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Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary

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ClinicalTrials.gov Identifier: NCT03664050
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Abdel Shafy El Shahawy, Ain Shams University

Tracking Information
First Submitted Date  ICMJE September 7, 2018
First Posted Date  ICMJE September 10, 2018
Last Update Posted Date September 10, 2018
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
OVULATION RATE [ Time Frame: 7 DAYS BEFORE NEXT MENSES ]
SERUM PROGESTERON LEVEL
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2018)
  • BIOCHEMICAL PREGNANCY RATE [ Time Frame: AFTER 30 DAYS OF INTERVENTION ]
    BY SERUM HCG
  • CLINICAL PREGNANCY RATE [ Time Frame: AT 6 WEEKS GESTATION ]
    BY FETAL HEART RATE MONITORING BY ULTRASOUND SCAN
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary
Official Title  ICMJE Laparoscopic Ovarian Drilling Versus Letrozole In Clomiphene Citrate Resistant Polycystic Ovary: A Randomized Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Induction of Ovulation
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: group A 2.5 mg letrozole oral tablets
  • 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.
    Intervention: Procedure: laparoscopic ovarian drilling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 7, 2018)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2018
Estimated Primary Completion Date December 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

-

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ahmed Abdelshafy, MD 00201223266380 ahmedshafy@hotmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03664050
Other Study ID Numbers  ICMJE LOD
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ahmed Abdel Shafy El Shahawy, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP