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OpenTrials
Completed

NCT Number: NCT01897324

IVF/ICSI Protocols in Poor Responders With Growth Hormone

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.

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Key information

Conditions

Female Infertility Due to Diminished Ovarian Reserve

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

private IVF medical center

Giza, Cairo Governorate, 12311, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Growth hormone (Norditropin, Novo nordisk)

Drug

Primary outcomes

  1. Numbers of oocytes retrieved and number of fertilized oocytes

    Time frame: 2 years

    Number of oocytes retrieved on the day of vaginal egg collection guided by trans vaginal ultrasound scan , 35 hours after hCG administration.

Sponsors and collaborators

Lead sponsor

Woman's Health University Hospital, Egypt

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 11, 2013
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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