Back to results

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

Primary Purpose

Infertility, Female

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Antioxidant Formula

Placebo

Sponsored by

Cairo University

About this trial

This is an interventional treatment trial for Infertility, Female focused on measuring infertility, IVF, ICSI, poor responders in IVF/ICSI cycles, antioxidant

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

antioxidant group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

pregnancy rate

pregnancy rate in the antioxidant and placebo groups.

Secondary Outcome Measures

The number oocytes retrieved

The number oocytes retrieved for each participant

number of good quality eggs

at the time of egg retrieval for each participant

number of grade 1 and 2 embryos

number of grade 1 and 2 embryos for each participant

Full Information

NCT ID

First Posted

March 15, 2017

Last Updated

August 31, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03085030

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

April 1, 2017 (Actual)

Primary Completion Date

December 1, 2018 (Actual)

Study Completion Date

December 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility, Female

Keywords

infertility, IVF, ICSI, poor responders in IVF/ICSI cycles, antioxidant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

593 (Actual)

8. Arms, Groups, and Interventions

Arm Title

antioxidant group

Arm Type

Experimental

Arm Description

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

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Antioxidant Formula

Intervention Description

Antioxidant tablet will be taken by the patients

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

The placebo will be taken by the patients

Primary Outcome Measure Information:

Title

pregnancy rate

Description

pregnancy rate in the antioxidant and placebo groups.

Time Frame

pregnancy test will be done 2 weeks after the IVF/ICSI trial for each participant

Secondary Outcome Measure Information:

Title

The number oocytes retrieved

Description

The number oocytes retrieved for each participant

Time Frame

At the time of egg retrieval

Title

number of good quality eggs

Description

at the time of egg retrieval for each participant

Time Frame

At the time of egg retrieval

Title

number of grade 1 and 2 embryos

Description

number of grade 1 and 2 embryos for each participant

Time Frame

number of grade 1 and 2 embryos at time of embryo transfer

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eman F Omran, M.D.

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

City

Cairo

State/Province

Greater Cairo

ZIP/Postal Code

11956

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

No

Learn more about this trial

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

We'll reach out to this number within 24 hrs