Trial Outcomes & Findings for Effect of Pre-operative Depo Medroxyprogesterone Acetate on Serum Anti-mullerian Hormone Level After Laparoscopic Ovarian Cystectomy of Endometriomas (NCT NCT01791413)

Last Updated: 2013-09-09

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Within the first 2 weeks and 3 months after surgery

Results posted on

2013-09-09

Mar.2012-Feb.2013 University Hospital

Assessed for eligibility n=60 Excluded n=20 (15=not compatible with inclusion criteria 5=denied to participate)

Participant milestones
Measure	No Depot Medroxyprogesterone Acetate	Depot Medroxyprogesterone Acetate depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
Overall Study STARTED	20	20
Overall Study COMPLETED	15	19
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal
Measure	No Depot Medroxyprogesterone Acetate	Depot Medroxyprogesterone Acetate depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
Overall Study Lost to Follow-up	5	1

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

Baseline characteristics by cohort
Measure	No Depot Medroxyprogesterone Acetate n=19 Participants	Depot Medroxyprogesterone Acetate n=15 Participants depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants	15 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	32.57 years STANDARD_DEVIATION 5.67 • n=5 Participants	32.46 years STANDARD_DEVIATION 6.46 • n=7 Participants	32.53 years STANDARD_DEVIATION 6.13 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	15 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Thailand	19 participants n=5 Participants	15 participants n=7 Participants	34 participants n=5 Participants

Timeframe: Within the first 2 weeks and 3 months after surgery

Outcome measures
Measure	2 wk Post op : No Depot Medroxyprogesterone Acetate n=19 Participants Percentage changes of serum Anti-Mullerian hormone (AMH) at 2-week post operation	2 wk Post op:Depot Medroxyprogesterone Acetate n=15 Participants depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)Percentage changes of serum Anti-Mullerian hormone (AMH) at 2-week post operation	3 mo. Post op: No Depot Medroxyprogesterone Acetate n=19 Participants Percentage changes of serum Anti-Mullerian hormone (AMH) at 3-month post operation	3 mo. Post op: Depot Medroxyprogesterone Acetate n=15 Participants Percentage changes of serum Anti-Mullerian hormone (AMH) at 3-month post operation
Percentage Changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month Post Operation	-56.86 percentage of serum AMH change Interval -75.1 to -30.78	-77.72 percentage of serum AMH change Interval -97.56 to -69.82	-36.69 percentage of serum AMH change Interval -66.1 to -19.09	-66.84 percentage of serum AMH change Interval -93.23 to -51.21

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Mahidol University

Phone: 66812070264