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Status unknownNCT03664050Updated Sep 10, 2018

Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary

A Phase 3 interventional study of group A 2.5 mg letrozole oral tablets and laparoscopic ovarian drilling in Induction of Ovulation, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2018-09-10.

Sponsored by Ain Shams University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2018, registered Sep 2018).
Phase
Phase 3
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
Female
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Study 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).

02

Conditions studied

  • Induction of Ovulation

Keywords

  • letrozol
  • laparoscopic ovarian drilling
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 175 are open to participants now.

This study's planned enrollment of 90 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. patients diagnosed as PCOS according to Roterdam (2003) criteria
  2. patients with Clomiphene resistance, i.e. failure to ovulate following 100 mg CC for 5 days for at least three cycles.
  3. patent fallopian tubes, confirmed by hysterosalpingography or hysteroscopic diagnosis.
  4. normal semen analysis parameters of the patients' spouses according to the modified criteria of the World Health Organization.
  5. normal serum prolactin, thyroid stimulating hormone and 17-OH progesterone.
  6. no systemic disease; no gonadotropin or other hormonal drug treatment during the preceding 3 months.

Exclusion criteria

Exclusion Criteria:

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.

-

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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Group A Letrozole group

    2.5 mg letrozole oral tablets will be administered on the 2nd -3rd day of menses and then every day for 5 days.

    Drug: group A 2.5 mg letrozole oral tablets

  • Active comparator
    Group B laparoscopic ovarian drilling group

    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.

    Procedure: laparoscopic ovarian drilling

Interventions

  • Druggroup A 2.5 mg letrozole oral tablets

    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.

  • Procedurelaparoscopic ovarian drilling

    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.

06

What researchers measure

Primary outcomes

  1. OVULATION RATE

    SERUM PROGESTERON LEVEL

    Time frame: 7 DAYS BEFORE NEXT MENSES

Secondary outcomes

  1. BIOCHEMICAL PREGNANCY RATE

    BY SERUM HCG

    Time frame: AFTER 30 DAYS OF INTERVENTION

  2. CLINICAL PREGNANCY RATE

    BY FETAL HEART RATE MONITORING BY ULTRASOUND SCAN

    Time frame: AT 6 WEEKS GESTATION

07

Study locations

1 of 1 sites recruiting
  • Ain shams university maternity hospital
    Cairo, 25187, Egypt
    Recruiting
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03664050
Lead sponsor
Ain Shams University
Responsible party
Ahmed Abdel Shafy El Shahawy (Lecturer, Ain Shams University) — Principal investigator
First posted
Sep 10, 2018
Start date
Jan 1, 2018
Primary completion
Dec 1, 2018 (estimated)
Completion
Dec 1, 2018 (estimated)
Last update
Sep 10, 2018

Study contacts

Ahmed Abdelshafy, MD
Contact
ahmedshafy@hotmail.com
00201223266380

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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