Letrozole Versus Laparoscopic Ovarian Drilling in Polycystic Ovary Syndrome

NCT ID: NCT03009838

Last Updated: 2022-05-09

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

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-02

Study Completion Date

2023-08-31

Brief Summary

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Polycystic ovary syndrome is the major cause of anovulatory infertility. Clomiphene citrate is the most commonly used oral agent for ovulation induction in this group, but there are some drawbacks with the use of it.

Detailed Description

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Conditions

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Infertility

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

letrozole 2.5 mg oral tablets will be started daily from day 3 of the menses for 5 days in a dose of 5 mg/day

Group Type ACTIVE_COMPARATOR

Letrozole

Intervention Type DRUG

oral tablets 2.5 mg

laparoscopic drilling

laparoscopy will be performed using three-puncture technique. Each ovary will be cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using a monopolar electrosurgical needle

Group Type ACTIVE_COMPARATOR

ovarian drilling

Intervention Type PROCEDURE

laparoscopic electrocauterization

Interventions

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Letrozole

oral tablets 2.5 mg

Intervention Type DRUG

ovarian drilling

laparoscopic electrocauterization

Intervention Type PROCEDURE

Other Intervention Names

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femara

Eligibility Criteria

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Inclusion Criteria

* History of at least one year of infertility either primary or secondary.
* Body mass index: 25-35
* Normal fallopian tubes
* Normal semen analysis of the husband
* Women who will accept to participate in the study

Exclusion Criteria

* Body mass index above 35
* Contraindication to general anesthesia
* Previous laparoscopic drilling
* Presence of other causes of infertility
* Women who had received metformin, gonadotrophin, oral contraceptives or other hormonal drugs during the preceding 6 months
* Women who intended to start a diet program
* Women who will refuse to participate in the study.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Abbas, MD

Role: CONTACT

00201003385183

Facility Contacts

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Ahmed Abbas, MD

Role: primary

00201003385183

References

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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.

Reference Type DERIVED
PMID: 36165742 (View on PubMed)

Other Identifiers

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LEVOD

Identifier Type: -

Identifier Source: org_study_id

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