National Research Centre

Medical Research Ethics Committee

MREC Reviewer Comment

Protocol Title

Association of Anti-Müllerian Hormone (AMH) level with Genetic and Clinical Outcomes of Intracytoplasmic Sperm Injection (ICSI) in Women Undergoing Preimplantation Genetic Testing for Aneuploidy (PGTA)An Observational, Prospective Cohort, Comparative Study

Completely satisfied and informative data

Needs Explanation

Comments to the applicant

1-     What is the affiliation of the investigator?

2-     Does the institute of the non-NRC investigator have an ethics committee?

3-     Does the investigator have a scientific role in this study or just overseeing the study and clinical procedures as mentioned?

4-     What is the funding amount? Will it be enough to complete the study?

5-     “Procedures in Details” the mentioned procedures are the standard procedures for IVF? What are the procedures for the study?

6-     “Clinical pregnancy and ongoing pregnancy rates will be recorded and compared between the two arms” what are the 2 arms and when will the participants be tested to decide in which arm they will be. Will any procedures be different for participants in each of the arms?

7-     Risks: will the study require the participants to visit the center more frequently than the usual follow up visits for the pregnancy?

8-     Benefits: How will the observational study improve the outcome?

9- Informed consent should be addressed to females and should mentions the amount of blood that will be drawn for the study, the alternatives for not participating should be clear and the study procedures versus clinical standard procedures should be clarified.

Comment to the Committee

Is the Hayat fertility center an approved research center by the MoH?

Informed consent form:

Needs Modification

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