Antimullerian Hormone as an Indicator for Ovarian Response

Antimullerian Hormone as an Indicator fo Ovarian Response in Women Receiving Long GnRH Agonist Protocol in Intracytoplasmic Sperm Injection Cycles

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.

Study Overview

• Status: Unknown
• Conditions: Infertility, Female
• Intervention / Treatment: Procedure: Ovum retrievum

• Study Type: Observational
• Enrollment (Anticipated): 66

Contacts and Locations

• Study Contact: Name: Ahmed M Selim, MBBCh; Phone Number: 00201123122003; Email: dr.ahmedselim_89@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

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
4. No Endometriosis by laparoscopy
5. No prior ovarian surgery; overectomy, ovariectomy or oophrectomy
6. 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Ain Shams Maternity Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 10, 2017
• Primary Completion (ANTICIPATED): September 10, 2018
• Study Completion (ANTICIPATED): October 10, 2018

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 22, 2017
• First Posted (ACTUAL): September 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 25, 2017
• Last Update Submitted That Met QC Criteria: September 22, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: Antimullerian hormone

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No