Antimullerian Hormone as an Indicator for Ovarian Response

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03291860
• Other study ID #: Antimullerian hormone
• Status: Not yet recruiting
• Phase: N/A
• First received: September 18, 2017
• Last updated: September 22, 2017
• Start date: November 10, 2017
• Est. completion date: October 10, 2018

Study information

• Verified date: September 2017
• Source: Ain Shams Maternity Hospital
• Contact: Ahmed M Selim, MBBCh
• Phone: 00201123122003
• Email: dr.ahmedselim_89[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: October 10, 2018
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Procedure:
• Ovum retrievum
assessment of oocytes collected by ovum retrievum to evaluate the discriminatory power of the antimullerian hormone in ICSI cycles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams Maternity Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)