Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary

Ain Shams University

Status and phase: Unknown; Phase 3

Conditions: Induction of Ovulation

Treatments: Drug: group A 2.5 mg letrozole oral tablets; Procedure: laparoscopic ovarian drilling

Study type: Interventional

Funder types: Other

Identifiers

NCT03664050

LOD

Details and patient eligibility

About

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).

Enrollment: 90 estimated patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Group A Letrozole group

Experimental group

Description:

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

Treatment:

Drug: group A 2.5 mg letrozole oral tablets

Group B laparoscopic ovarian drilling group

Active Comparator group

Description:

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.

Treatment:

Procedure: laparoscopic ovarian drilling