IVF/ICSI Protocols in Poor Responders With Growth Hormone

Female Infertility Due to Diminished Ovarian Reserve Clinical Trial

Official title:

Which is the Best IVF/ICSI Protocol to be Used in Poor Responders Receiving Growth Hormone as an Adjuvant Treatment ? A Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01897324
• Other study ID #: WHC2013
• Status: Completed
• Phase: Phase 4
• First received: July 2, 2013
• Last updated: October 19, 2015
• Start date: July 2013
• Est. completion date: January 2015

Study information

• Verified date: October 2015
• Source: Woman's Health University Hospital, Egypt
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

in this study, we are trying to monitor the effect of the addition of growth hormone on the different down regulation protocols ( long, short, antagonist and microflare). The outcome will be primarily assessed by the clinical pregnancy rates.

Description:

Poor responders undergoing IVF/ICSI cycles have emerged as a major problem. the need to find a proper stimulation protocol is a must. in this study we are trying to detect the best stimulation protocol ,in addition to growth hormone ,that can give the highest pregnancy rates in these patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

ESHRE consensus 2011,At least two of the following three features must be present:

• Advanced maternal age (=40 years) or any other risk factor for POR;

• A previous POR (=3 oocytes with a conventional stimulation protocol);

• An abnormal ovarian reserve test (i.e. AFC < 5-7 follicles or AMH < 0.5 -1.1 ng/ml).

Exclusion Criteria:

• female patients with causes of infertility other than poor ovarian reserve

• females suffering from congenital or acquired uterine anomalies

• females with focal uterine lesions

• females who had previous ovarian surgeries

• females with history of previous exposure to radiotherapy , or chemotherapy

• females refusing to get enrolled in the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Female Infertility Due to Diminished Ovarian Reserve
• Infertility, Female

Intervention

Drug:
• Growth hormone (Norditropin, Novo nordisk)

Locations

Country	Name	City	State
Egypt	private IVF medical center	Giza	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numbers of oocytes retrieved and number of fertilized oocytes	Number of oocytes retrieved on the day of vaginal egg collection guided by trans vaginal ultrasound scan , 35 hours after hCG administration.	2 years	No