Endocrine System DiseasesPhase 1/2NCT00947713
Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With Human Menopausal Gonadotropin (HMG) in Polycystic Ovary Syndrome
A Phase 1/2 study testing low dose human chorionic gonadotropin and Clomiphen citrate plus HMG in people with Endocrine System Diseases and Gonadal Disorders, run by Royan Institute at 1 site in Iran.
Trial summary
The purpose of this study is to compare the effectiveness of low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate to induce ovulation and its endocrine response in patients who had previously failed to ovulate on clomiphen citrate alone. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Endocrine System Diseases, Gonadal Disorders
- What is being tested?
- low dose human chorionic gonadotropin and Clomiphen citrate plus HMG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIran
- Study dates
- Aug 2009to Dec 2010
- Phase
- Phase 1/2
- 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 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with PCOS diagnosed by the Rotterdam criteria
- Previously documented dominant follicle or follicles (R12 mm mean diameter) on transvaginal Ultrasound follicular monitoring while receiving CC at the 150-mg dose in our clinic but have failed to ovulate;
- Primary infertility
- Documented normal uterine cavity and patent tubes by either hysterosalpingogram or laparoscopy and hysteroscopy;
- Male partner had to have a normal semen analysis by World Health Organization criteria.
Who cannot join
- previous history of IVF or ICSI treatments.
- History of hormonal treatment within recent three month (Except OCP, progesterone).
- History of ovarian cutter or Ovarian drilling.
- BMI higher than 30.
- The presence of ovarian cyst (more than 30 mm) during third cycle ultrasound.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Royan institute, Reproductive Medicine Research Centre, ACECR
Tehran, Tehran Province
About this study
Official title: Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With HMG in PCOs Patients With Previous Clomiphene Citrate (CC)-Resistant Anovulation
The purpose of this study is to compare the effectiveness of low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate to induce ovulation and its endocrine response in patients who had previously failed to ovulate on clomiphen citrate alone. The investigators will also compare the effectiveness and endocrine response of this approach with the regimen of adding HMG to clomiphen citrate.
Read the detailed description
Infertile women with PCOS, who have showed resistance to Clomiphen Citrate (150 mg- 5 days) in a previous IUI treatment cycle at Royan Institute (Infertility and Reproductive Medicine Research Centre) will enroll in this prospective randomized clinical trial study and will randomly be divided into three groups.
The study protocol will be assessed by an independent institutional review board and Royan ethics committee. All subjects will be given the written informed consent.
Control group (CC/hMG) will receive the 100 mg CC on days 3 to 7 of that cycle but will receive 150 mg human menopausal gonadotropin (HMG) during days of 7, 8, and 9. One of experimental Group (group B) will receive a 100 mg dose of CC but will receive a 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily when the largest follicle is 12 mm or larger mean diameter. Other experimental group (Group C) will receive a 100 mg dose of CC but will receive a 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily From day 9(without attention to follicle size). In both experimental groups HCG administration will be continued until the largest follicle is 18-20 mm.
Ultrasound measurements of follicle number and growth, ovulation, gestational sac, and serum hormonal levels will be recorded and compared between two groups.
- Conditions
- Endocrine System Diseases, Gonadal Disorders
- Being tested
- low dose human chorionic gonadotropin, Clomiphen citrate plus HMG
- Keywords
- Human chorionic gonadotropin, Clomiphene citrate, chronic anovulation, Polycystic Ovary Syndrome, Follicolugenesis
- Medical subject headings
- Endocrine System Diseases, Gonadal Disorders, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dose human chorionic gonadotropinDrug
Also called human chorionic gonadotropin
patients will receive low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate
Clomiphen citrate plus HMGDrug
patients will receive Clomiphen Citrate plus HMG
| Study group | Role | What they receive |
|---|---|---|
| Low dose hCG group | Experimental | Not described Receives: Drug: low dose human chorionic gonadotropin |
| Clomiphen citrate plus HMG | Active comparator | Not described Receives: Drug: Clomiphen citrate plus HMG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple pregnancy rates, OHSS rate
Measured: Within 20 months after recruiting
Secondary outcomes (4)
Pregnancy rate
Measured: Within 20 months after recruiting
The total dose of ovarian stimulation drugs
Measured: Within 20 months after recruiting
The number of embryos available for transfer
Measured: Within 20 months after recruiting
The embryo implantation rate and The live birth rate
Measured: Within 20 months after recruiting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine System DiseasesStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Investigators
- Mahnaz Ashrafi, Principal investigator, Royan institute, Reproductive Medicine Research Centre, ACECR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947713
- Sponsor's protocol ID
- Royan-Emb-002
- Status last verified
- Apr 2010
- First submitted
- 25 Jul 2009
- Last updated
- 15 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With HMG in PCOs Patients With Previous Clomiphene Citrate (CC)-Resistant Anovulation
- ClinicalTrials.gov ID
- NCT00947713
- Acronym / sponsor ID
- Royan-Emb-002
- Conditions
- Endocrine System Diseases, Gonadal Disorders
- Keywords
- Human chorionic gonadotropin, Clomiphene citrate, chronic anovulation, Polycystic Ovary Syndrome, Follicolugenesis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Jul 2009 (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.
The purpose of this study is to compare the effectiveness of low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate to induce ovulation and its endocrine response in patients who had previously failed to ovulate on clomiphen citrate alone. The investigators will also compare the effectiveness and endocrine response of this approach with the regimen of adding HMG to clomiphen citrate.
Detailed description
Infertile women with PCOS, who have showed resistance to Clomiphen Citrate (150 mg- 5 days) in a previous IUI treatment cycle at Royan Institute (Infertility and Reproductive Medicine Research Centre) will enroll in this prospective randomized clinical trial study and will randomly be divided into three groups.
The study protocol will be assessed by an independent institutional review board and Royan ethics committee. All subjects will be given the written informed consent.
Control group (CC/hMG) will receive the 100 mg CC on days 3 to 7 of that cycle but will receive 150 mg human menopausal gonadotropin (HMG) during days of 7, 8, and 9. One of experimental Group (group B) will receive a 100 mg dose of CC but will receive a 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily when the largest follicle is 12 mm or larger mean diameter. Other experimental group (Group C) will receive a 100 mg dose of CC but will receive a 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily From day 9(without attention to follicle size). In both experimental groups HCG administration will be continued until the largest follicle is 18-20 mm.
Ultrasound measurements of follicle number and growth, ovulation, gestational sac, and serum hormonal levels will be recorded and compared between two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose hCG group | Experimental | Drug: low dose human chorionic gonadotropin |
| Clomiphen citrate plus HMG | Active comparator | Drug: Clomiphen citrate plus HMG |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women with PCOS diagnosed by the Rotterdam criteria
- Previously documented dominant follicle or follicles (R12 mm mean diameter) on transvaginal Ultrasound follicular monitoring while receiving CC at the 150-mg dose in our clinic but have failed to ovulate;
- Primary infertility
- Documented normal uterine cavity and patent tubes by either hysterosalpingogram or laparoscopy and hysteroscopy;
- Male partner had to have a normal semen analysis by World Health Organization criteria.
Key exclusion criteria (5 listed)
- previous history of IVF or ICSI treatments.
- History of hormonal treatment within recent three month (Except OCP, progesterone).
- History of ovarian cutter or Ovarian drilling.
- BMI higher than 30.
- The presence of ovarian cyst (more than 30 mm) during third cycle ultrasound.
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 |
|---|---|---|
| low dose human chorionic gonadotropinAlso: human chorionic gonadotropinpatients will receive low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate | Drug | Low dose hCG group |
| Clomiphen citrate plus HMGpatients will receive Clomiphen Citrate plus HMG | Drug | Clomiphen citrate plus HMG |
Primary outcome
Multiple pregnancy rates, OHSS rate
Time frame: Within 20 months after recruiting
4 secondary outcomes
Pregnancy rate
Time frame: Within 20 months after recruiting
The total dose of ovarian stimulation drugs
Time frame: Within 20 months after recruiting
The number of embryos available for transfer
Time frame: Within 20 months after recruiting
The embryo implantation rate and The live birth rate
Time frame: Within 20 months after recruiting
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 15 Jul 2011.
- Related InfoLink 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.
Mahnaz Ashrafi principal investigator
Royan institute, Reproductive Medicine Research Centre, ACECR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing low dose human chorionic gonadotropin and Clomiphen citrate plus HMG in people with Endocrine System Diseases and Gonadal Disorders, 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 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: finished, as of the sponsor's last update on 15 Jul 2011. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Multiple pregnancy rates, OHSS rate (time frame: Within 20 months after recruiting). 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 15 Jul 2011.