the patient failed to conceive. | Drug | Group A Letrozole group |
| laparoscopic ovarian drillingBilateral laparoscopic ovarian drilling, each ovary will be cauterized at 4 points, each for 4 sec at 40 W, at a depth of 7-8 mm and a diameter of 3-5 mm, using a monopolar electrosurgical needle according to the size of each ovary. | Procedure or surgery | Group B laparoscopic ovarian drilling group |
Primary outcome
OVULATION RATE
Time frame: 7 DAYS BEFORE NEXT MENSES
SERUM PROGESTERON LEVEL
2 secondary outcomes
BIOCHEMICAL PREGNANCY RATE
Time frame: AFTER 30 DAYS OF INTERVENTION
CLINICAL PREGNANCY RATE
Time frame: AT 6 WEEKS GESTATION
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- 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.
Related trials for Induction of Ovulation
Recruiting
LE + CC vs. LE for Ovulation Induction
Letrozole, Clomiphene Citrate
Not yet recruiting
Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist in Controlled Ovarian Stimulation for In Vitro Fertilization: A Randomized Controlled Non-Inferiority Trial With a Concurrent Comparator Cohort Undergoing Progestin-Primed Ovarian Stimulation (PPOS)
Infertility, Female, Ovulation Induction
RecruitingPhase 1
E.N.D.E.A.V.O.R.: An Exemestane Needed Dose Efficacy and Verification as an Ovulation Induction Regimen Study
Poly Cystic Ovary Syndrome
RecruitingPhase 4
Progesterone Supplementation After Letrozole-stimulated Insemination
Infertility
RecruitingPhase 2/3
Autologous Platelet Rich Plasma Intraovarian Infusion for Poor Responders
Poor Response to Ovulation Induction, Infertility, Female
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 group A 2.5 mg letrozole oral tablets and laparoscopic ovarian drilling in people with Induction of Ovulation, run by Ain Shams 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 6 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 10 Sep 2018. 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 Abdelshafy, MD (00201223266380, ahmedshafy@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OVULATION RATE (time frame: 7 DAYS BEFORE NEXT MENSES). 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 NCT03664050, 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 10 Sep 2018.