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Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary

Primary Purpose

Induction of Ovulation

Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
group A 2.5 mg letrozole oral tablets
laparoscopic ovarian drilling
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Induction of Ovulation focused on measuring letrozol, laparoscopic ovarian drilling

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept 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.

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Sites / Locations

  • Ain shams university maternity hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A Letrozole group

Group B laparoscopic ovarian drilling group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

OVULATION RATE
SERUM PROGESTERON LEVEL

Secondary Outcome Measures

BIOCHEMICAL PREGNANCY RATE
BY SERUM HCG
CLINICAL PREGNANCY RATE
BY FETAL HEART RATE MONITORING BY ULTRASOUND SCAN

Full Information

First Posted
September 7, 2018
Last Updated
September 7, 2018
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT03664050
Brief Title
Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary
Official Title
Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
December 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Induction of Ovulation
Keywords
letrozol, laparoscopic ovarian drilling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A Letrozole group
Arm Type
Experimental
Arm Description
2.5 mg letrozole oral tablets will be administered on the 2nd -3rd day of menses and then every day for 5 days.
Arm Title
Group B laparoscopic ovarian drilling group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
group A 2.5 mg letrozole oral tablets
Intervention 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 will be repeated for up to three cycles if the patient failed to conceive.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic ovarian drilling
Intervention 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.
Primary Outcome Measure Information:
Title
OVULATION RATE
Description
SERUM PROGESTERON LEVEL
Time Frame
7 DAYS BEFORE NEXT MENSES
Secondary Outcome Measure Information:
Title
BIOCHEMICAL PREGNANCY RATE
Description
BY SERUM HCG
Time Frame
AFTER 30 DAYS OF INTERVENTION
Title
CLINICAL PREGNANCY RATE
Description
BY FETAL HEART RATE MONITORING BY ULTRASOUND SCAN
Time Frame
AT 6 WEEKS GESTATION

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdelshafy, MD
Phone
00201223266380
Email
ahmedshafy@hotmail.com
Facility Information:
Facility Name
Ain shams university maternity hospital
City
Cairo
ZIP/Postal Code
25187
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed A Elshahawy, MD
Phone
+201223266380
Email
ahmedshafy@hotmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
36165742
Citation
Franik S, Le QK, Kremer JA, Kiesel L, Farquhar C. Aromatase inhibitors (letrozole) for ovulation induction in infertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2022 Sep 27;9(9):CD010287. doi: 10.1002/14651858.CD010287.pub4.
Results Reference
derived

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Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary

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