Evaluation of the Ovarian Reserve in Infertile Patients W... | NCT01941017

Studies
Evaluation of the Ovarian Reserve in Infertile Patients With Endometriosis

NCT01941017

Sponsor

Ain Shams University

Status

Completed

Last Update Posted

Sep 13, 2013Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Endometriosis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Nov 2011Actual

Completion Date

Mar 2012Actual

First Submitted Date

Mar 27, 2013

First Submission Date that Met QC Criteria

Sep 9, 2013

First Posted Date

Sep 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 9, 2013

Last Update Posted Date

Sep 13, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Comparison between Ovarian reserve markers (laboratory or us) in patients with minimal/mild endometriosis and patients with tubal factor infertility including:

Cycle Day 2 or 3 FSH and E2, Serum AMH and antral follicular count

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of ovarian reserve in the 2 groups	Serum AMH and antral follicular count (AFC)	2 years

Secondary Outcomes

Measure	Description	Time Frame
Other Hormonal parameters	Cycle day 2 or 3 FSH and E2	2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

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).

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D004715	Endometriosis

Ancestor Terms

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided