Symptoms and General Pathology

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Neoplasms

Gland and Hormone Related Diseases

Syndrome

Infertility

Polycystic Ovary Syndrome

Anovulation

Genital Diseases

Urogenital Diseases

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Anticoagulants

All Drugs and Chemicals

Reproductive Control Agents

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Citric Acid

Sodium Citrate

Progestins

Progesterone

Clomiphene

Enclomiphene

Zuclomiphene

Medroxyprogesterone Acetate

Medroxyprogesterone

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

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Selective Estrogen Receptor Modulators

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Contraceptives, Oral

Contraceptives, Oral, Hormonal

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Contraceptive Agents, Male

Antineoplastic Agents, Hormonal

Citrate

Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course.

* CC 50 mg oral for 5 days ("Days 3-7")
* If no ovulation, CC 100 mg for 5 days ("Days 12-16")
* If no ovulation, CC 150 mg for 5 days ("Day 21-25")
* Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles

Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC)

* Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES)
* CC 50 mg oral for 5 days (Day 3-7)
* If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses
* If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days
* Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles

Progestin

Clomiphene Citrate

Albert Asante, MD, MPH

Progestin-induced endometrial shedding (PIES) followed by clomiphene citrate is fertility treatment of choice in anovulatory women with polycystic ovary syndrome (PCOS). However, some preliminary data suggest that skipping PIES could result in a higher live birth rate. The investigators are performing the first randomized controlled trial to find out if skipping the use of progestin during fertility treatment of anovulatory PCOS women is associated with improved pregnancy and live birth rates compared to the traditional approach of using progestin prior to use of clomiphene citrate.

This is a prospective randomized trial of clomiphene citrate (CC) preceded by progestin-induced endometrial shedding (PIES) vs CC without PIES in the treatment of infertility in patients with PCOS, for up to 5 treatment cycles.

Participants will be randomized to receive either progestin followed by CC starting on day 3 of the induced menses, or CC without induced menses. Study participants will be monitored at regular 2 to 4 wks intervals for response to medication using ultrasound and hormonal parameters. The maximum dose of CC will not exceed 750 mg/cycle. Treatment will not exceed 5 ovulatory cycles. Participants who are resistant to 150 mg of CC will exit the study.

170 anovulatory PCOS women actively seeking pregnancy, aged 18 through 40 years will be enrolled and randomized in a 1:1 treatment ratio into the two study arms. Anovulation will be the only infertility factor in all patients.

Progestin-induced Endometrial Shedding in PCOS (The PIES in PCOS Study)

Optimizing Fertility Treatment in Women With Polycystic Ovary Syndrome (PCOS) - A Randomized Controlled Trial: The Role of Progestin-induced Endometrial Shedding in PCOS (PIES in PCOS)

Delivery of a viable infant after 24 weeks of pregnancy

University of Illinois at Chicago

Assistant Professor of Obstetrics-Gynecology, Consultant in Reproductive Endocrinology and Infertility

The study was terminated and data cannot be retrieved as the software where data has been stored has been upgraded. We have exhausted efforts to retrieve the data from this software and no study data are available.

Subjects randomized to this group will receive clomiphene citrate (CC) without using progestin throughout their treatment course.

* CC 50 mg oral for 5 days ("Days 3-7")
* If no ovulation, CC 100 mg for 5 days ("Days 12-16")
* If no ovulation, CC 150 mg for 5 days ("Day 21-25")
* Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles

Clomiphene Citrate

Group A (No PIES)

Women randomized to this group will receive progestin to induce endometrial shedding before starting any doses of clomiphene citrate (CC)

* Progestin 10 mg oral for 10 days to induce endometrial shedding (PIES)
* CC 50 mg oral for 5 days (Day 3-7)
* If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding (starting on CD28) and CC 100 mg x 5 days, starting on day 3 of induced menses
* If no ovulation, progestin 10 mg for 10 days to induce endometrial shedding, and CC 150 mg for 5 days
* Exit study if no response to 150 mg CC, or if no pregnancy after 5 ovulatory cycles

Progestin

Clomiphene Citrate

Group B (PIES Group)

Total

Age, Continuous

The study was terminated and data cannot be retrieved as the software where data has been stored has been upgraded. We have exhausted efforts to retrieve the data from this software and no study data are available

Sex: Female, Male

Albert Asante, MD MPH

Live Birth

Overall Study

Immune System Diseases

Nutritional and Metabolic Diseases

Hypersensitivity

Vitamin D Deficiency

Avitaminosis

Deficiency Diseases

Malnutrition

Nutrition Disorders

Bone Density Conservation Agents

Micronutrients

Vitamins

Vitamin D

Cholecalciferol

Trace Elements

Vitamin D3

Calciferol

100 patients who are PCOS and resist CC will receive Vitamin D 10000 IU orally plus 150mg clomid orally for 3 months number and size of growing follicles will be monitored

Adding vitamin D to PCOS patients who are resistant to clomiphene regime for induction will or not improve the Clinical pregnancy rate and will or not increase chances of ovulation and pregnancy.

CLOMID is adrug used for ovulation induction

Clomid

rana nasr

alhassan khedr

effect of vitamin D oral supplementation in poly csytic ovarian women resistant to clomiphene citrate

Polycystic ovarian syndrome is the most common endocrine disorder . It is associated with chronic anovulation and infertility. The diagnosis is made by clinical and ancillary investigations revealing the presence of irregular menstrual cycles, an ovulation , Hyperandrgenemia , and the presence of polycystic ovaries (ovarian morphology as the presence of 12 or more follicles measuring 2-9 mm in diameter and an increased ovarian volume \>10 cm 3) ovulation can be induced with clomiphene citrate (CC), However, \~20%-25% of anovulatory women with PCOS do not respond to CC and are considered to be "clomiphene-resistant( clomiphene citrate resistance means failure to ovulate with 3 months use of clomid at 150 mg/day for 5 days ) Vitamin D may serve as a key in preventing and attenuating the insulin resistance. Vitamin D plays a physiologic role in reproduction including ovarian follicular development and luteinisation, follicle-stimulating hormone sensitivity and progesterone production in human granulosa cells. It also affects glucose homeostasis .

In this trial 100 women with PCO disease that diagnosed by ROTTERDAM CRITERIA (must have any TWO of This findings: Hyperandrogenism, Oligomenorrhea, Polycystic ovaries). Who are taking clomiphene citrate for induction of ovulation and resistant to it, which means failure to ovulate with 3 months of usage of clomid at 150 mg/day for 5 days. They will recieve vitamin D (ossofortin®, Eva Pharma) orally 10000 IU twice weekly for other three months period with clomiphene citrate orally 150 mg/day for 5 days. Number and size of the growing follicles will be monitored before and after taking vitamin D by trans-vaginal ultrasound at day11-14 of the cycle till day 21 to detect effect of vitamin D in ovulation rate.

Effect of Vitamin D Oral Supplementation in Poly Csytic Ovarian Women Resistant to Clomiphene Citrate

Effect of Vitamin D Oral Supplementation in Poly Cystic Ovarian Women Resistant to Clomiphene Citrate

Number of ovulated follicles by trans vaginal ultra sound signs of ovulation

Pregnancy test positive by quantititave see beta HCG level

Measure the endometrium thickness by transvaginal ultrasound

Ain Shams University

rana alaaeldin aly ibrahim nasr

Clinical gynecology professor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Progestin-induced Endometrial Shedding in PCOS (The PIES in PCOS Study)	NCT01718444	Polycystic Ovar... Infertility	Progestin Clomiphene Citr...	18 Years - 40 Years	University of Illinois at Chicago
Progestin-induced Endometrial Shedding in PCOS (The PIES in PCOS Study)	NCT01718444	Polycystic Ovar... Infertility	Progestin Clomiphene Citr...	18 Years - 40 Years	University of Illinois at Chicago
Effect of Vitamin D Oral Supplementation in Poly Csytic Ovarian Women Resistant to Clomiphene Citrate	NCT04916925	Vitamin D Defic... Clomiphene Alle... Polycystic Ovar...	Vitamin D Clomid	18 Years - 40 Years	Ain Shams University
Effect of Vitamin D Oral Supplementation in Poly Csytic Ovarian Women Resistant to Clomiphene Citrate	NCT04916925	Vitamin D Defic... Clomiphene Alle... Polycystic Ovar...	Vitamin D Clomid	18 Years - 40 Years	Ain Shams University

Spots Global Cancer Trial Database for clomid

Every month we try and update this database with for clomid cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for clomid

Every month we try and update this database with for clomid cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for clomid cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.