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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03664050

Enrollment

Registered

2018-09-10

Start date

2018-01-01

Completion date

2018-12-01

Last updated

2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Ovulation

Keywords

letrozol, laparoscopic ovarian drilling

Brief 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).

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 35 Years

Healthy volunteers

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. \-

Design outcomes

Primary

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

Secondary

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

Countries

Egypt

Contacts

Primary ContactAhmed Abdelshafy, MD

ahmedshafy@hotmail.com00201223266380

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026