Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary

Phase 3

• Conditions: Induction of Ovulation
• Interventions: Drug: group A 2.5 mg letrozole oral tablets; Procedure: laparoscopic ovarian drilling

• Registration Number: NCT03664050
• Lead Sponsor: Ain Shams University

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2018-09
• Study First Submitted: 2018-09-07
• Study First Submitted QC: 2018-09-07
• Last Update Submitted: 2018-09-07
• Study First Posted: 2018-09-10
• Last Update Posted: 2018-09-10
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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.

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A Letrozole group	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.
Group B laparoscopic ovarian drilling group	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.

Primary Outcome Measures

Name	Time	Method
OVULATION RATE	7 DAYS BEFORE NEXT MENSES	SERUM PROGESTERON LEVEL

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ain shams university maternity hospital; 🇪🇬 Cairo, Egypt