Letrozole or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome.

NCT ID: NCT00956267

Last Updated: 2009-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2009-03-31

Brief Summary

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The purpose of this study is to compare and determine the efficacy of letrozole administration to that of laparoscopic ovarian diathermy (LOD) in infertile women with Polycystic ovary syndrome(PCOS)not responding to treatment with Clomiphene alone.

Detailed Description

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In the letrozole group, withdrawal bleeding was achieved using 10 mg of dydrogesterone tablets for 10 days before stimulation, then 2.5 mg of letrozole oral tablets (Femara; Novartis Pharma Services, Switzerland) daily from day 3 of the menses for 5 days up to six cycles. All patients in the control group underwent laparoscopic ovarian diathermy, then followed up for 6 months.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Letrozole

2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles

Group Type EXPERIMENTAL

Letrozole

Intervention Type DRUG

2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles

Laparoscopic ovarian diathermy (LOD)

Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle.

Group Type ACTIVE_COMPARATOR

Laparoscopic ovarian diathermy (LOD)

Intervention Type PROCEDURE

Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle.

Interventions

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Letrozole

2.5 mg letrozole oral tablets daily from day 3 of the menses for 5 days up to 6 cycles

Intervention Type DRUG

Laparoscopic ovarian diathermy (LOD)

Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* CC resistant PCOS

Exclusion Criteria

* Congenital adrenal hyperplasia
* Cushing syndrome
* Androgen secreting tumors
Minimum Eligible Age

20 Years

Maximum Eligible Age

36 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Mansoura Faculty of Medicine, Mansoura University.

Principal Investigators

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Hatem Abu Hashim, MD. MRCOG

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Abdel Maged Mashaly, MD

Role: STUDY_DIRECTOR

Mansoura University Hospital

Ahmed Badawy, MD.PhD.

Role: STUDY_CHAIR

Mansoura University Hospital

Locations

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Mansoura University Hospitals,OB/GYN department

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

References

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Holzer H, Casper R, Tulandi T. A new era in ovulation induction. Fertil Steril. 2006 Feb;85(2):277-84. doi: 10.1016/j.fertnstert.2005.05.078.

Reference Type BACKGROUND
PMID: 16595197 (View on PubMed)

Bayram N, van Wely M, Kaaijk EM, Bossuyt PM, van der Veen F. Using an electrocautery strategy or recombinant follicle stimulating hormone to induce ovulation in polycystic ovary syndrome: randomised controlled trial. BMJ. 2004 Jan 24;328(7433):192. doi: 10.1136/bmj.328.7433.192.

Reference Type BACKGROUND
PMID: 14739186 (View on PubMed)

Farquhar C, Lilford RJ, Marjoribanks J, Vandekerckhove P. Laparoscopic 'drilling' by diathermy or laser for ovulation induction in anovulatory polycystic ovary syndrome. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001122. doi: 10.1002/14651858.CD001122.pub3.

Reference Type BACKGROUND
PMID: 17636653 (View on PubMed)

Other Identifiers

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FMH-052-K

Identifier Type: -

Identifier Source: secondary_id

MU- 094

Identifier Type: -

Identifier Source: org_study_id

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