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

Phase 4

Completed

• Conditions: Infertility, Female
• Interventions: Drug: Antioxidant Formula; Drug: Placebo

• Registration Number: NCT03085030
• Lead Sponsor: Cairo University

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-03-15
• Study First Submitted QC: 2017-03-15
• Study First Posted: 2017-03-21
• Study Start: 2017-04-01
• Primary Completion: 2018-12-01
• Study Completion: 2018-12-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-31
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 593

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 .

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
antioxidant group	Antioxidant Formula	This group will take antioxidant formula tablet once daily orally for one month before IVF/ICSI cycle
control group	Placebo	This group will take placebo tablet once daily orally for one month before IVF/ICSI cycle

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital; 🇪🇬 Cairo, Greater Cairo, Egypt