InfertilityPhase 4NCT01219101
The Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination
A Phase 4 study testing clomiphene citrate with ethinyl esteradiol and clomiphene citrate with plasebo in people with Infertility, run by Royan Institute at 1 site in Iran.
Trial summary
According to the studies CC is successful at inducing ovulation in 50%-75% of cases, but only 30-40% becomes pregnant. The difference has been attributed to a negative action of clomifen citrate(CC) in the form of prolonged antiestrogenic effects on endometrial receptivity. Read more about this study
- Who is it for?
- Ages 25 to 30 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- clomiphene citrate with ethinyl esteradiol and clomiphene citrate with plasebo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteIran
- Study dates
- Mar 2011to Feb 2013
- 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 25 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- The patients with first treatment cycle
- Age between 25 and 30 years,
- Infertility for at least 2 years' duration,
- Oligomenorrhea or amenorrhea associated with a positive Progesterone challenge test
- Women with normal concentrations of prolactin, free thyroxin and thyroid-stimulating hormone (TSH)
Who cannot join
- Women whose partners had an abnormal semen analysis according to World Health Organization
- Women who had uterine or tubal abnormalities on hysterosalpingography, and women who had a body mass index of >30 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination
According to the studies CC is successful at inducing ovulation in 50%-75% of cases, but only 30-40% becomes pregnant. The difference has been attributed to a negative action of clomifen citrate(CC) in the form of prolonged antiestrogenic effects on endometrial receptivity. For avoiding of these negative effects, giving ethinyl estradiol in sufficient dosages may be effective. The purpose of this study is comparing pregnancy rates after IUI in women who use CC alone and those who use CC in combination with ethinyl estradiol
Read the detailed description
The proposal of This study approved by our institutional review boards and institution's ethical committee, and all Participants will sign a written consent before enter to study. All patients will be randomly divided into two groups, A and B. Stimulation will begin on day 3 with the administration of 100 mg of clomifen citrate(CC) daily for 5 days. On day 8, ethinyl estradiol will be given daily for 5 days in group A and placebo will be given for 5 days in group B. Plasma levels of estradiol(E2), Luteinizing hormone (LH) and Follicle-stimulating hormone (FSH) will be evaluated on days 3 and 13 of the menstrual cycle. Ultrasound examination will be done on days 3, 13 and days of HCG administration and IUI for determining of endometrial thickness, number of follicles and size of the dominant follicle.
When the diameter of at least one follicle reached equal or greater than 18 mm, human chronic gonadotrophin (HCG) 10,000 IU will be administered.
The pulsatility index also will be recorded in both uterine arteries on day of HCG administration. A single IUI will be performed 24-36 hours after the administration of hCG. Pregnancy will be confirmed by increasing level of concentration of serum βHCG which will be assessed 14 days after IUI
- Conditions
- Infertility
- Being tested
- clomiphene citrate with ethinyl esteradiol, clomiphene citrate with plasebo
- Keywords
- Ethinyl estradiol, Polycystic ovary syndrome, Intrauterine insemination
- Medical subject headings
- Infertility, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clomiphene citrate with ethinyl esteradiolDrug
Also called Drug Administration
Clomiphene citrate is used in combination of ethinyl estradiol (0.05 mg for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination
clomiphene citrate with plaseboDrug
Also called Drug administration
Clomiphene citrate is used in combination of placebo (for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination
| Study group | Role | What they receive |
|---|---|---|
| clomiphene citrate and ethinyl estradiol | Experimental | Clomiphene citrate is used in combination of ethinyl estradiol (0.05 mg for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination Receives: Drug: clomiphene citrate with ethinyl esteradiol |
| clomiphene citrate and placebo | Active comparator | Clomiphene citrate is used in combination of placebo (for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination Receives: Drug: clomiphene citrate with plasebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy rate
Usage of clomifen citrate on special days can increase pregnancy rate
Measured: 4-6 weeks after embryos transfer(ET)
Secondary outcomes (2)
Duration of stimulation days
usage of clomiphen citrate with ethyl estradiol in patients with poly cystic ovary can stimulate ovulation
Measured: 5 days
Endometrial thickness
effect of using drugs to increase endometrial thickness
Measured: 13 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startMar 2011
- Primary completionNov 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- hamid gourabi, PhD, Study chair, President of Royan InstituteAshraf Moieni, MD, Study director, Scientific Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219101
- Sponsor's protocol ID
- Royan-Emb-010
- Status last verified
- Mar 2009
- First submitted
- 9 Oct 2010
- Last updated
- 6 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Moini A, Ahmadi F, Jahangiri N, Ahmadi J, Akhoond MR. A randomized controlled trial evaluating the effect of ethinyl estradiol during clomiphene citrate cycles among women with polycystic ovary syndrome. Int J Gynaecol Obstet. 2015 Nov;131(2):129-32. doi: 10.1016/j.ijgo.2015.06.032. Epub 2015 Sep 8.
PubMed 26391671
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
- Evaluate the Effect of Ethinyl Estradiol on Polycystic Ovary Syndrome Women Undergoing Intrauterine Insemination
- ClinicalTrials.gov ID
- NCT01219101
- Acronym / sponsor ID
- Royan-Emb-010
- Conditions
- Infertility
- Keywords
- Ethinyl estradiol, Polycystic ovary syndrome, Intrauterine insemination
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Mar 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 13 Oct 2010 (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.
According to the studies CC is successful at inducing ovulation in 50%-75% of cases, but only 30-40% becomes pregnant. The difference has been attributed to a negative action of clomifen citrate(CC) in the form of prolonged antiestrogenic effects on endometrial receptivity. For avoiding of these negative effects, giving ethinyl estradiol in sufficient dosages may be effective. The purpose of this study is comparing pregnancy rates after IUI in women who use CC alone and those who use CC in combination with ethinyl estradiol
Detailed description
The proposal of This study approved by our institutional review boards and institution's ethical committee, and all Participants will sign a written consent before enter to study. All patients will be randomly divided into two groups, A and B. Stimulation will begin on day 3 with the administration of 100 mg of clomifen citrate(CC) daily for 5 days. On day 8, ethinyl estradiol will be given daily for 5 days in group A and placebo will be given for 5 days in group B. Plasma levels of estradiol(E2), Luteinizing hormone (LH) and Follicle-stimulating hormone (FSH) will be evaluated on days 3 and 13 of the menstrual cycle. Ultrasound examination will be done on days 3, 13 and days of HCG administration and IUI for determining of endometrial thickness, number of follicles and size of the dominant follicle.
When the diameter of at least one follicle reached equal or greater than 18 mm, human chronic gonadotrophin (HCG) 10,000 IU will be administered.
The pulsatility index also will be recorded in both uterine arteries on day of HCG administration. A single IUI will be performed 24-36 hours after the administration of hCG. Pregnancy will be confirmed by increasing level of concentration of serum βHCG which will be assessed 14 days after IUI
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clomiphene citrate and ethinyl estradiol | Experimental | Drug: clomiphene citrate with ethinyl esteradiolClomiphene citrate is used in combination of ethinyl estradiol (0.05 mg for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination |
| clomiphene citrate and placebo | Active comparator | Drug: clomiphene citrate with plaseboClomiphene citrate is used in combination of placebo (for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination |
Who may qualify
- Ages
- 25 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The patients with first treatment cycle
- Age between 25 and 30 years,
- Infertility for at least 2 years' duration,
- Oligomenorrhea or amenorrhea associated with a positive Progesterone challenge test
- Women with normal concentrations of prolactin, free thyroxin and thyroid-stimulating hormone (TSH)
Key exclusion criteria (2 listed)
- Women whose partners had an abnormal semen analysis according to World Health Organization
- Women who had uterine or tubal abnormalities on hysterosalpingography, and women who had a body mass index of >30 kg/m2.
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 |
|---|---|---|
| clomiphene citrate with ethinyl esteradiolAlso: Drug AdministrationClomiphene citrate is used in combination of ethinyl estradiol (0.05 mg for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination | Drug | clomiphene citrate and ethinyl estradiol |
| clomiphene citrate with plaseboAlso: Drug administrationClomiphene citrate is used in combination of placebo (for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination | Drug | clomiphene citrate and placebo |
Primary outcome
Clinical Pregnancy rate
Time frame: 4-6 weeks after embryos transfer(ET)
Usage of clomifen citrate on special days can increase pregnancy rate
2 secondary outcomes
Duration of stimulation days
Time frame: 5 days
Endometrial thickness
Time frame: 13 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
- Derived from this study: PubMed 26391671Moini A, Ahmadi F, Jahangiri N, Ahmadi J, Akhoond MR. A randomized controlled trial evaluating the effect of ethinyl estradiol during clomiphene citrate cycles among women with polycystic ovary syndrome. Int J Gynaecol Obstet. 2015 Nov;131(2):129-32. doi: 10.1016/j.ijgo.2015.06.032. Epub 2015 Sep 8.
- Royan InstituteLink provided by the sponsor.
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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.
hamid gourabi, PhD study chair
President of Royan Institute
Ashraf Moieni, MD study director
Scientific Board
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 clomiphene citrate with ethinyl esteradiol and clomiphene citrate with plasebo in people with Infertility, run by Royan Institute at 1 site in Iran.
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 5 inclusion and 2 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: finished, 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 Iran. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 4-6 weeks after embryos transfer(ET)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01219101, which also lists 1 linked publication.
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.