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Citrate

No progestin prior to ovulation induction with clomiphene citrate

Progestin prior to beginning ovulation induction with clomiphene citrate (standard care)

The experimental group will have no progestin prior to ovulation induction with clomiphene citrate, while the comparison group will have progestin medication prior to ovulation induction with clomiphene citrate, as per usual care.

Progestin

Jon Havelock, MD

Women with polycystic ovary syndrome (PCOS) can suffer from infertility because they do not produce an egg each month, resulting in irregular periods. As a result, these women often need a medication called clomiphene citrate (clomiphene) to induce ovulation. A traditional 'clomiphene protocol' begins with a short course of progestin treatment to bring on a period (termed a 'withdrawal bleed') before starting the clomiphene medication. Newer evidence, however, has suggested that this progestin-induced shedding of the uterine lining (i.e., withdrawal bleed) may decrease the chances of pregnancy. The purpose of our study is to determine whether withdrawal bleeding has an impact on pregnancy rates for patients with PCOS undergoing a clomiphene cycle.

It is hypothesized that patients who undergo ovulation induction with clomiphene citrate without prior endometrial shedding will have higher clinical pregnancy rates than those who begin with a progestin-induced withdrawal bleed.

Effect of Progestin-Induced Withdrawal Bleed on Ovulation Induction Cycles With Clomiphene Citrate

Effect of Progestin-Induced Endometrial Shedding on Ovulation Induction Cycles With Clomiphene Citrate: A Randomized Study

clinical pregnancy rate (gestational sac seen on ultrasound approximately 6-7 weeks after starting clomiphene) per ovulation

ovulation rate (progesterone \>10nmol/L per clomiphene cycle)

ongoing pregnancy rate (pregnancy with a fetal heartbeat \>12 weeks gestational age)

multiple pregnancy rate (twins and higher order multiples)

endometrial thickness (assessed via transvaginal ultrasound)

University of British Columbia

Anovulation

Progesterone

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Estrogen Receptor Modulators

Selective Estrogen Receptor Modulators

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Progestin-Induced Withdrawal Bleed on Ovulation Induction Cycles With Clomiphene Citrate	NCT01966575	Polycystic Ovar... Infertility	Progestin	18 Years - 38 Years	University of British Columbia
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

Spots Global Cancer Trial Database for endometrial shedding