Clincosm LogoSign in Get a demo

Antimullerian Hormone as an Indicator for Ovarian Response

Sponsor
Ain Shams Maternity Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03291860
Collaborator
(none)
66
Enrollment
11
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ovum retrievum

Study Design

Study Type:
Observational
Anticipated Enrollment :
66 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Antimullerian Hormone as an Indicator fo Ovarian Response in Women Receiving Long GnRH Agonist Protocol in Intracytoplasmic Sperm Injection Cycles
Anticipated Study Start Date :
Nov 10, 2017
Anticipated Primary Completion Date :
Sep 10, 2018
Anticipated Study Completion Date :
Oct 10, 2018

Outcome Measures

Primary Outcome Measures

  1. Difference between AMH levels between good and poor responders in young patients receiving long GnRH agonist protocol for ICSI. [1 month (1 cycle)]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Age:20-40 years old

  2. BMI:20-40kg/m

  3. 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

  1. No Endometriosis by laparoscopy

  2. No prior ovarian surgery; overectomy, ovariectomy or oophrectomy

  3. 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.

  1. 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.

  2. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ain Shams Maternity Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmed Mohammed Selim, Doctor, Ain Shams Maternity Hospital
ClinicalTrials.gov Identifier:
NCT03291860
Other Study ID Numbers:
  • Antimullerian hormone
First Posted:
Sep 25, 2017
Last Update Posted:
Sep 25, 2017
Last Verified:
Sep 1, 2017
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Infertility
Infertility, Female

Study Results

No Results Posted as of Sep 25, 2017