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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01791413
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : August 23, 2013
Last Update Posted : September 9, 2013
Sponsor:
Information provided by (Responsible Party):
Weena Krutsawad, Mahidol University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: depot medroxyprogesterone acetate Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: depot medroxyprogesterone acetate Drug: depot medroxyprogesterone acetate
DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
No Intervention: No depot medroxyprogesterone acetate


Outcome Measures
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Primary Outcome Measures :
  1. Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation [ Time Frame: Within the first 2 weeks and 3 months after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT01791413


Locations
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Thailand
Department of Obstetrics and Gynecology
Ratchathewi, Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
More Information
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Responsible Party: Weena Krutsawad, Department of Obstetrics and Gynecology, Mahidol University
ClinicalTrials.gov Identifier: NCT01791413    
Other Study ID Numbers: 02-55-13
First Posted: February 15, 2013    Key Record Dates
Results First Posted: August 23, 2013
Last Update Posted: September 9, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Endometriosis
Medroxyprogesterone Acetate
Medroxyprogesterone
Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Contraceptives, Oral, Synthetic
Contraceptive Agents, Male
Antineoplastic Agents, Hormonal
Antineoplastic Agents