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

NCT03085030 | Completed Phase 4

• 1 other identifier: 3656
• Study Type: interventional
• Target: 593
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility, Female

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The number oocytes retrieved

  At the time of egg retrieval

• number of good quality eggs

  At the time of egg retrieval

• number of grade 1 and 2 embryos

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

Study Arms (2)

antioxidant group

EXPERIMENTAL

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

Drug: Antioxidant Formula

control group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Antioxidant Formula DRUG

Antioxidant tablet will be taken by the patients

antioxidant group

Placebo DRUG

The placebo will be taken by the patients

control group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital

Cairo, Greater Cairo, 11956, Egypt

Location

MeSH Terms

Conditions

Infertility, Female; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Eman F Omran, M.D.

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer and consultant of Obstetrics and Gynecology

Model Details: 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

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 21, 2017
• Study Start: April 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 4, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)