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Completed

NCT Number: NCT02195947

Antagonist Protocol in Poor Responders

The effect of use of the growth hormone with antagonist protocol on the outcome of the IVF/ICSI cycles in poor responders.

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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

Kasr Al Aini

Cairo, Egypt

About this study

Two groups of poor responder female patients planned to receive the antagonist IVF/ICSI protocol are randomized to whether or not to add growth hormone to their protocol.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • females fulfilling the criteria of the ESHRE consensus 2011:
  • at least two of the following three features must be present:
  • dvanced maternal age (≥40 years) or any other risk factor for POR
  • 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

  • women who suffer from any other cause of infertility other than poor ovarian reserve
  • refusal of the patient to consent for using her data in the study.

Treatment and study plan

growth hormone

Drug

Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.

Other names: Norditropin, Novo nordisk

Primary outcomes

  1. Live birth rate

    Time frame: Up to 9 months

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: Up to 5 weeks

Other outcomes

  1. Chemical pregnancy rate

    Time frame: 5 weeks

  2. Early miscarriage rate

    Time frame: Up to 12 weeks

  3. Ongoing pregnancy rate

    Time frame: Up to 12 weeks

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Does the Addition of Growth Hormone to the Invitro Fertilization/ Intracytoplasmic Sperm Injection Antagonist Protocol Improve Outcome in Poor Responders? A Randomized Controlled Trial

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 21, 2014
Registry last updated
Nov 11, 2021

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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