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Anovulation clinical trials

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NCT ID: NCT01653743 Completed - Clinical trials for Polycystic Ovarian Syndrome

Trial to Assess the Clinical Efficacy and Safety of MSJ-0011 in Inducing Ovulation in Anovulatory or Oligo-ovulatory Japanese Women

Start date: September 2012
Phase: Phase 3
Study type: Interventional

This is an open-label, parallel-group, randomized, multicenter Phase III trial to compare the efficacy and safety of a single 250 microgram (mcg) subcutaneous dose of MSJ-0011 to a single 5,000 international units (IU) intramuscular dose of urinary human chorionic gonadotropin (hCG) in inducing ovulation in Japanese women diagnosed with anovulation or oligo-ovulation. Ovulation induction therapy will be undertaken with follitropin alfa. The primary objective is to show that MSJ-0011 is non-inferior to urinary hCG, as assessed by the ovulation rate.

NCT ID: NCT01289756 Completed - Anovulation Clinical Trials

Influence of Pharmacogenetic Factors, Paroxetine and Clarithromycin on Pharmacokinetics of Clomiphene

Start date: December 2009
Phase: Phase 1
Study type: Interventional

Aim of the study is the clinical validation of the metabolism and the pharmakokinetic of Clomifen in correlation to CYP2D6 and inhibition of CYP3A4.

NCT ID: NCT01250821 Completed - Infertility Clinical Trials

Gonadotrophin Dosage Using a Threshold Nomogram for Ovulation Induction in WHO Group II Anovulatory Infertility

Start date: December 2010
Phase: Phase 4
Study type: Interventional

Ovulation disorders are a common cause of infertility in women. Most of these women can be classified as World Health Organization (WHO) Group II anovulatory patients as they have irregular or absent menstrual cycles but normal serum concentrations of follicle stimulation hormone (FSH) and estradiol. The purpose of this study is to optimize the low-dose-step-up protocol traditionally used for ovulation induction with follicle-stimulating hormone (FSH) in women with anovulatory infertility WHO Group II. Previous studies have established that menstrual cycle history, mean ovarian volume and BMI are significant predictors of FSH threshold dose in women with anovulatory infertility WHO Group II undergoing ovulation induction (Nyboe Andersen et al., 2008). A FSH dosage nomogram has been constructed based on these variables. The aim of this study is to evaluate the clinical use of the nomogram in order to test the use of the variables to determine whether an individualized starting dose of FSH can be used for ovulation induction in anovulatory patients. It is the hypothesis that an individualized starting dose of gonadotrophin will minimize the disadvantages of the treatment and that the stimulation period of the individualized nomogram-based treatment will be 25% shorter than observed in the standard protocol. The primary endpoint is the proportion of patients who reach the criteria for hCG-administration within 14 days of Menopur stimulation. The results of the study will be compared with the data obtained in the Menopur Ovulation Induction Trial (Platteau et al., 2006).

NCT ID: NCT01008319 Completed - Anovulation Clinical Trials

Traditional Clomiphene Citrate Administration vs. Stair-step Approach

Clomid
Start date: October 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the length of time to achieve ovulation and pregnancy with a traditional protocol administration of clomiphene citrate versus a stair step administration. Our hypothesis is by using a stair-step approach in which a period is not induced between administrations of escalating doses of clomiphene citrate, the time to ovulation and pregnancy may be reduced.

NCT ID: NCT01004068 Completed - Clinical trials for Polycystic Ovary Syndrome

Short-term Structured Exercise Training Program Plus Diet Intervention in Patients With Polycystic Ovary Syndrome (PCOS)

Start date: February 2008
Phase: Phase 4
Study type: Interventional

Clomiphene citrate (CC) is the first-line therapy for infertile women with polycystic ovary syndrome (PCOS). Unfortunately, at least 20% of PCOS results are not responsive to CC. Structured exercise training (SET) and diet has been successfully employed to restore ovarian function and to improve reproductive outcomes in obese and overweight women with PCOS. The current study was aimed to test the hypothesis that a short-term SET program plus diet intervention can improve the ovarian response to CC in CC-resistant PCOS patients.

NCT ID: NCT00953355 Completed - Clinical trials for Polycystic Ovary Syndrome

Metformin and Folate Supplementation in Polycystic Ovary Syndrome (PCOS) Patients

Start date: January 2004
Phase: Phase 4
Study type: Interventional

Context: Metformin administration in women with polycystic ovary syndrome (PCOS) improves hormonal and metabolic patterns with beneficial effects in terms of reproductive outcomes and intermediate cardiovascular disease risk factors. Furthermore, reduced folate and vitamin B12, and increased homocysteine (Hcy) levels have been found in type-2 diabetes mellitus patients treated with metformin. Objective: To evaluate if metformin administration exerts any effects on Hcy levels, and if folate supplementation may improve endothelial structure and function in PCOS patients.

NCT ID: NCT00920634 Completed - Anovulation Clinical Trials

Protocol for Drug Use Investigation of Follistim Injection (Study P06132)(COMPLETED)

Start date: July 2007
Phase:
Study type: Observational

The main purpose of this investigation is to collect information about safety and efficacy of Follistim Injection from actual clinical use to induce ovulation in patients with anovulation and oligoovulation due to hypothalamus-pituitary dysfunction. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

NCT ID: NCT00703092 Terminated - PCOS Clinical Trials

Pilot Study:Role of Dietary Fiber in PCOS Anovulation

Start date: February 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether 6 months of fiber supplementation will improve ovulation in women with polycystic ovary syndrome (PCOS).

NCT ID: NCT00665171 Not yet recruiting - Clinical trials for Polycystic Ovary Syndrome

Whole Genome Analysis for the Detection of Key Genes in the Polycystic Ovary Syndrome

Start date: June 2008
Phase: N/A
Study type: Observational

Background: Infertility affects up to 15% of married couples. About half are attributable to female factors, among which anovulation is the leading cause. Some 5% of all women of reproductive age are anovulatory due to the polycystic ovarian syndrome (PCOS). PCOS causes also major health and cosmetic problems and significantly affects quality of life. PCOS is associated with cardiovascular morbidity and Type 2 diabetes mellitus, but it is unclear whether these are caused by the ovarian dysfunction or result from a common denominator. Working hypothesis and aims: Whole genome analysis of multigenerational families in which at least one woman is affected by PCOS may significantly reduce the numbers needed to verify the specific genes, involved in the causation of PCOS. Methods: Registration of multigenerational families and production of personal files with full workup for the presence of PCOS or its absence (in the women participants). Drawing of blood, extraction and preservation of DNA. Analysis of all informative SNPs in the genomes of the participants on a specific microarray chip. Statistical analysis of the results. Expected results: Verification of the loci and putative genes, associated with the appearance of PCOS. Importance: Elucidation of the specific genes underlying the pathology of PCOS. Probable implications to Medicine: Paving the way for targeted treatment of the problems, associated with PCOS, based on the clear knowledge of its underlying cause(s).

NCT ID: NCT00643708 Completed - Infertility Clinical Trials

Ovarian Laser Treatment in Women With Polycystic Ovarian Syndrome: A Randomized Study on the Laser Dose

Start date: January 2005
Phase: Phase 3
Study type: Observational

BACKGROUND: A new effective way, transvaginal ultrasound-guided ovarian interstitial laser-coagulation treatment, in management of anovulation in patients with polycystic ovary syndrome (PCOS), has been presented in the data published. But, the optimal number of laser coagulation points in the ovarian interstitial to be applied at the procedure is unclear. This clinic trial aims to explore an optimal laser dose for this new protocol. METHODS: Fifty-six PCOS women with clomifene citrate-resistant underwent ultrasound-guided transvaginal ovarian interstitial YAG-laser treatment. By random list tableļ¼Œall subjects were randomly divided into four groups in terms of the number of laser coagulation points made in their ovaries as follows: group A, one coagulation point per ovary; group B, two points; group C, three points; group D, four to five points. The size of each point was about 10 mm in diameter on the ovarian plane monitored by transvaginal ultrasound. Postoperative ovulation rate, pregnancy rate and some biochemical parameters were compared among four groups.