Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary

Sponsor

Ain Shams University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03664050

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Induction of Ovulation	Drug: group A 2.5 mg letrozole oral tablets Procedure: laparoscopic ovarian drilling	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

OVULATION RATE [7 DAYS BEFORE NEXT MENSES]
SERUM PROGESTERON LEVEL

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

patients diagnosed as PCOS according to Roterdam (2003) criteria
patients with Clomiphene resistance, i.e. failure to ovulate following 100 mg CC for 5 days for at least three cycles.
patent fallopian tubes, confirmed by hysterosalpingography or hysteroscopic diagnosis.
normal semen analysis parameters of the patients' spouses according to the modified criteria of the World Health Organization.
normal serum prolactin, thyroid stimulating hormone and 17-OH progesterone.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ain shams university maternity hospital	Cairo		Egypt	25187

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Abdel Shafy El Shahawy, Lecturer, Ain Shams University

ClinicalTrials.gov Identifier:

NCT03664050

Other Study ID Numbers:

First Posted:

Sep 10, 2018

Last Update Posted:

Sep 10, 2018

Last Verified:

Sep 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Ahmed Abdel Shafy El Shahawy, Lecturer, Ain Shams University

letrozol

laparoscopic ovarian drilling

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Letrozole

Study Results

No Results Posted as of Sep 10, 2018