Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary

Induction of Ovulation Clinical Trial

Official title:

Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03664050
• Other study ID #: LOD
• Status: Recruiting
• Phase: Phase 3
• Start date: January 1, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: September 2018
• Source: Ain Shams University
• Contact: Ahmed Abdelshafy, MD
• Phone: 00201223266380
• Email: ahmedshafy[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Induction of Ovulation
• Polycystic Ovary Syndrome

Intervention

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.

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.

Locations

Country	Name	City	State
Egypt	Ain shams university maternity hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OVULATION RATE	SERUM PROGESTERON LEVEL	7 DAYS BEFORE NEXT MENSES
Secondary	BIOCHEMICAL PREGNANCY RATE	BY SERUM HCG	AFTER 30 DAYS OF INTERVENTION
Secondary	CLINICAL PREGNANCY RATE	BY FETAL HEART RATE MONITORING BY ULTRASOUND SCAN	AT 6 WEEKS GESTATION