NCT01941017

Brief Summary

Comparison between Ovarian reserve markers in patients with minimal/mild endometriosis and patients with tubal factor infertility

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
Last Updated

September 13, 2013

Status Verified

September 1, 2013

Enrollment Period

2.6 years

First QC Date

March 27, 2013

Last Update Submit

September 9, 2013

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

  • Assessment of ovarian reserve in the 2 groups

    Serum AMH and antral follicular count (AFC)

    2 years

Secondary Outcomes (1)

  • Other Hormonal parameters

    2 years

Study Arms (2)

Minimal or mild endometriosis

Patients with minimal or mild endometriosis diagnosed via laparoscopy.

Tubal obstruction without endometriosis

Patients with tubal obstruction due to infection or adhesion with absent evidence for endometriosis on laparoscopy

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Group I : patients with minimal or mild endometriosis (I or II) as proven by laparoscopy (n=20). Group II: (control group) patients with tubal obstruction without endometriosis (n=20).

You may qualify if:

  • Age 18-35 years of age. Written and signed informed consent by the patient to participate in the study. Patients with regular menses, both ovaries, serum TSH within normal range, body mass index (BMI) \<30 kg/m2 with normal sperm analysis of the husband.

You may not qualify if:

  • Patients with previous endocrine disorders. Cases in which the cause for infertility was other than endometriosis (except for patients with tubal obstruction, in the control group).
  • Patient with previous surgery for endometriosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 27, 2013

First Posted

September 13, 2013

Study Start

April 1, 2009

Primary Completion

November 1, 2011

Study Completion

March 1, 2012

Last Updated

September 13, 2013

Record last verified: 2013-09