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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03085030

Collaborator

(none)

593

Enrollment

Location

Arms

Actual Duration (Months)

29.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Female	Drug: Antioxidant Formula Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

593 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 groupThe 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:

Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2017

Actual Primary Completion Date :

Dec 1, 2018

Actual Study Completion Date :

Dec 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts 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.