Role of Aromatase Inhibitor to Enhance Ovulation in Poor Responder During Induction With Short Antagonist Protocol in Cases of ICSI

Infertility Indicated for ICSI Clinical Trial

— AIPRICSI  

Official title:

Role of Aromatase Inhibitor to Enhance Ovulation in Poor Responder During Induction With Short Antagonist Protocol in Cases of ICSI(Intracytoplasmic Sperm Injection) a Case Control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02741154
• Other study ID #: MUH 20167
• Secondary ID: MUH20167
• Status: Completed
• Phase: Phase 4
• First received: April 12, 2016
• Last updated: September 4, 2017
• Start date: August 12, 2016
• Est. completion date: September 3, 2017

Study information

• Verified date: September 2017
• Source: Minia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

study the effect of aromataze inhibitor induction together with short stimulation protocol by gonadotrphin releasing hormon antagonist in cases that expected to be poor responder before ICSI

Description:

This is a prospective randomized case control study will be conducted in Maternity hospital IVF unite Minia University after being approved by local ethical committee of obstetrics and gynecology department faculty of medicine, all study details will be explained to patients and informed consent will be obtained before inclusion in the study . enrolled patients will be randomized into two groups using simple randomization by sealed opaque envelops contain serial computer generated numbers Control group will receive HMG 300 IU daily start at first day of menses with follow up by trans vaginal ultrasound (TVUS ) when at least three follicles reach 14mm diameter GnRh antagonist given 0.1 ml continue follow up when at least three follicles reach 17mm in diameter ovum pickup will done under TVUS guide if less than three follicles cycle will be cancelled .

Study group will receive same management plus letrozole 2.5mg daily start at the first day of menses for 5 days and continue with same protocol

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 3, 2017
• Est. primary completion date: August 24, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

Inclusion Criteria:

• infertlity indicated for ICSI

• Ovarian factor

• Tubal factor

• Unexplained infertility

• poor responders

Exclusion Criteria:

• Expected high responder

• Endometriosis

• Male and uterine factors

• Ovarian mass or cyst

Related Conditions & MeSH terms

• Infertility
• Infertility Indicated for ICSI

Intervention

Drug:
• induction with aromataze inhibitor
letrozole 2.5mg once daily start in the first day of menses for 5days
• HMG
HMG 300 IU injection once daily start at first day of menses with follow up by trans vaginal ultrasound (TVUS ) till at least three follicles reach 14 mm in diameter
• GnRh a
antagonist given 0.1 ml injection once daily with continous follow up when at least three follicles reach 17mm in diameter HCG 10.000 IU injection and ovum pick up 24-36hours after injection
• HCG
10.000 IU HCG injection when at least three follicles reach 17mm in diameter

Locations

Country	Name	City	State
Egypt	Minia University	Minia

Sponsors (1)

Lead Sponsor	Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Mitwally MF, Casper RF. Aromatase inhibition improves ovarian response to follicle-stimulating hormone in poor responders. Fertil Steril. 2002 Apr;77(4):776-80. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of follicles per cycle that reach more than 17mm in diameter(quantity of ova)	measurement of the diameter of follicles by transvaginal ultrasoundand description of diameter in report	day of HCG injection
Primary	quality of ova	After ova picking up examination of all ova under microscope and report how many ova reach metaphase II (quality) if more than 3 ova reach metaphase II considered satisfactory quality of ova in the current cycle	day of ovum pick up
Secondary	pregnancy rate	presence of clinical pregnancy	14 days after ovum pick up