Clinical Trials Logo

Clinical Trial Summary

This project explores the implication of the telomere pathway in ovarian premature and regular aging. Telomere length and maintenance underlie several biological processes such cancer, aging, human diseases and the biology of stem cells. The reactivation of telomerase should lead to a rejuvenation of the ovarian tissue and the improvement of fertility. The correlation of telomeric factors in blood and granulosa cells will be studied with the aim of finding telomeric biomarkers of ovarian aging.


Clinical Trial Description

This is a pilot study, randomized, controled, blind, parallelo arm clinical trial with inactive substance and medicine. A pilot study will be developed with a total of 45 individuals from 30 to 45 years old, who represent the most frequent population of women seeking for ART. A control group composed of women with normal ovarian reserve (30 to 45 years old) is needed to compare telomeric and fertility parameters with the group of women with compromised ovarian reserve. Women in the control group irrespective of their age, will have a greater number of follicles compared to women belonging to the group with compromised ovarian reserve. A group of women with diminished ovarian reserve that will take an inactive substance has been incluided to avoid biases and to set the fertility base line for women with compromised ovarian reserve. The use of an inactive substance or placebo will help obtain better quality results. For instance, if Danazol happened to improve the fertility outcome, then, there could be a possibility that the IVF improvement might be due to other components of the pill. Using placebo, this possibility would be eliminated, since the placebo will contain all components of the pill, except Danazol. The development of a pilot study will help us understand the statisticl behavior or the telomeric factors as well as to determine the appropriate number of individuals that shoyuld be recruited in a clinical trial to have results with statistical significance. In addition, a pilot study will help us learn errors or undesired events that may happen during the clinical trial. For instance, if patients cannot follow the indications of their doctors and why, or what proportion of patients will drop the study and the reasons for it. Furthermore, it will also help us understand if there exist a tendency, an indication or even a clear beneficial effect for patients without harming them. The number of participants selected for the study is considered adequate for each group, since each group will be measured in an independent manner. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04058678
Study type Interventional
Source IVI Madrid
Contact
Status Completed
Phase N/A
Start date January 30, 2020
Completion date December 31, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT02896023 - Predictors of Ovarian Reserve in Infertile Women Phase 4
Recruiting NCT02240342 - Bone Marrow Transplantation to Promote Follicle Recruitment in Poor Ovarian Reserve N/A
Completed NCT01268930 - Comparison of Hemostatic Matrix and Bipolar Coagulation in Surgical Treatment of Endometriomas N/A
Completed NCT03492632 - Ovarian Reserve in Patients With Psoriasis
Withdrawn NCT02728245 - Trial Comparing Preoperative Dienogest Therapy Followed by Surgery vs. Upfront Surgery to Save Ovarian Reserve in Young Women With Ovarian Endometrioma Phase 2
Completed NCT05567731 - Effect of GnRH Agonist Treatment Protocols on Ovarian Reserve N/A
Completed NCT03989921 - Ovarian Reserve and Embryo Implantation
Recruiting NCT02995343 - Evaluation of the Ovarian Reserve in Patients Who Hypogastric Arteries and or Uterine Arteries Had Been Ligated N/A
Withdrawn NCT01966536 - CD133 Transplantation to Generate Oocytes in Poor Ovarian Reserve N/A
Recruiting NCT04151173 - Assessment of Ovarian Reserve After Laparoscopic Cystectomy Versus Aspiration/Electrocoagulation in the Treatment of Ovarian Endometrioma N/A
Enrolling by invitation NCT02377128 - Ovarian Reserve Following Bilateral Salpingectomy Versus Tubal Ligation During Cesarean Section N/A
Recruiting NCT03620838 - Endometrioma Per se Versus Treatment Related Reduction in Ovarian Reserve (ERROR-2 Trial)
Completed NCT02009228 - Single-port LC Might be Preferable for Managing Ovarian Dermoid Cyst. Phase 3
Completed NCT04762615 - Impact of Underlying Renal Disease and Immunosuppressive Regimen on Ovarian Reserve in Renal Patients
Recruiting NCT03009370 - The Effect of the Ovarian Reserve on the Recurrent Pregnancy Loss N/A
Completed NCT03621683 - Antioxidants vs. Ovarian Bio-stimulation Therapy to Rescue the Ovarian Reserve N/A
Recruiting NCT05743218 - Clinical Efficacy of Acupuncture on the Liver Meridian in Women With Diminished Ovarian Reserve N/A
Recruiting NCT04487925 - Controlled Ovarian Stimulation Versus Modified Natural Cycles in Poor Responders Phase 4
Terminated NCT01114464 - Impact of Chemotherapy on Ovarian Reserve in Young Women With Breast Cancer N/A
Active, not recruiting NCT00928044 - The Impact of Gynecological Surgery on Ovarian Function in Women of Reproductive Age: Postoperative Changes of Serum Anti-Müllerian Hormone (AMH) N/A