Ovarian StimulationPhase 4NCT00830492
Clomiphene Citrate (CC)/Gonadotropin/Gonadotropin Releasing Hormone (GnRH) Antagonist Versus Gonadotropin/GnRH Agonist
A Phase 4 study testing clomiphene citrate, Ultrasound and GnRH antagonist in people with Ovarian Stimulation, run by Yazd Research & Clinical Center for Infertility at 1 site in Iran.
Trial summary
Objective: To compare the efficacy of using mild ovarian stimulation protocol and conventional stimulation protocol in IVF outcome. Design: Prospective randomized trial Setting: University IVF setting. Patient(s): The study compromised a total 200 subinfertile couple that women had regulary menstruation. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Stimulation
- What is being tested?
- clomiphene citrate, Ultrasound and GnRH antagonist
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIran
- Study dates
- Jan 2008to Dec 2008
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female patient age 18-35 years, presence of a regular and proven ovulatory menstruation cycle with a length of 26-35 days
- basal FSH <10 IU/L and body mass index (BMI) of 18-30 (kg/m²)
- Indication for IVF were unexplained infertility, mild male factor, tubal factor, early stage endometriosis and cervical factor
Who cannot join
- patient requiring ICSI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparisin CC/Gonadotropin/GnRH Antagonist and Gonadotropin/GnRH Agonist in IVF Outcome.
Objective: To compare the efficacy of using mild ovarian stimulation protocol and conventional stimulation protocol in IVF outcome.
Design: Prospective randomized trial
Setting: University IVF setting. Patient(s): The study compromised a total 200 subinfertile couple that women had regulary menstruation.
Intervention(s): Patients were randomized to treatment clomiphene citrate, gonadotropin and GnRH antagonist (100 patients) or GnRH agonist and gonadotropin ( 100 patients).
Main outcome measure: Clinical pregnancy rate.
Key Words: clomiphene citrate, GnRH agonist, GnRH antagonist, in vitro fertilization, pregnancy rate.
- Conditions
- Ovarian Stimulation
- Being tested
- clomiphene citrate, Ultrasound, GnRH antagonist, gonadotopin (HMG), buserelin
- Keywords
- clomiphene citrate, GnRH agonist, GnRH antagonist, in vitro fertilization, clinical pregnancy, pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clomiphene citrateDrug
100 mg from cycle day 3 through 7
UltrasoundProcedure or surgery
cycle day 8
GnRH antagonistDrug
Daily, started with dominant follicle greater than 14 mm (Ganirelix , Organon, Netherlands).
gonadotopin (HMG)Drug
75 IU human menopausal gonadotropin (Menogon, ferring, pharmacenticals , Germany)
buserelinDrug
Buserelin (suprefact, Aventis, Frankfurt, Germany) 500µg subcutaneously (S.C.) everyday for menstrual cycle 21, until the baseline evaluation, which takes place in the first few days of menstruation. If baseline levels of estradiol (<50 pg/ml ) had been achieved, then the dose of buserelin would be reduced to 250µg.
rFSHDrug
150-225 IU recombinant FSH (r_FSH) (Gonal F, Serono, Aubnne, Switzerland) S.C.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | In group A (n=100), the patients were stimulated conventional. They desensitized with buserelin (suprefact, Aventis, Frankfurt, Germany) 500µg subcutaneously (S.C.) everyday for menstrual cycle 21, until the baseline evaluation, which takes place in the first few days of menstruation. If baseline levels of estradiol (<50 pg/ml ) had been achieved, then the dose of buserelin would be reduced to 250µg and ovarian stimulation would commence with 150-225 IU recombinant FSH (r_FSH) (Gonal F, Serono, Aubnne, Switzerland) S.C. Receives: Procedure: Ultrasound; Drug: buserelin; Drug: rFSH |
| clomiphen/gonadotropin/GnRH antagonist | Experimental | Patients in group B ( n=100 ) were stimulated clomiphene citrate ( ) 100 mg from cycle day three through seven and continuous gonadotropin stimulation with of r_FSH 75 IU daily from cycle day 5. Ultrasound in two group was performed on 8 cycle day. In group B 0.25 mg GnRH antagonist (Ganirelix , Organon ,Netherland ) daily was started with dominant follicle ≥14mm and in this day 75 IU human menopoasl gonadotropin (HMG) (Menogon, ferring, pharmacenticals , Germany ) increased to the initial gonadotropin . LH assessment on the day of starting antagonist was performed and if LH was >15 IU/L , cycle was cancelled. Human chorionic gonadotropin 10000 IU ((pregnyl, Organon, Oss, the Netherlands ) was given when 1 to 3 follicles reached 18 mm Receives: Drug: clomiphene citrate; Procedure: Ultrasound; Drug: GnRH antagonist; Drug: gonadotopin (HMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate
Measured: 2 weeks
ovarian stimulation safety
Measured: 3weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian StimulationStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yazd Research & Clinical Center for Infertility
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00830492
- Sponsor's protocol ID
- YazdRCCI1388
- Status last verified
- Jan 2009
- First submitted
- 27 Jan 2009
- Last updated
- 28 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisin CC/Gonadotropin/GnRH Antagonist and Gonadotropin/GnRH Agonist in IVF Outcome.
- ClinicalTrials.gov ID
- NCT00830492
- Acronym / sponsor ID
- YazdRCCI1388
- Conditions
- Ovarian Stimulation
- Keywords
- clomiphene citrate, GnRH agonist, GnRH antagonist, in vitro fertilization, clinical pregnancy, pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yazd Research & Clinical Center for InfertilityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Jan 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.
Objective: To compare the efficacy of using mild ovarian stimulation protocol and conventional stimulation protocol in IVF outcome.
Design: Prospective randomized trial
Setting: University IVF setting. Patient(s): The study compromised a total 200 subinfertile couple that women had regulary menstruation.
Intervention(s): Patients were randomized to treatment clomiphene citrate, gonadotropin and GnRH antagonist (100 patients) or GnRH agonist and gonadotropin ( 100 patients).
Main outcome measure: Clinical pregnancy rate.
Key Words: clomiphene citrate, GnRH agonist, GnRH antagonist, in vitro fertilization, pregnancy rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Procedure: Ultrasound, Drug: buserelin, Drug: rFSHIn group A (n=100), the patients were stimulated conventional. They desensitized with buserelin (suprefact, Aventis, Frankfurt, Germany) 500µg subcutaneously (S.C.) everyday for menstrual cycle 21, until the baseline evaluation, which takes place in the first few days of menstruation. If baseline levels of estradiol (<50 pg/ml ) had been achieved, then the dose of buserelin would be reduced to 250µg and ovarian stimulation would commence with 150-225 IU recombinant FSH (r_FSH) (Gonal F, Serono, Aubnne, Switzerland) S.C. |
| clomiphen/gonadotropin/GnRH antagonist | Experimental | Drug: clomiphene citrate, Procedure: Ultrasound, Drug: GnRH antagonist, Drug: gonadotopin (HMG)Patients in group B ( n=100 ) were stimulated clomiphene citrate ( ) 100 mg from cycle day three through seven and continuous gonadotropin stimulation with of r_FSH 75 IU daily from cycle day 5. Ultrasound in two group was performed on 8 cycle day. In group B 0.25 mg GnRH antagonist (Ganirelix , Organon ,Netherland ) daily was started with dominant follicle ≥14mm and in this day 75 IU human menopoasl gonadotropin (HMG) (Menogon, ferring, pharmacenticals , Germany ) increased to the initial gonadotropin . LH assessment on the day of starting antagonist was performed and if LH was >15 IU/L , cycle was cancelled. Human chorionic gonadotropin 10000 IU ((pregnyl, Organon, Oss, the Netherlands ) was given when 1 to 3 follicles reached 18 mm |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- female patient age 18-35 years, presence of a regular and proven ovulatory menstruation cycle with a length of 26-35 days
- basal FSH <10 IU/L and body mass index (BMI) of 18-30 (kg/m²)
- Indication for IVF were unexplained infertility, mild male factor, tubal factor, early stage endometriosis and cervical factor
Key exclusion criteria (1 listed)
- patient requiring ICSI
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 citrate100 mg from cycle day 3 through 7 | Drug | clomiphen/gonadotropin/GnRH antagonist |
| Ultrasoundcycle day 8 | Procedure or surgery | 2, clomiphen/gonadotropin/GnRH antagonist |
| GnRH antagonistDaily, started with dominant follicle greater than 14 mm (Ganirelix , Organon, Netherlands). | Drug | clomiphen/gonadotropin/GnRH antagonist |
| gonadotopin (HMG)75 IU human menopausal gonadotropin (Menogon, ferring, pharmacenticals , Germany) | Drug | clomiphen/gonadotropin/GnRH antagonist |
| buserelinBuserelin (suprefact, Aventis, Frankfurt, Germany) 500µg subcutaneously (S.C.) everyday for menstrual cycle 21, until the baseline evaluation, which takes place in the first few days of menstruation. If baseline levels of estradiol (<50 pg/ml ) had been achieved, then the dose of buserelin would be reduced to 250µg. | Drug | 2 |
| rFSH150-225 IU recombinant FSH (r_FSH) (Gonal F, Serono, Aubnne, Switzerland) S.C. | Drug | 2 |
Primary outcome
clinical pregnancy rate
Time frame: 2 weeks
ovarian stimulation safety
Time frame: 3weeks
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 28 Jan 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Ultrasound and GnRH antagonist in people with Ovarian Stimulation, run by Yazd Research & Clinical Center for Infertility 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 3 inclusion and 1 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 28 Jan 2009. 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: 2 weeks). The study lists 2 primary outcomes in all. 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 28 Jan 2009.