Female Infertility Clinical Trial
Official title:
Effect of N-acetyl Cysteine on Oxidative Stress Biochemical Factors and IVF/ICSI Outcomes in Women With Endometrioma: A Randomized, Double-blinded, Phase III Clinical Trial
Oxidative stress has been investigated as a key factor in the pathogenesis and progression of endometrioma. High follicular fluid ROS levels and serum can be related to negative IVF/ICSI outcomes in infertile women with endometrioma. Therefore, the use of antioxidants such as N-acetyl cysteine (NAC) may be reduced complications of endometrioma. To study this hypothesis, we designed a double-blind, randomized clinical trial study that aimed to determine the effect of N-acetyl cysteine (NAC) on stress oxidative factors and pregnancy outcomes in IVF/ICSI cycles in endometrioma patients.
This study will be conducted at Royan institute on 140 women with endometrioma who are eligible for the study after receiving written consent. After randomization, the participants will be divided into two intervention and control groups. Then, they will be received 1200 (2×600) mg of effervescent tablets of NAC or the placebo daily during 6 weeks simultaneous to start standard long agonist or antagonist protocols for induction. Plasma blood will be collect before intervention and at the time of egg retrieval, in addition to, follicular fluid (FF) will be obtained from the mature follicles of each ovary and will be separated by centrifuging and will be frozen until analysis. Then, we will measure the levels of two markers of oxidative stress (TAC: Total antioxidant capacity and SOD: Superoxide dismutase) in plasma and FF of all samples by enzyme-linked immunosorbent assay (ELISA) method. In addition, the pregnancy outcomes will be investigated in treated and untreated groups. Also, we will study the effect of pain severity of by visual analogue scale (VAS) technique. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06239051 -
Greening the Humanitas Fertility Center: How to Build a More Sustainable Medical Daily Routine
|
||
| Recruiting |
NCT05179993 -
Detection of Microplastics in Human Granulosa Cells and in the Follicular Fluid of Women Undergoing ICSI Treatment
|
||
| Recruiting |
NCT03767569 -
Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients
|
Phase 3 | |
| Completed |
NCT03737253 -
Hormone Evaluation in Artificial Reproductive Technology
|
Phase 4 | |
| Not yet recruiting |
NCT02237781 -
Levels of Anti-Mullerian Hormone (AMH) During Ovarian Stimulation With Gonadotropins
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT02237755 -
Clomiphene Citrate in Combination With Gonadotropins for Ovarian Stimulation in Women With Poor Ovarian Response.
|
Phase 2/Phase 3 | |
| Completed |
NCT01477073 -
Multiple Dose FSH-GEX(TM) in Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT00119925 -
'SPRING'-Study: "Subfertility Guidelines: Patient Related Implementation in the Netherlands Among Gynaecologists"
|
N/A | |
| Recruiting |
NCT06098495 -
Looking for a Blood Epigenetic Signature to Predict Female Infertility
|
||
| Completed |
NCT03998553 -
Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women
|
N/A | |
| Completed |
NCT05189145 -
Hormonal Monitoring and Progesterone Adjustment in Frozen Embryo Transfer Cycles
|
N/A | |
| Recruiting |
NCT05050747 -
Study to Assess the Effect of Intrauterine Adminstration of HCG Versus Endometrial Injury by Pipelle
|
||
| Completed |
NCT01620346 -
Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age
|
N/A | |
| Completed |
NCT00315029 -
Patient-Centered Implementation Trial for Single Embryo Transfer
|
N/A | |
| Recruiting |
NCT03080584 -
Effect of 12 Weeks of Acupuncture on AMH and COH in Low Responder Patients
|
N/A | |
| Not yet recruiting |
NCT05106712 -
Vitamin D Supplementation and Improvement of PCOS Therapy and IVF Outcomes in Infertile Saudi Women
|
N/A | |
| Recruiting |
NCT06041204 -
Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism
|
N/A | |
| Completed |
NCT01604044 -
Highly Purified Menotropin (HP-hMG) Versus Recombinant FSH (rFSH) Plus Recombinant LH (rLH) in Intrauterine Insemination Cycles in Women ≥35 Years: a Prospective Randomized Trial.
|
Phase 1 | |
| Completed |
NCT02328924 -
There is a Value of Luteinizing Hormone Predictive of in Vitro Fertilization Treatment Outcome in Antagonist Protocols?
|
Phase 4 | |
| Completed |
NCT04019899 -
Myo-inositol and Vitamin D3 During IVF
|
N/A |