Infertility, Female Clinical Trial
Official title:
Effect of Some Antioxidants on the Conception Rate in Poor Responders in IVF Cycles (a Randomized Controlled Trial)
NCT number | NCT03085030 |
Other study ID # | 3656 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | April 1, 2017 |
Est. completion date | December 1, 2018 |
Verified date | August 2019 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Department of Obstetrics and Gynecology, Kasr Al-Ainy hospital | Cairo | Greater Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
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 |
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