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

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03085030
• Other study ID #: 3656
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: August 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 593
• Est. completion date: December 1, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Drug:
• Antioxidant Formula
Antioxidant tablet will be taken by the patients
• Placebo
The placebo will be taken by the patients

Locations

Country	Name	City	State
Egypt	Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital	Cairo	Greater Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number oocytes retrieved	The number oocytes retrieved for each participant	At the time of egg retrieval
Secondary	number of good quality eggs	at the time of egg retrieval for each participant	At the time of egg retrieval
Secondary	number of grade 1 and 2 embryos	number of grade 1 and 2 embryos for each participant	number of grade 1 and 2 embryos at time of embryo transfer