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

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ClinicalTrials.gov Identifier: NCT01718444
Recruitment Status : Terminated
First Posted : October 31, 2012
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of Illinois at Chicago

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Infertility Drug: Progestin Drug: Clomiphene Citrate Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : March 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group A (No PIES)

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
Drug: Clomiphene Citrate
Other Name: Clomid
Active Comparator: Group B (PIES Group)

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
Drug: Progestin
Other Names:
  • Provera
  • Medroxyprogesterone acetate
Drug: Clomiphene Citrate
Other Name: Clomid



Primary Outcome Measures :
  1. Live birth [ Time Frame: Within 36 weeks of a positive pregnancy test ]
    Delivery of a viable infant after 24 weeks of pregnancy


Secondary Outcome Measures :
  1. Time to first ovulation [ Time Frame: Within 3 months of start of CC ]
  2. Time to clinical pregnancy [ Time Frame: Within 6 months of start of CC ]
  3. Clinical pregnancy rate [ Time Frame: Within 3 weeks of a positive pregnancy test ]
  4. Miscarriage rate [ Time Frame: Within 20 weeks of pregnancy ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion

  • Women aged 18 - 40, desiring pregnancy
  • Established diagnosis of PCOS confirmed by the Rotterdam criteria
  • Oligo or anovulatory, with menstrual cycles > 35 days apart or less than 9 menstrual cycles per year
  • Normal vaginal ultrasound with endometrial stripe < 12 mm
  • Normal thyroid stimulating hormone (TSH) within past one year
  • Normal prolactin (PRL) within past one year
  • For women with previous successful Clomid treatment, a washout period of at least 2 months is required

Exclusion

  • Regular menstrual cycles occurring less than 35 days apart
  • Evidence of other infertility factors such as endometriosis, tubal factor or male infertility
  • Prior unsuccessful Clomiphene citrate ovulation cycles
  • Abnormal vaginal ultrasound findings such as endometrial polyps, submucous myomas, synechiae
  • Uterine anomaly such as unicornuate or bicornuate uterus
  • Presence of hydrosalpinx
  • Evidence of active endocrinopathy, such as thyroid disorder or hyperprolactinemia
  • Partner with abnormal semen analysis (count < 15 million sperm /ml)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718444


Locations
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Albert Asante, MD, MPH University of Illinois at Chicago

Responsible Party: University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01718444     History of Changes
Other Study ID Numbers: 12-006213
First Posted: October 31, 2012    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Keywords provided by University of Illinois at Chicago:
PCOS
Polycystic ovary syndrome
Infertility
Anovulation
Clomiphene citrate
Clomid
Progestin
Provera
Progesterone
Endometrial shedding

Additional relevant MeSH terms:
Infertility
Genital Diseases, Female
Fertility Agents, Female
Contraceptive Agents, Female
Syndrome
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Genital Diseases, Male
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Citric Acid
Clomiphene
Enclomiphene
Zuclomiphene
Medroxyprogesterone
Medroxyprogesterone Acetate
Progestins
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists