Polycystic Ovary SyndromeNCT01718444
Progestin-induced Endometrial Shedding in PCOS (The PIES in PCOS Study)
A study testing Progestin and Clomiphene Citrate in people with Polycystic Ovary Syndrome and Infertility, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Infertility
- What is being tested?
- Progestin and Clomiphene Citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
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)
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.
Read the 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.
- Conditions
- Polycystic Ovary Syndrome, Infertility
- Being tested
- Progestin, Clomiphene Citrate
- Keywords
- PCOS, Polycystic ovary syndrome, Infertility, Anovulation, Clomiphene citrate, Clomid, Progestin, Provera, Progesterone, Endometrial shedding
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility, Anovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgestinDrug
Also called Provera, Medroxyprogesterone acetate
Clomiphene CitrateDrug
Also called Clomid
| Study group | Role | What they receive |
|---|---|---|
| Group A (No PIES) | Experimental | 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 Receives: Drug: Clomiphene Citrate |
| Group B (PIES Group) | Active comparator | 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 Receives: Drug: Progestin; Drug: Clomiphene Citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth
Delivery of a viable infant after 24 weeks of pregnancy
Measured: Within 36 weeks of a positive pregnancy test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: The primary investigator moved from academic practice to join a private group, and could not get any one to take over as PI for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Asante, MD MPH, University of Illinois Chicago
- Investigators
- Albert Asante, MD, MPH, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718444
- Sponsor's protocol ID
- 2014-1070
- Status last verified
- Sep 2020
- First submitted
- 19 Oct 2012
- Last updated
- 29 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01718444
- Acronym / sponsor ID
- 2014-1070
- Conditions
- Polycystic Ovary Syndrome, Infertility
- Keywords
- PCOS, Polycystic ovary syndrome, Infertility, Anovulation, Clomiphene citrate, Clomid, Progestin, Provera
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The primary investigator moved from academic practice to join a private group, and could not get any one to take over as PI for the study.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Posted 29 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (No PIES) | Experimental | Drug: Clomiphene CitrateSubjects 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 |
| Group B (PIES Group) | Active comparator | Drug: Progestin, Drug: Clomiphene CitrateWomen 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProgestinAlso: Provera, Medroxyprogesterone acetate | Drug | Group B (PIES Group) |
| Clomiphene CitrateAlso: Clomid | Drug | Group A (No PIES), Group B (PIES Group) |
Primary outcome
Live Birth
Time frame: Within 36 weeks of a positive pregnancy test
Delivery of a viable infant after 24 weeks of pregnancy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Asante, MD, MPH principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progestin and Clomiphene Citrate in people with Polycystic Ovary Syndrome and Infertility, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live Birth (time frame: Within 36 weeks of a positive pregnancy test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2020.