PCOS Clinical Trial
— HighARTOfficial title:
High Response Predictive Parameters After Controlled Ovarian Stimulation in Women Undergoing Assisted Reproductive Techniques
Polycystic ovarian syndrome (PCOS) patients have an increased risk of ovarian
hyperstimulation syndrome (OHSS) after assisted reproduction techniques (ART). In addition,
these women have a high risk of develop further metabolic disorders. Rotterdam criteria
defined by the European Society of Human Reproduction and Endocrinology (ESHRE) are used for
the diagnosis of PCOS.
The aim of this study is both to determine the prevalence of PCOS in infertile patients who
require ART in our Center and to evaluate the usefulness of each specific diagnosis
criterium within Rotterdam criteria of PCOS as predictor of risk of OHSS. It also seeks to
establish a cohort of patients identified according to specific Rotterdam criteria of PCOS
to assess the incidence of long term complications.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 39 Years |
Eligibility |
Inclusion criteria: Patients with primary infertility undergoing ovarian stimulation for IVF/ICSI plus one of the following criteria: 1. Ovulation dysfunction. 2. Androgen excess: clinical and/or biochemical. 3. Polycystic ovary by transvaginal ultrasound in early follicular phase. 4. AMH>35 pmol/l 5. FSH/LH<1 6. P4 levels on the day of menstrual cycle <10ng/ml and cycle duration <26 days 7. Patients who undergo a second cycle after a previous one in which they were considered high responders (the cycle was canceled due to high risk of OHSS or the patient underwent coasting) Exclusion Criteria: 1. Age <18 or >39 years 2. FSH >10 3. Uterine fibroids requiring surgery 4. Diagnosis of hyperprolactinemia , hypothyroidism, congenital adrenal hyperplasia, Cushing's syndrome, ovarian tumors, adrenal tumors or hypogonadotropic hypogonadism 5. Intake of oral contraceptives three months prior to the completion of IVF 6. Diagnosis of endometriosis (by ultrasound or surgical findings) |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Spain | La Fe University Hospital | Valencia |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigacion Sanitaria La Fe |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity, specificity, negative and positive predictive values of each inclusion criteria (independently and combined) to predict OHSS and high ovarian response after ART | 18 months | No | |
Secondary | Prevalence of metabolic syndrome in the cohort of included patients | 18 months | After COH for ART | No |
Secondary | Incidence of metabolic syndrome in patients with at least one criterion of PCOS | 15 years in average | No | |
Secondary | Incidence of cardiiovascular events in patients with at least one criterion of PCOS | 15 years in average | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06101147 -
Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome
|
Phase 2 | |
Completed |
NCT02037672 -
PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome
|
Phase 4 | |
Completed |
NCT01833949 -
Unilateral Laparoscopic Diathermy Adjusted to Ovarian Volume
|
N/A | |
Completed |
NCT03608813 -
Myo-inositol, D-chiro-inositol and Glucomannan in PCOS
|
||
Not yet recruiting |
NCT05298657 -
The Angiotensin-Melatonin Axis in Poor and Hyper Responders for IVF Treatment
|
||
Completed |
NCT05951309 -
Myoinositol Treatment and Asprosin Levels in PCOS
|
N/A | |
Enrolling by invitation |
NCT04485403 -
The Effect of Ibuprofen on Women With PCOS.
|
Phase 2 | |
Not yet recruiting |
NCT03978013 -
Pomegranate Juice Effect on Oxidative Stress in Infertile Women During IVF Treatment
|
N/A | |
Recruiting |
NCT03767569 -
Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients
|
Phase 3 | |
Completed |
NCT05843955 -
Non-alcoholic Fatty Liver Disease in Women With Polycystic Ovary Syndrome
|
||
Recruiting |
NCT05971849 -
Dampening the Reproductive Axis With Continuous Kisspeptin
|
Phase 1 | |
Recruiting |
NCT04597099 -
Androgen Blockade and Progesterone Augmentation of Gonadotropin Secretion
|
Early Phase 1 | |
Active, not recruiting |
NCT05206448 -
Randomized Controlled Trial of Combined Letrozole and Clomid (CLC II) Versus Letrozole Alone for Women With Anovulation
|
Phase 4 | |
Completed |
NCT04113889 -
Effects of Triple Drug Cocktail Therapy on Metabolic, Endocrine Alterations and Perceived Stress in Patients With Poly Cystic Ovary Syndrome
|
Phase 2 | |
Completed |
NCT04562883 -
Single vs. Group CAPA-IVM Culture of Cumulus-oocyte Complexes
|
N/A | |
Recruiting |
NCT03264638 -
A Clinical and Biological Research of Combined Chinese and Western Medicine in the Treatment of PCOS
|
Phase 2 | |
Completed |
NCT00594217 -
Determining How Quickly Progesterone Slows LH Pulse Frequency
|
Phase 1 | |
Recruiting |
NCT02024984 -
Luteal Phase Versus Follicular Phase Administration of Clomiphene Citrate in PCOS, A Randomized Controlled Trial
|
Phase 1 | |
Completed |
NCT01709942 -
Use of Degarelix in Controlled Ovarian Hyperstimulation (COH) Protocol for Women With PoliCystic Ovarian Syndrome (PCOS)
|
Phase 3 | |
Completed |
NCT01683513 -
Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients
|
Phase 4 |