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Completed

NCT Number: NCT03085030

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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Cairo, Greater Cairo, 11956, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Infertile females undergoing IVF/ICSI cycles Poor responders are identified with

  • A previous poor ovarian response (less than 3 oocytes with a conventional ovarian stimulation protocol)
  • An abnormal ovarian reserve test which is considered altered in case of antral follicle count less than 5 follicles or AMH (anti-mullerian hormone) less than 1.5 ng/ml.
  • FSH (follicle stimulating hormone) value more than 10 IU/mL .

Exclusion criteria

  • Any endocrine or metabolic disorders such as diabetes and thyroid dysfunction
  • Any significant uterine anomaly, uterine cavity distortion, fibroids, hydrosalpinx or advanced endometriosis of stage III to IV
  • Severe oligo-astheno-teratozoospermia or azoospermia are excluded, as well.

Treatment and study plan

Antioxidant formula

Drug

Antioxidant tablet will be taken by the patients

Placebo

Drug

The placebo will be taken by the patients

Primary outcomes

  1. 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.

Secondary outcomes

  1. The number oocytes retrieved

    Time frame: At the time of egg retrieval

    The number oocytes retrieved for each participant

  2. number of good quality eggs

    Time frame: At the time of egg retrieval

    at the time of egg retrieval for each participant

  3. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 21, 2017
Registry last updated
Sep 4, 2019

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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