Clinical Trial: Can Antioxidants Affect Pregnancy Rate in Patients With Expected Low Number of Egg Retrieval in IVF Cycles?

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Some Antioxidants on the Conception Rate in Poor Responders in IVF Cycles (a Randomized Controlled Trial)

Brief Summary: The aim of the study is to evaluate the effect of antioxidants on IVF outcome in infertile patients undergoing IVF who are expected to produce low number of eggs compared to a control group. The investigators assumed that the conception rate is higher in those patients taking some antioxidants supplementation. The patients will be given antioxidant drug one month before starting IVF trial once daily by mouth. Uniform protocol of stimulation will be done during the cycle by a type of short protocols known as the antagonist protocol. Egg retrieval will be done under anesthesia. pregnancy test will be done 2 weeks after embryo transfer. The investigators will also assess the number and quality of eggs on the day of egg pick up. In addition, the researchers will assess the number of first and second grade embryos that are put on the day of embryo transfer.

Detailed Summary: The primary aim of this study is to assess the value of antioxidant intake on the pregnancy rate in IVF/ICSI (invitro-fertilization/intracytoplasmic sperm injection) cycles in poor responders. when the participants fulfill the eligibility criteria, informed consent will be taken. Block randomization will be done and the patients are allocated to one of two groups. The first group will take the antioxidant tablet daily orally for one month before the IVF/ICSI cycle. the other group will take placebo following the same regimen as the study group. Antagonist protocol will be done for all participants. Ovum pick up will be done under general anesthesia when one or more oocytes reaches 17 mm. The researchers will do embryo transfer on day 2 or 3 after ovum pickup. pregnancy test will be in blood after 2 weeks of embryo transfer.
Sponsor: Cairo University

Current Primary Outcome: pregnancy rate [ Time Frame: pregnancy test will be done 2 weeks after the IVF/ICSI trial for each participant ]

pregnancy rate in the antioxidant and placebo groups.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The number oocytes retrieved [ Time Frame: At the time of egg retrieval ]
    The number oocytes retrieved for each participant
  • number of good quality eggs [ Time Frame: At the time of egg retrieval ]
    at the time of egg retrieval for each participant
  • number of grade 1 and 2 embryos [ Time Frame: number of grade 1 and 2 embryos at time of embryo transfer ]
    number of grade 1 and 2 embryos for each participant


Original Secondary Outcome: Same as current

Information By: Cairo University

Dates:
Date Received: March 15, 2017
Date Started: April 1, 2017
Date Completion: December 1, 2017
Last Updated: April 4, 2017
Last Verified: April 2017