Polycystic Ovary SyndromePhase 4NCT01966575
Effect of Progestin-Induced Withdrawal Bleed on Ovulation Induction Cycles With Clomiphene Citrate
A Phase 4 study testing Progestin in people with Polycystic Ovary Syndrome and Infertility, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Infertility
- What is being tested?
- Progestin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2013to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Polycystic ovary syndrome (Rotterdam 2003 Consensus Criteria) and a diagnosis of anovulatory infertility
- Age 18-38 years
- At least 1 patent fallopian tube (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year)
- Normal semen analysis (total motile sperm count >20million/ml)
- Normal uterine cavity (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year)
- Undergoing ovulation-induction with clomiphene citrate without intra-uterine insemination (IUI)
Who cannot join
- Body mass index (BMI) < 17 kg/m2 or > 40 kg/m2
- Prior treatment with clomiphene citrate
- Presence of a hydrosalpinx (as seen on ultrasound, hysterosalpingogram, hydrotubation or hysterosonogram)
- Those with systemic disease such as diabetes mellitus, uncontrolled thyroid disease, systemic lupus erythematosus and antiphospholipid antibody syndrome
- Any other cause of infertility other than anovulation
Trial locations and contacts
1 site in 1 country.
Canada1 site
Pacific Centre for Reproductive Medicine
Burnaby, British Columbia, V5G 4X7
About this study
Official title: Effect of Progestin-Induced Endometrial Shedding on Ovulation Induction Cycles With Clomiphene Citrate: A Randomized Study
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.
- Conditions
- Polycystic Ovary Syndrome, Infertility
- Being tested
- Progestin
- Keywords
- Polycystic ovary syndrome, Progestin, Endometrial shedding, Ovulation induction cycles, Clomiphene citrate, Clinical pregnancy rate
- Medical subject headings
- Polycystic Ovary Syndrome, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgestinDrug
Also called medroxyprogesterone acetate (MPA), i.e. Provera
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.
| Study group | Role | What they receive |
|---|---|---|
| No withdrawal bleed | Experimental | No progestin prior to ovulation induction with clomiphene citrate Receives: Drug: Progestin |
| Withdrawal Bleed | No intervention | Progestin prior to beginning ovulation induction with clomiphene citrate (standard care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate per ovulation
clinical pregnancy rate (gestational sac seen on ultrasound approximately 6-7 weeks after starting clomiphene) per ovulation
Measured: 6 weeks after starting clomiphene
Secondary outcomes (6)
cumulative pregnancy rate
cumulative pregnancy rate
Measured: assessed 9 months after the ovulation induction cycles
ovulation rate
ovulation rate (progesterone >10nmol/L per clomiphene cycle)
Measured: assessed 1 month after each induced ovulation cycle
ongoing pregnancy rate
ongoing pregnancy rate (pregnancy with a fetal heartbeat >12 weeks gestational age)
Measured: assessed 12 weeks after clinical pregnancy is acheived
miscarriage rate
miscarriage rate
Measured: Assessed 4 months after clinical pregnancy acheived
multiple pregnancy rate
multiple pregnancy rate (twins and higher order multiples)
Measured: Assessed 4 months after clinical pregnancy acheived
endometrial thickness
endometrial thickness (assessed via transvaginal ultrasound)
Measured: Assessed at 1 month after conception
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: Recent findings suggest that letrozole may be a superior Clomiphene Citrate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon Havelock, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966575
- Sponsor's protocol ID
- H13-02187
- Status last verified
- Nov 2014
- First submitted
- 17 Sep 2013
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Progestin-Induced Endometrial Shedding on Ovulation Induction Cycles With Clomiphene Citrate: A Randomized Study
- ClinicalTrials.gov ID
- NCT01966575
- Acronym / sponsor ID
- H13-02187
- Conditions
- Polycystic Ovary Syndrome, Infertility
- Keywords
- Polycystic ovary syndrome, Progestin, Endometrial shedding, Ovulation induction cycles, Clomiphene citrate, Clinical pregnancy rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recent findings suggest that letrozole may be a superior Clomiphene Citrate.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 21 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No withdrawal bleed | Experimental | Drug: ProgestinNo progestin prior to ovulation induction with clomiphene citrate |
| Withdrawal Bleed | No intervention | –Progestin prior to beginning ovulation induction with clomiphene citrate (standard care) |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Polycystic ovary syndrome (Rotterdam 2003 Consensus Criteria) and a diagnosis of anovulatory infertility
- Age 18-38 years
- At least 1 patent fallopian tube (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year)
- Normal semen analysis (total motile sperm count >20million/ml)
- Normal uterine cavity (as demonstrated by hysterosalpingogram, hydrotubation or hysterosonogram within the last year)
Key exclusion criteria (5 listed)
- Body mass index (BMI) < 17 kg/m2 or > 40 kg/m2
- Prior treatment with clomiphene citrate
- Presence of a hydrosalpinx (as seen on ultrasound, hysterosalpingogram, hydrotubation or hysterosonogram)
- Those with systemic disease such as diabetes mellitus, uncontrolled thyroid disease, systemic lupus erythematosus and antiphospholipid antibody syndrome
- Any other cause of infertility other than anovulation
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: medroxyprogesterone acetate (MPA), i.e. ProveraThe 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. | Drug | No withdrawal bleed |
Primary outcome
Clinical pregnancy rate per ovulation
Time frame: 6 weeks after starting clomiphene
clinical pregnancy rate (gestational sac seen on ultrasound approximately 6-7 weeks after starting clomiphene) per ovulation
6 secondary outcomes
cumulative pregnancy rate
Time frame: assessed 9 months after the ovulation induction cycles
ovulation rate
Time frame: assessed 1 month after each induced ovulation cycle
ongoing pregnancy rate
Time frame: assessed 12 weeks after clinical pregnancy is acheived
miscarriage rate
Time frame: Assessed 4 months after clinical pregnancy acheived
multiple pregnancy rate
Time frame: Assessed 4 months after clinical pregnancy acheived
endometrial thickness
Time frame: Assessed at 1 month after conception
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
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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.
Jon Havelock, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Progestin in people with Polycystic Ovary Syndrome and Infertility, run by University of British Columbia at 1 site in Canada.
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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 6 Nov 2014. 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Clinical pregnancy rate per ovulation (time frame: 6 weeks after starting clomiphene). 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 6 Nov 2014.