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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

593 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2018-12-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The first group will take antioxidant drug orally once daily for one month before IVF/ICSI cycle.

The second group will take placebo with a same regimen as the antioxidant group

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Both the antioxidant and the placebo will be put in sealed envelops with a number on it. the number denotes its order in the randomization process. The investigator, care providers and the outcome assessors will not know the allocated group of the participants. The bio-statistician will prepare the table of random numbers. the pharmacist will prepare the sealed envelopes according to the table of randomization. Independent nurse will bring the sealed envelope of the participant from the pharmacy without knowing whether the envelope contains drug or the placebo.

Study Groups

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antioxidant group

This group will take antioxidant formula tablet once daily orally for one month before IVF/ICSI cycle

Group Type EXPERIMENTAL

Antioxidant Formula

Intervention Type DRUG

Antioxidant tablet will be taken by the patients

control group

This group will take placebo tablet once daily orally for one month before IVF/ICSI cycle

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The placebo will be taken by the patients

Interventions

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Antioxidant Formula

Antioxidant tablet will be taken by the patients

Intervention Type DRUG

Placebo

The placebo will be taken by the patients

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No