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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01897324
Other study ID # WHC2013
Secondary ID
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


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
See also
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Withdrawn NCT02209168 - Differences in Ovarian Reserve Markers and Vitamin D Between Infertile Indian, Arabian and Caucasian Population
Completed NCT02341365 - Vitamin D Influence on Oocyte Donation N/A
Completed NCT02195947 - Antagonist Protocol in Poor Responders Phase 4
Completed NCT02185326 - Microflare Protocol in Poor Responders Phase 4
Recruiting NCT02294500 - Cohort Study to Evaluate Ovarian Function N/A
Recruiting NCT01662466 - Effect of Testosterone Treatment on Embryo Quality Phase 1/Phase 2
Enrolling by invitation NCT02179255 - Human Growth Hormone Pre-treatment for 6 Weeks Prior to Ovulation Induction for IVF Phase 1/Phase 2