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

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility, Female
• Intervention / Treatment: Drug: Antioxidant Formula; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 593
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Greater Cairo
    • Cairo, Greater Cairo, Egypt, 11956
      • Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

1. A previous poor ovarian response (less than 3 oocytes with a conventional ovarian stimulation protocol)
2. 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.
3. FSH (follicle stimulating hormone) value more than 10 IU/mL .

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: antioxidant group; This group will take antioxidant formula tablet once daily orally for one month before IVF/ICSI cycle	Drug: Antioxidant Formula; Antioxidant tablet will be taken by the patients
PLACEBO_COMPARATOR: control group; This group will take placebo tablet once daily orally for one month before IVF/ICSI cycle	Drug: Placebo; The placebo will be taken by the patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pregnancy rate	pregnancy rate in the antioxidant and placebo groups.	pregnancy test will be done 2 weeks after the IVF/ICSI trial for each participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number oocytes retrieved	The number oocytes retrieved for each participant	At the time of egg retrieval
number of good quality eggs	at the time of egg retrieval for each participant	At the time of egg retrieval
number of grade 1 and 2 embryos	number of grade 1 and 2 embryos for each participant	number of grade 1 and 2 embryos at time of embryo transfer

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2017
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ACTUAL): December 1, 2018

Study Registration Dates

• First Submitted: March 15, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (ACTUAL): March 21, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 4, 2019
• Last Update Submitted That Met QC Criteria: August 31, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: IVF; infertility; antioxidant; ICSI; poor responders in IVF/ICSI cycles
• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants
• Other Study ID Numbers: 3656 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No