Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary

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).

Study Overview

• Status: Unknown
• Conditions: Induction of Ovulation
• Intervention / Treatment: Drug: group A 2.5 mg letrozole oral tablets; Procedure: laparoscopic ovarian drilling

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 25187
    • Recruiting
    • Ain Shams University Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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:

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.

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OVULATION RATE	SERUM PROGESTERON LEVEL	7 DAYS BEFORE NEXT MENSES

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BIOCHEMICAL PREGNANCY RATE	BY SERUM HCG	AFTER 30 DAYS OF INTERVENTION
CLINICAL PREGNANCY RATE	BY FETAL HEART RATE MONITORING BY ULTRASOUND SCAN	AT 6 WEEKS GESTATION

Collaborators and Investigators

• Sponsor: Ain Shams University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: September 7, 2018
• First Submitted That Met QC Criteria: September 7, 2018
• First Posted (ACTUAL): September 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 10, 2018
• Last Update Submitted That Met QC Criteria: September 7, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: letrozol; laparoscopic ovarian drilling
• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole
• Other Study ID Numbers: LOD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No