Infertility, Female
Conditions
Keywords
infertility, IVF, ICSI, poor responders in IVF/ICSI cycles, antioxidant
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.
Interventions
Antioxidant tablet will be taken by the patients
DRUGPlacebo
The placebo will be taken by the patients
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
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 group
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed