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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

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. OVULATION RATE [ Time Frame: 7 DAYS BEFORE NEXT MENSES ]
    SERUM PROGESTERON LEVEL


Secondary Outcome Measures :
  1. BIOCHEMICAL PREGNANCY RATE [ Time Frame: AFTER 30 DAYS OF INTERVENTION ]
    BY SERUM HCG

  2. CLINICAL PREGNANCY RATE [ Time Frame: AT 6 WEEKS GESTATION ]
    BY FETAL HEART RATE MONITORING BY ULTRASOUND SCAN



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664050


Contacts
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Contact: Ahmed Abdelshafy, MD 00201223266380 ahmedshafy@hotmail.com

Locations
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Egypt
Ain shams university maternity hospital Recruiting
Cairo, Egypt, 25187
Contact: Ahmed A Elshahawy, MD    +201223266380    ahmedshafy@hotmail.com   
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Ahmed Abdel Shafy El Shahawy, Lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT03664050     History of Changes
Other Study ID Numbers: LOD
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018

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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

Keywords provided by Ahmed Abdel Shafy El Shahawy, Ain Shams University:
letrozol
laparoscopic ovarian drilling

Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Letrozole
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents