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Effect of Pre-operative Depo Medroxyprogesterone Acetate on Serum Anti-mullerian Hormone Level After Laparoscopic Ovarian Cystectomy of Endometriomas

NCT ID: NCT01791413

Last Updated: 2013-09-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-03-31

Brief Summary

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The purpose of this study is to evaluate the ovarian reserve changes after preoperative depot medroxyprogesterone acetate (DMPA) in women with ovarian endometrioma undergoing laparoscopic cystectomy.

Detailed Description

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Conditions

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Endometriosis

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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depot medroxyprogesterone acetate

Group Type ACTIVE_COMPARATOR

depot medroxyprogesterone acetate

Intervention Type DRUG

DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)

No depot medroxyprogesterone acetate

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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depot medroxyprogesterone acetate

DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy women 18-40 years old
* A diagnosis of endometrioma with diameter of at least 3 cm.
* Candidates for laparoscopic cystectomy

Exclusion Criteria

* Patients' refusal to participate
* Not candidate for depot medroxyprogesterone acetate such as: cirrhosis, chronic kidney disease, venous thrombosis
* Use of estrogen-suppressive drugs in the preceding 3 months, such as:

Oral contraceptives, GnRH analogues, Progestins, Danazol

* Pathology report present no endometriosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Weena Krutsawad

Department of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Obstetrics and Gynecology

Ratchathewi, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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02-55-13

Identifier Type: -

Identifier Source: org_study_id