Antimullerian Hormone as an Indicator for Ovarian Response | NCT03291860

Studies
Antimullerian Hormone as an Indicator for Ovarian Response

NCT03291860

Sponsor

Ain Shams Maternity Hospital

Status

Unknown status

Last Update Posted

Sep 25, 2017Actual

Enrollment

66Estimated

Phase

Not provided

Conditions

Infertility, Female

Interventions

Ovum retrievum

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 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2017Estimated

Primary Completion Date

Sep 10, 2018Estimated

Completion Date

Oct 10, 2018Estimated

First Submitted Date

Sep 18, 2017

First Submission Date that Met QC Criteria

Sep 22, 2017

First Posted Date

Sep 25, 2017Actual

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 22, 2017

Last Update Posted Date

Sep 25, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Anti Mullerian hormone (AMH) is gaining place as ovarian marker, chiefly in infertility assistance.

Investigators explored its correlation with oocytes retrieval after long GnRH agonist protocol for stimulation, in younger and older infertile population. Methods: This prospective analysis compiled data of 66 females, receiving ICSI treatment from April 2016 to October 2017. Serum FSH, LH, Estadiol, AMH and antral follicle count were assessed. Outcomes were measured as good (5 to 19 oocytes) and bad responders.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

66Estimated

Name	Type	Description	Arm Group Labels	Other Names
Ovum retrievum	Procedure	assessment of oocytes collected by ovum retrievum to evaluate the discriminatory power of the antimullerian hormone in ICSI cycles

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference between AMH levels between good and poor responders in young patients receiving long GnRH agonist protocol for ICSI.	Measurement of AMH level in patients undergoing controlled ovarian stimulation prior to ICSI using long GnRH agonist protocol. Level will be compared between good and poor responders.	1 month (1 cycle)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age:20-40 years old
BMI:20-40kg/m
Normal baseline hormonal profile (on the 2nd day of the cycle)
- FSH: 2.5-10.2mlU/ml
- LH:1.9-12.5mlU/ml
- Estradiol (E2): <50pg/ml
No Endometriosis by laparoscopy
No prior ovarian surgery; overectomy, ovariectomy or oophrectomy
Female subjects who have at least 1 wash-out cycle (defined as greater than or equal to 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting gonadotrophin releasing hormone (GnRH) agonist therapy

Exclusion Criteria:

1. Age: <20 or >40 years old 2. BMI: <20 or >40kg/m 3. Female subjects with any contraindication for pregnancy. 4. Female subjects with history of tumors of the hypothalamus & pituitary gland.

5. Female subjects with history of ovarian, uterine or mammary cancer. 6. Female subjects with history of hypersensitivity to the active substance of the medications used for ovarian stimulation.

7. Abnormal baseline hormonal profile 8. Endometriosis by laparoscopy 9. Previous ovarian surgery; overectomy, ovariectomy or oophrectomy 10. Female subjects with abnormal gynecological bleeding of unknown etiology

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Sixty six women undergoing ICSI were enrolled in and a written informed consent was obtained from each participant

Sampling Method

Probability Sample

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